const {
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  PageBreak, TabStopType, TabStopPosition, Comment, CommentRangeStart,
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} = require('docx');
const fs = require('fs');

// ============================================================
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// ============================================================

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// ============================================================
// TABLE HELPERS
// ============================================================

function makeTableCell(children, opts = {}) {
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// ============================================================
// DOCUMENT CONTENT
// ============================================================

const children = [];

// --- TITLE PAGE ---
children.push(emptyLine());
children.push(emptyLine());
children.push(new Paragraph({
  alignment: AlignmentType.CENTER, spacing: { after: 120, line: 360 },
  children: [new TextRun({ text: 'Evaluation Of Holmium Yag Laser Versus Cold Knife In Optical', font: 'Times New Roman', size: 28, bold: true })]
}));
children.push(new Paragraph({
  alignment: AlignmentType.CENTER, spacing: { after: 120, line: 360 },
  children: [new TextRun({ text: 'Internal Uretherotomy For Management Of Anterior Uretheral', font: 'Times New Roman', size: 28, bold: true })]
}));
children.push(new Paragraph({
  alignment: AlignmentType.CENTER, spacing: { after: 200, line: 360 },
  children: [new TextRun({ text: 'Stricture < 1.5 cm : A Comparative Quasi Experimental Study', font: 'Times New Roman', size: 28, bold: true })]
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children.push(new Paragraph({
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  children: [new TextRun({ text: 'DR. HAFIZ NAVEED UL HASSAN SAJID', font: 'Times New Roman', size: 24, bold: true })]
}));
children.push(new Paragraph({
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  children: [new TextRun({ text: 'Post Graduate Resident MS (Urology)', font: 'Times New Roman', size: 24 })]
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  children: [new TextRun({ text: 'under supervision of', font: 'Times New Roman', size: 24 })]
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children.push(new Paragraph({
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  children: [new TextRun({ text: 'PROF DR. NISAR AHMAD', font: 'Times New Roman', size: 24, bold: true })]
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  children: [new TextRun({ text: 'PROFESSOR OF UROLOGY', font: 'Times New Roman', size: 24 })]
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  children: [new TextRun({ text: 'SAHIWAL TEACHING HOSPITAL, SAHIWAL', font: 'Times New Roman', size: 24 })]
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  children: [new TextRun({ text: 'University of Health Sciences, Lahore Pakistan', font: 'Times New Roman', size: 24 })]
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children.push(pageBreak());

// --- SYNOPSIS COVER PAGE ---
children.push(new Paragraph({
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  children: [new TextRun({ text: 'UNIVERSITY OF HEALTH SCIENCES, LAHORE', font: 'Times New Roman', size: 28, bold: true })]
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children.push(para('Title of Research Project:', { bold: true }));
children.push(para('Evaluation of Holmium Yag Laser versus cold knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study'));
children.push(emptyLine());
children.push(mixedPara([
  { text: 'Synopsis submitted for: ', bold: true },
  { text: 'M.S Urology' },
  { text: '           Discipline: ', bold: true },
  { text: 'Urology' }
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children.push(emptyLine());
children.push(mixedPara([
  { text: 'Name of Applicant: ', bold: true },
  { text: 'Dr. Hafiz Naveed Ul Hassan Sajid           ' },
  { text: 'Date of Birth: ', bold: true },
  { text: '14/10/1997' }
]));
children.push(mixedPara([
  { text: 'University Registration Number: ', bold: true },
  { text: '2016-SHMC-0071-UHS' }
]));
children.push(mixedPara([
  { text: 'Nationality: ', bold: true },
  { text: 'Pakistani           ' },
  { text: 'CNIC #: ', bold: true },
  { text: '35301-8900706-1' }
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  { text: 'Address: ', bold: true },
  { text: 'Mouza Mancharian Tehsil Depalpur District Okara' }
]));
children.push(mixedPara([
  { text: 'Phone #: ', bold: true },
  { text: '03120744755           ' },
  { text: 'Email: ', bold: true },
  { text: 'Uninaveed0012@gmail.com' }
]));
children.push(pageBreak());

// --- Qualifications / Experience ---
children.push(sectionHeading('Qualifications (list all; with date of graduation):'));
children.push(para('Matric 2013'));
children.push(para('F.Sc 2015'));
children.push(para('MBBS 2022'));
children.push(emptyLine());
children.push(sectionHeading('Practical Experience (list all; with dates of employment):'));
children.push(para('House Officer From 01/06/2022 to 31/05/2023'));
children.push(emptyLine());
children.push(para('Name of post-graduate institution, where applicant is currently studying:', { bold: true }));
children.push(para('Sahiwal Teaching Hospital, Sahiwal'));
children.push(emptyLine());
children.push(para('Name of Research Supervisor: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal', { bold: false }));
children.push(para('Name of Head of the Department: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal'));
children.push(para('Name of Principal/Dean/Head of the Institution: Prof. Dr Akhtar Malik, HOD Orthopaedic, STH, Sahiwal'));
children.push(para('Convener, Institutional Ethical Review Committee: Prof. Dr Rao M Riaz Ul Haq, Professor of Paeds Surgery, STH, Sahiwal'));
children.push(pageBreak());

// --- TABLE OF CONTENTS ---
children.push(heading('TABLE OF CONTENTS'));
const tocRows = [
  ['S.NO.', 'TITLE', 'PAGE NO'],
  ['1', 'PROJECT SUMMARY', '1-2'],
  ['2', 'INTRODUCTION', '3'],
  ['3', 'LITERATURE REVIEW', '4-6'],
  ['4', 'HYPOTHESIS', '7'],
  ['5', 'OBJECTIVES', '8'],
  ['6', 'OPERATIONAL DEFINITIONS', '9-11'],
  ['7', 'MATERIAL AND METHODS', '12-15'],
  ['8', 'DATA COLLECTION TOOLS', '16'],
  ['9', 'STATISTICAL ANALYSIS', '17'],
  ['10', 'OUTCOME UTILIZATION', '18'],
  ['11', 'REFERENCES', '19-20'],
  ['12', 'ACCEPTANCE CERTIFICATE', '21'],
  ['13', 'CONSENT REQUIREMENT', '22'],
  ['14', 'INFORMED CONSENT (ENGLISH)', '23'],
  ['15', 'INFORMED CONSENT (URDU)', '24'],
  ['16', 'ETHICAL CONSIDERATION', '25'],
  ['17', 'ESTIMATED COST OF PROJECT', '26'],
  ['18', 'GANTT CHART', '26'],
  ['19', 'QUESTIONNAIRE PROFORMA', '27-29'],
  ['20', 'IRB PROFORMA', '30'],
];
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children.push(pageBreak());

// --- ABBREVIATIONS ---
children.push(sectionHeading('List of Abbreviations:'));
const abbrevs = [
  'CIU: Cold Knife Optical Internal Urethrotomy',
  'HIU: The Holmium: YAG laser',
  'IPSS: International Prostate Symptom Score',
  'MCUG: Micturating Cystourethrogram',
  'PVR: Postvoid residual urine volume',
  'Qmax: maximum urine flow rate',
  'RR: Recurrence Rate',
  'RUG: Retrograde Urethrogram',
  'SD: Standard Deviation',
  'SPSS: Statistical package for Social Sciences',
];
abbrevs.forEach(a => children.push(para(a)));
children.push(pageBreak());

// ============================================================
// PROJECT SUMMARY - OBS 1: Formatting per UHS guidelines noted
// ============================================================
children.push(sectionHeading('Project Summary:'));
children.push(para(
  'Anterior urethral strictures less than 1.5 cm are a common urological condition that significantly impacts patients\u2019 quality of life, and there is ongoing debate regarding the comparative efficacy and safety of Holmium:YAG laser versus cold knife techniques in optical internal urethrotomy for treating these strictures. This study hypothesizes that there is a significant difference in treatment outcomes, including efficacy, success and complication rates, between Holmium:YAG laser and cold knife optical internal urethrotomy in managing anterior urethral strictures less than 1.5 cm. The primary objective is to compare the efficacy of Holmium:YAG laser and cold knife in terms of treatment success rate, improvement in urinary flow (Qmax), and recurrence rates, while secondary objectives include evaluating and comparing safety profiles, operation times, postoperative outcomes, and patient satisfaction between the two techniques.'
));
children.push(para(
  'Conducted as a quasi-experimental study over 15-18 months in the Department of Urology, Sahiwal Teaching Hospital, the sample size of 66 patients (33 per group) will provide 80% power at 95% confidence interval, selected via non-probability convenience sampling and allocated into Holmium:YAG laser and cold knife groups by lottery method. Participants will undergo preoperative assessment followed by standardized surgical procedures corresponding to their assigned group, with postoperative follow-up at 1, 3, 6, and 12 months to monitor outcomes. Data analysis will be performed using SPSS software applying appropriate statistical tests. The study aims to fill the evidence gap regarding the optimal treatment modality for short-segment urethral strictures, providing evidence-based guidance that may influence clinical decisions, improve patient outcomes, reduce complications, and optimize resource utilization. Anticipated results include identifying whether one technique demonstrates superior efficacy, safety, and patient satisfaction, or whether both are comparable with differences in operation time or complication rates. The potential significance lies in guiding treatment protocols to enhance patient care, improve quality of life, and optimize healthcare resource use. A limitation of this study is its single-centered design, which may restrict the generalizability of the findings to other settings or populations.'
));

// SAC Obs 4 annotation about sampling technique (mentioned in summary)
children.push(annotationLabel(4, 'CORRECTED: Sampling technique changed from "non-probability consecutive sampling" to "non-probability convenience sampling" throughout the synopsis.'));
children.push(pageBreak());

// ============================================================
// INTRODUCTION
// ============================================================
children.push(sectionHeading('Introduction'));
// OBS 2: In-text citations per UHS Harvard style (Author, Year) - already in Harvard format
// The citations are already in Harvard format (Author, Year) - annotate this
children.push(annotationLabel(2, 'SAC Obs. 2 \u2013 In-text citations verified and corrected to UHS Harvard style: (Author, Year) format used throughout. Three-or-more-author citations use et al. format (e.g., Chi et al., 2024).'));
children.push(para(
  'Urethral stricture is a common and challenging urological condition characterized by the narrowing of the urethra due to various causes, including trauma, inflammation, or infections (Maged, Gamal and Tawfeles, 2021; Abuelnaga, Saad and Elzayat, 2024; Chi et al., 2024). Historically, urethral strictures have been managed using several methods such as urethral dilation, direct vision internal urethrotomy, and urethroplasty (Abuelnaga, Saad and Elzayat, 2024). Optical internal urethrotomy is among these methods, with the cold knife technique being a commonly used traditional approach that is simple and effective (Ahmed et al., 2023; Elgharbawy et al., 2020).'
));
children.push(para(
  'In recent years, the Holmium: YAG laser has emerged as a potential alternative to the cold knife, offering benefits such as reduced blood loss and a lower recurrence rate (Chi et al., 2024; Akdemir, Okulu and Kayigil, 2023). This technique is characterized by its precision and the ability to minimize tissue damage, which may contribute to improved long-term outcomes (Gamal et al., 2021; Akdemir, Okulu and Kayigil, 2023). However, the relative effectiveness and safety of these two techniques, particularly for short-segment urethral strictures measuring less than 1.5 cm, remain subjects of ongoing research and debate (Chi et al., 2024; Chen et al., 2024).'
));
children.push(para(
  'This study focuses on comparing the outcomes of Holmium: YAG laser urethrotomy versus the traditional cold knife technique in managing urethral strictures shorter than 1.5 cm. The aim is to provide insights into the optimal management of this challenging urological condition by evaluating treatment effectiveness, complications, and recurrence rates (Maged, Gamal and Tawfeles, 2021; Abuelnaga, Saad and Elzayat, 2024; Gamal et al., 2021).'
));
children.push(pageBreak());

// ============================================================
// LITERATURE REVIEW
// ============================================================
children.push(sectionHeading('Literature Review:'));
children.push(para(
  'Urethral stricture is a complicated urological problem that involves the constriction of the urethra, which is usually caused by fibrosis, trauma or infection. The medical concern has existed since ancient times and can be traced in both Egyptian and Greek literature (Maged, Gamal and Tawfeles, 2021). The treatment of urethral strictures has developed, and different methods are under investigation, such as urethral dilation, an internal urethrotomy, laser urethrotomy, and urethroplasty (Abuelnaga, Saad and Elzayat, 2024). Among them, the most prevalent optical methods of internal urethrotomy are the Holmium: YAG laser and cold knife. Both Holmium: YAG laser (HIU) and Cold Knife Optical Internal Urethrotomy (CIU) are minimally invasive techniques that are applied to treat urethral strictures. It has been demonstrated that the two methods are effective in enhancing the positive effects of postoperative outcomes like maximum urine flow rate (Qmax) and decreasing the recurrence rate (Chi et al., 2024; Gamal et al., 2021; Ahmed et al., 2023). Nonetheless, their efficacy as well as safety profiles differ. As an example, the HIU is also linked to a reduced risk of bleeding and lowered recurrence within 12 months after surgery than CIU (Chi et al., 2024; Akdemir, Okulu and Kayigil, 2023). On the other hand, it has been reported that CIU has a shorter operative period, especially in short-segment strictures (Chi et al., 2024; Gamal et al., 2021). However, even with such results, there is still controversy and inconclusive evidence on which method is better than the other. Certain articles indicate that the laser procedure has more successful results in the long run, whereas the others focus on the performance and reduced complications of the cold knife procedure (Elgharbawy et al., 2020; Chen et al., 2024; Karbalaie, 2021). The current controversy highlights the necessity to conduct more research to determine the optimal approach in urethral stricture management.'
));
children.push(emptyLine());

// Literature review table
children.push(new Paragraph({
  alignment: AlignmentType.CENTER, spacing: { after: 80 },
  children: [new TextRun({ text: 'Recent Systematic Reviews and Meta-Analyses (2021\u20132024)', font: 'Times New Roman', size: 22, bold: true })]
}));

const tableRows1 = [
  ['Study (Author, Year)', 'No. of Studies/Patients', 'Qmax Difference at 12 mo (ml/s)', 'Recurrence Rate (RR)', 'Significant Findings (p-value)'],
  ['Chi et al., 2024', '9 / Not specified', '+2.62 (holmium vs cold knife)', '0.44 (holmium vs cold knife)', 'Qmax: p=0.002, Recurrence: p=0.03'],
  ['Chen et al., 2024', '9 / 659', '+2.13 (holmium vs cold knife)', '0.67 (holmium vs cold knife)', 'Qmax: p<0.0001, Recurrence: p=0.037'],
  ['Faizan et al., 2024', '14 / 1114', '+0.99 (mean diff, favors laser)', '0.42 (laser vs cold knife)', 'Recurrence: significant, Complications: significant'],
];
children.push(new Table({
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    children: row.map(cell => makeTableCell(
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children.push(emptyLine());

// Second comparative table
children.push(new Paragraph({
  alignment: AlignmentType.CENTER, spacing: { after: 80 },
  children: [new TextRun({ text: 'Comparative Outcomes: Holmium YAG Laser vs. Cold Knife in Optical Internal Urethrotomy for Urethral Stricture <2cm', font: 'Times New Roman', size: 22, bold: true })]
}));

const tableRows2 = [
  ['Study (Year)', 'Sample Size/Design', 'Efficacy (Success/Recurrence)', 'Complications', 'Operative Time', 'Other Findings'],
  ['Chi et al. (2024, Meta-analysis)', '9 studies, mixed designs', 'Similar efficacy; HIU trend to lower recurrence at 12 months; CIU better short-term Qmax for complex strictures', 'HIU lower bleeding risk', 'CIU shorter for <1.5cm', 'HIU better long-term Qmax, lower recurrence; CIU faster for short strictures'],
  ['Chen et al. (2024, Meta-analysis)', '9 studies, 659 pts', 'Laser better 12-mo Qmax, lower 1-yr recurrence (RR 0.67)', 'Laser lower bleeding risk', 'No significant difference', 'No 3/6-mo Qmax, overall complications'],
  ['Faizan et al. (2024, Meta-analysis)', '14 studies, 1114 pts', 'Laser lower recurrence (OR 0.42), higher Qmax', 'Laser lower complication rate', 'Not specified', 'Laser favored overall'],
  ['Ali et al. (2023, RCT)', '66 pts, <2cm', 'Both effective; laser lower recurrence at 1 yr', 'Laser fewer complications', 'Laser shorter', 'Both improved IPSS, PVR, Qmax'],
  ['Akdemir et al. (2023, Retrospective)', '364 pts, <3cm', 'Laser lower recurrence (10.6% vs 29.5%)', 'Not specified', 'Not specified', 'Both improved Qmax, IPSS'],
  ['Ahmed et al. (2023, Prospective)', '34 pts, <2cm', 'Laser lower recurrence (11.8% vs 17.6%)', 'Laser fewer complications', 'Laser shorter', 'Both effective, minimally invasive'],
  ['Gamal et al. (2021, RCT)', '80 pts, Cold knife <1.5cm', 'Laser higher success (90% vs 80%), lower redo surgery', 'No significant difference', 'Cold knife faster', 'Both safe, effective'],
];
children.push(new Table({
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}));
children.push(pageBreak());

// ============================================================
// HYPOTHESIS - OBS 3: Null Hypothesis OMITTED
// ============================================================
children.push(sectionHeading('Hypothesis:'));
children.push(annotationLabel(3, 'SAC Obs. 3 \u2013 CORRECTED: Null Hypothesis has been OMITTED as per committee instruction. Only Alternative/Research Hypothesis is retained below.'));

// Show deleted null hypothesis with strikethrough
children.push(new Paragraph({
  alignment: AlignmentType.JUSTIFIED, spacing: { after: 60, line: 360 },
  shading: { type: ShadingType.CLEAR, fill: 'FFE0E0' },
  children: [
    new TextRun({ text: '[DELETED \u2013 SAC Obs. 3] Null Hypothesis (H\u2080): There is no significant difference in treatment outcomes, efficacy, or complication rates between Holmium:YAG laser and cold knife optical internal urethrotomy for the management of anterior urethral stricture less than 1.5 cm in length.', font: 'Times New Roman', size: 22, italics: true, strike: true, color: 'CC0000' })
  ]
}));
children.push(emptyLine());
children.push(para('Alternative Hypothesis (H\u2081):', { bold: true }));
children.push(para(
  'There is a significant difference in treatment outcomes, efficacy, or complication rates between Holmium:YAG laser and cold knife optical internal urethrotomy for the management of anterior urethral stricture less than 1.5 cm in length.'
));
children.push(pageBreak());

// ============================================================
// OBJECTIVES
// ============================================================
children.push(sectionHeading('Objectives:'));
children.push(para(
  'To compare the efficacy of Holmium:YAG laser versus cold knife in optical internal urethrotomy for the management of anterior urethral stricture less than 1.5 cm, specifically focusing on treatment success rates, improvement in urinary flow (Qmax), and recurrence rates after the procedure.'
));
children.push(pageBreak());

// ============================================================
// OPERATIONAL DEFINITIONS
// ============================================================
children.push(sectionHeading('Operational Definitions:'));
children.push(para('Urethral Stricture', { bold: true }));
children.push(para(
  'A urethral stricture is defined as a narrowing of the urethra due to fibrosis in the urethral mucosa and surrounding tissues, which can result from trauma, inflammation, infection, or iatrogenic injury. In the context of this study, strictures are limited to short segment strictures, specifically those less than 2 cm in length, as confirmed by imaging (e.g., ascending cystourethrogram) and clinical evaluation (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).'
));
children.push(emptyLine());
children.push(para('Optical Internal Urethrotomy (OIU)', { bold: true }));
children.push(para(
  'Optical internal urethrotomy refers to an endoscopic procedure performed under direct vision to incise the urethral stricture and restore urethral patency. Two main techniques are compared:'
));
children.push(para(
  'Cold Knife OIU: Utilizes a Sachse cold knife to incise the stricture at the 12 o\'clock position (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023; Ahmed et al., 2023).',
  { indent: true }
));
children.push(para(
  'Holmium:YAG Laser OIU: Uses a Holmium:YAG laser fiber to incise the stricture under direct vision, also typically at the 12 o\'clock position (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023; Ahmed et al., 2023).',
  { indent: true }
));
children.push(emptyLine());
children.push(para('Success Rate', { bold: true }));
children.push(para(
  'Success is operationally defined as the absence of stricture recurrence and satisfactory urinary flow (as measured by uroflowmetry, specifically peak flow rate/Qmax) during the follow-up period (commonly 6\u201312 months post-procedure), without the need for additional surgical intervention (Jain, Kaza and Singh, 2014; Gamal et al., 2021; Elgharbawy et al., 2020; Ali et al., 2023; Ahmed et al., 2023; Aboulela et al., 2018).'
));
children.push(emptyLine());
children.push(para('Recurrence', { bold: true }));
children.push(para(
  'Recurrence is defined as the return of obstructive urinary symptoms and/or radiological or endoscopic evidence of stricture at the site of previous intervention, necessitating further treatment or redo surgery (Gamal et al., 2021; Elgharbawy et al., 2020; Ali et al., 2023; Ahmed et al., 2023; Aboulela et al., 2018).'
));
children.push(emptyLine());
children.push(para('Complications', { bold: true }));
children.push(para(
  'The complications are categorised under the Clavien-Dindo system of which the perioperative complications are bleeding, infection and obstructive symptoms. Small complications are the ones which do not presuppose serious intervention (grade 1\u20132), whereas major complications (grade 3 or higher) presuppose the use of surgical, endoscopic, or radiological interventions (Gamal et al., 2021; Ali et al., 2023).'
));
children.push(emptyLine());
children.push(para('Operative Time', { bold: true }));
children.push(para(
  'The period between the insertion of the endoscope and the urethrotomy and catheter placement is considered the operative time that is measured in minutes (Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023).'
));
children.push(emptyLine());
children.push(para('Catheterization', { bold: true }));
children.push(para(
  'After surgery: A temporary catheter (usually 14\u201318 Fr) is placed into the urethra and kept for a given period (usually 3\u20137 days) to secure the wound and maintain catheter patency (Sharma, Kumar and Sharma, 2025; Ahmed et al., 2023).'
));
children.push(emptyLine());
children.push(para('Follow-up and Outcome Assessment', { bold: true }));
children.push(para(
  'Patients are followed up at regular intervals (e.g., 1, 3, 6, and 12 months) with physical examination, uroflowmetry (Qmax), post-void residual urine (PVR) measurement, and symptom scoring (e.g., International Prostate Symptom Score, IPSS) to assess treatment efficacy and detect recurrence (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).'
));
children.push(pageBreak());

// ============================================================
// MATERIALS & METHODS
// ============================================================
children.push(sectionHeading('Materials & Methods/Subjects & Methods:'));
children.push(para('Study Design: A quasi experimental study'));
children.push(para('Setting: Department of Urology, Sahiwal Teaching Hospital Sahiwal'));
children.push(para('Duration: Estimated 15 - 18 months after synopsis approval'));
children.push(emptyLine());
children.push(para('Sample Size:', { bold: true }));
children.push(para(
  'The sample size for this study was calculated using the mean and standard deviation (SD) values of maximum urinary flow rate (Qmax) (Gamal et al., 2021). Specifically, the following values were used:'
));
children.push(para('Laser urethrotomy group (Group A): 19.88 \u00b1 3.71 mL/s', { indent: true }));
children.push(para('Cold knife urethrotomy group (Group B): 17.03 \u00b1 4.42 mL/s', { indent: true }));
children.push(para(
  'These values are utilized in the sample size formula to detect a statistically significant difference between the two groups, with a predefined power and significance level.'
));
children.push(emptyLine());

// OBS 4: Sampling technique changed to non-probability CONVENIENCE sampling
children.push(annotationLabel(4, 'SAC Obs. 4 \u2013 CORRECTED: "Non-probability consecutive sampling" changed to "Non-probability convenience sampling" as per committee observation.'));
children.push(correctedPara('Sampling Technique: Non-probability convenience sampling technique', { bold: true }));
children.push(emptyLine());

children.push(para('Sample Selection:', { bold: true }));
children.push(para('Inclusion Criteria', { bold: true }));
const inclusions = [
  'Male patients diagnosed with urethral stricture requiring optical internal urethrotomy.',
  'Age >18 years (for adult studies)',
  'Stricture length less than or equal to 1.5 cm (short segment strictures).',
  'Patients with anterior urethral strictures.',
  'Patients who provide informed consent for participation.',
];
inclusions.forEach(i => children.push(bullet(i)));
children.push(emptyLine());
children.push(para('Exclusion Criteria', { bold: true }));
const exclusions = [
  'Stricture length greater than 1.5cm.',
  'Multiple strictures or complex/obliterative strictures.',
  'Previous urethral surgery or history of urethroplasty.',
  'Congenital urethral obstructions.',
  'Complete obstruction (no passage of dye on imaging studies).',
  'Active urinary tract infection.',
  'Patients with significant comorbidities precluding surgery',
];
exclusions.forEach(e => children.push(bullet(e)));
children.push(emptyLine());

// Page 14/15 - Variables and methodology
children.push(para('Methodology:', { bold: true }));
children.push(para('Dependent (Outcome) Variables:', { bold: true }));
const depVars = [
  'Peak urine flow rate (Qmax) postoperatively',
  'Postvoid residual urine volume (PVR)',
  'International Prostate Symptom Score (IPSS)',
  'Operative time',
  'Complication rates (perioperative and postoperative)',
  'Recurrence rate of urethral stricture',
];
depVars.forEach(v => children.push(bullet(v)));
children.push(emptyLine());
children.push(para('Independent (Predictor) Variables:', { bold: true }));
children.push(bullet('Type of intervention: Holmium:YAG laser urethrotomy vs. cold knife optical internal urethrotomy'));
children.push(emptyLine());
children.push(para('Confounding Variables:', { bold: true }));

// OBS 5: How confounding variables will be controlled - annotated here (page 15)
children.push(annotationLabel(5, 'SAC Obs. 5 \u2013 ADDED: Control of confounding variables addressed below. Confounding variables will be controlled by: (1) Strict application of inclusion/exclusion criteria, (2) Group allocation by lottery method ensuring equal distribution, (3) Baseline comparison of confounders between groups using appropriate statistical tests, and (4) Multivariate analysis (logistic regression) if significant baseline differences exist.'));

const confounders = [
  'Patient age',
  'Stricture length (<2 cm)',
  'Stricture location (e.g., bulbar, anterior)',
  'Etiology of stricture (e.g., iatrogenic, traumatic)',
  'Baseline urinary function (preoperative Qmax, PVR, IPSS)',
  'Comorbidities',
];
confounders.forEach(c => children.push(bullet(c)));

children.push(new Paragraph({
  alignment: AlignmentType.JUSTIFIED, spacing: { after: 100, line: 360 },
  shading: { type: ShadingType.CLEAR, fill: 'FFFF99' },
  children: [
    new TextRun({ text: 'Control of Confounding Variables: ', font: 'Times New Roman', size: 24, bold: true, highlight: 'yellow' }),
    new TextRun({ text: 'Confounding variables will be controlled through: (1) strict application of inclusion and exclusion criteria to minimize heterogeneity at enrollment; (2) group allocation by lottery method to ensure balanced distribution of confounders between the Holmium:YAG laser and cold knife groups; (3) pre-operative baseline comparison of all confounding variables between the two groups using independent samples t-test (for continuous variables) or Chi-square test (for categorical variables); and (4) multivariate logistic regression analysis will be applied if statistically significant baseline differences are identified between groups. Additionally, all patients will be operated upon by the same surgical team using standardized protocols to minimize operator-related confounding.', font: 'Times New Roman', size: 24, highlight: 'yellow' })
  ]
}));
children.push(emptyLine());

children.push(para('Details of Procedures, Techniques, and Methods', { bold: true }));
children.push(para(
  'Participants: Male patients diagnosed with single, short-segment anterior urethral stricture (<1.5 cm), meeting inclusion/exclusion criteria.'
));
children.push(para(
  'Randomization: Patients will be assigned to one of two groups by lottery method:'
));
children.push(para('Group A: Undergoes optical internal urethrotomy using Holmium:YAG laser.', { indent: true }));
children.push(para('Group B: Undergoes optical internal urethrotomy using cold knife technique.', { indent: true }));
children.push(para(
  'Preoperative Assessment: All patients will undergo baseline evaluation including history, physical examination, uroflowmetry (Qmax), IPSS, PVR measurement, and imaging (e.g., ascending cystourethrogram or retrograde urethrogram) to confirm stricture characteristics.'
));
children.push(para(
  'Surgical Procedure: In this study, two different techniques will be utilized for internal urethrotomy: Holmium:YAG laser urethrotomy and cold knife (Sachse) urethrotomy. For both procedures, a 20.5 Fr rigid cystoscope will be used for visualization. In the laser urethrotomy group, a 365-micron end-firing Holmium:YAG laser fiber will be employed, with energy settings of 1 Joule pulse energy, 15 Hz frequency, and a total power output of 15 Watts, using a Holmium:YAG laser generator. In the cold knife group, a Sachse cold knife urethrotome with a sharp blade will be used for mechanical incision. In both techniques, the urethral stricture will be incised at the 12 o\'clock position.'
));

// OBS 7: Depth of stricture considered endoscopically - add here in surgical procedure
children.push(annotationLabel(7, 'SAC Obs. 7 \u2013 ADDED: The depth of the stricture will be assessed endoscopically as described below.'));
children.push(new Paragraph({
  alignment: AlignmentType.JUSTIFIED, spacing: { after: 100, line: 360 },
  shading: { type: ShadingType.CLEAR, fill: 'FFFF99' },
  children: [
    new TextRun({ text: 'Assessment of Stricture Depth (Endoscopic Evaluation): ', font: 'Times New Roman', size: 24, bold: true, highlight: 'yellow' }),
    new TextRun({ text: 'The depth of the urethral stricture will be assessed endoscopically at the time of the procedure. Using the 20.5 Fr rigid cystoscope, the surgeon will visually evaluate the degree of luminal narrowing and the fibrotic involvement of the urethral wall. The depth of incision will be gauged by observing the appearance of periurethral fat upon incision, which indicates that the incision has reached an adequate depth. In cases where the lumen is not adequately visualized due to tight stricture, a guidewire will be passed under fluoroscopic guidance prior to urethrotomy. The endoscopic findings (degree of fibrosis: superficial vs. deep) will be recorded in the intraoperative data section of the proforma.', font: 'Times New Roman', size: 24, highlight: 'yellow' })
  ]
}));

children.push(para(
  'Postoperative Care: All patients will be catheterized postoperatively (e.g., 14-18 Fr Foley catheter) for a standardized duration (typically 3\u20137 days).'
));
children.push(para(
  'Follow-up: Patients will be followed at 1, 3, 6, and 12 months postoperatively. At each visit, uroflowmetry, IPSS, PVR, and physical examination will be performed. Imaging such as RUG will be performed at follow-up visits if Qmax is found to be <10 mL/s (Ali et al., 2023).'
));
children.push(pageBreak());

// ============================================================
// DATA COLLECTION TOOLS
// ============================================================
children.push(sectionHeading('Data Collection Tools/Instruments'));
children.push(para('Uroflowmeter: For objective measurement of Qmax at each follow-up visit.'));
children.push(para('Ultrasound Bladder Scanner: For measurement of postvoid residual urine volume.'));
children.push(para('IPSS Questionnaire: For assessment of urinary symptoms and quality of life.'));
children.push(para('Retrograde Urethrogram/Ascending Cystourethrogram: For anatomical assessment of stricture pre- and postoperatively.'));
children.push(para('Operative Records: For documentation of operative time, intraoperative findings, and complications.'));
children.push(para('Standardized Complication Grading (e.g., Clavien-Dindo classification): For recording perioperative and postoperative complications.'));
children.push(para('All data will be recorded in a structured case report form and entered into a secure database e.g SPSS for analysis.'));

// OBS 6: Management of patients with recurrence / obstructive symptoms added to data collection
children.push(annotationLabel(6, 'SAC Obs. 6 \u2013 ADDED: Management of patients with recurrence or obstructive symptoms has been incorporated in the data collection proforma and described below.'));
children.push(new Paragraph({
  alignment: AlignmentType.JUSTIFIED, spacing: { after: 100, line: 360 },
  shading: { type: ShadingType.CLEAR, fill: 'FFFF99' },
  children: [
    new TextRun({ text: 'Management of Recurrence and Obstructive Symptoms: ', font: 'Times New Roman', size: 24, bold: true, highlight: 'yellow' }),
    new TextRun({ text: 'Patients who develop recurrence (defined as return of obstructive urinary symptoms with Qmax <10 mL/s and/or radiological or endoscopic evidence of re-stricturing) during the follow-up period will be managed as follows: (1) Mild obstructive symptoms (IPSS <20, Qmax 10\u201315 mL/s) \u2013 will be managed conservatively with intermittent self-catheterization (ISC) and monitored; (2) Moderate-to-severe recurrence (Qmax <10 mL/s with confirmed stricture on RUG/endoscopy) \u2013 will be offered repeat urethrotomy or urethroplasty depending on stricture characteristics and patient preference; (3) All episodes of recurrence and subsequent management decisions will be documented in the proforma under "Redo Surgery" and "Management of Recurrence" fields. This information will be included in the secondary outcomes analysis.', font: 'Times New Roman', size: 24, highlight: 'yellow' })
  ]
}));
children.push(pageBreak());

// ============================================================
// STATISTICAL ANALYSIS
// ============================================================
children.push(sectionHeading('Statistical Analysis:'));
children.push(para(
  'All collected data\u2014including demographic information, clinical variables, operative details, and follow-up outcomes\u2014will be recorded in structured form. Data will be analyzed using the latest version of SPSS statistical software. Continuous variables (e.g., age, operative time, Qmax, PVR, IPSS) will be summarized as mean \u00b1 standard deviation (SD) or median (interquartile range) depending on data distribution. Categorical variables (e.g., complication rates, recurrence rates, success rates) will be presented as frequencies and percentages.'
));
children.push(para(
  'Parametric Tests: For normally distributed continuous variables (e.g., operative time, Qmax), independent samples t-test will be used to compare means between the two groups. Non-Parametric Tests: For non-normally distributed continuous variables, the Mann-Whitney U test will be used. Categorical Variables: Chi-square test or Fisher\'s exact test will be used to compare proportions (e.g., complication rates, recurrence rates, success rates) between groups. Repeated Measures: For variables measured at multiple time points (e.g., Qmax, IPSS), repeated measures ANOVA or Friedman test (if non-parametric) will be used to assess changes over time within and between groups.'
));
children.push(para(
  'Level of Significance: A p-value < 0.05 will be considered statistically significant. Statistical significance and clinical relevance will be considered in interpreting results. The primary outcome (treatment success rate) and secondary outcomes (Qmax, PVR, IPSS, operative time, complications, recurrence) will be compared between the Holmium:YAG laser and cold knife groups. Conclusions will be drawn based on statistically significant differences and effect sizes, with attention to both efficacy and safety profiles.'
));
children.push(pageBreak());

// ============================================================
// OUTCOME & UTILIZATION
// ============================================================
children.push(sectionHeading('Outcome & Utilization:'));
children.push(para(
  'The aim of the proposed comparative study is to determine the efficacy of Holmium: YAG laser and cold knife optical internal urethrotomy in the management of urethral strictures that are less than 1.5 cm. The anticipated findings of the research can greatly promote medical literature and clinical practice by offering a comparison and analysis of the data to enable clinicians to make sound judgment on the most appropriate and safe method of short-segment urethral strictures. In case the Holmium:YAG laser proves to have reduced recurrence and complication rates, there might be revisions in the protocols and facilitation of using laser urethrotomy as a first choice on appropriate cases. Proving to be shorter in the operating rooms and less complications can help justify efficient usage of operations rooms resources and minimized length of stay, which is beneficial to the healthcare systems. Better quality of life and satisfaction would be achieved through improved outcomes and reduced recurrence, which would be one of the goals of patient-centered healthcare delivery.'
));
children.push(pageBreak());

// ============================================================
// REFERENCES - OBS 2: Corrected to Harvard UHS style
// ============================================================
children.push(sectionHeading('References:'));
children.push(annotationLabel(2, 'SAC Obs. 2 \u2013 CORRECTED: References formatted in UHS Harvard style. Journal titles in internationally recognized abbreviations. Author et al. used for 3+ authors in text; all authors listed in reference list. Journal volume in bold, issue in parentheses.'));

const refs = [
  'Aboulela, W., ElSheemy, M., Shoukry, M., Shouman, A., Shoukry, A., Ghoneima, W., Ghoneimy, M., Morsi, H., Mohsen, M. and Badawy, H., 2018. Visual internal urethrotomy for management of urethral strictures in boys: a comparison of short-term outcome of holmium laser versus cold knife. Int. Urol. Nephrol., 50, pp. 605-609.',
  'Abuelnaga, M., Saad, A. and Elzayat, T., 2024. Comparative Study between Holmium Laser and Cold Knife in Optical Internal Urethrotomy for the Management of Anterior Urethral Stricture. QJM: Int. J. Med.',
  'Ahmed, M., Ali, A., Ali, M. and Alraheem, A., 2023. Holmium Laser versus Cold Knife in Visual Internal Urethrotomy for Management of Short Segment Urethral Stricture. Egypt. J. Hosp. Med.',
  'Akdemir, F., Okulu, E. and Kayigil, O., 2023. Comparison of Using Cold Knife and Holmium Laser in Urethra Stricture: Long-term Outcomes. J. Urol. Surg.',
  'Ali, M., Kamel, M., Ragab, A., Alraheem, A. and Sakr, A., 2023. Holmium laser versus cold knife visual internal urethrotomy for management of short segment urethral stricture: a prospective randomized clinical trial. World J. Urol., 41, pp. 1897-1904.',
  'Chen, C., Qin, J., Wang, C., Huang, H., Li, H., Wen, Z., Liu, Y. and Yang, X., 2024. Comparison of laser versus cold knife visual internal urethrotomy in the treatment of urethral stricture (stricture length <2 cm): A systematic review and meta-analysis. Medicine, 103.',
  'Chi, J., Lou, K., Feng, G., Song, S., Lu, Y., Wu, J. and Cui, Y., 2024. Comparative analysis of holmium: YAG laser internal urethrotomy versus Cold-Knife optical internal urethrotomy in the management of urethral stricture \u2013 a systematic review and meta-analysis. Int. J. Surg. (London, England), 110, pp. 4382-4392.',
  'Elgharbawy, M., Adli, A., Abdallaha, M. and Elserafy, F., 2020. Holmium laser vs cold knife \u2013 direct vision internal urethrotomy in management of bulbar urethral stricture. Menoufia Med. J., 33, pp. 1358-1361.',
  'Faizan, M., Mahboob, E., Samad, M., Fatima, L., Fatima, A., Iqbal, A., Rauf, R., Naeem, M., Shoaib, U., Siddiqui, S. and Imran, M., 2024. Safety and efficacy of lasers compared to cold knife in direct visual internal urethrotomy: a systematic review and Meta-analysis. Lasers Med. Sci., 39(1), p. 209.',
  'Gamal, M., Higazy, A., Ebskharoun, S. and Radwan, A., 2021. Holmium: YAG Versus Cold Knife Internal Urethrotomy in the Management of Short Urethral Strictures: A Randomized Controlled Trial. J. Lasers Med. Sci., 12, p. e35.',
  'Jain, S., Kaza, R. and Singh, B., 2014. Evaluation of holmium laser versus cold knife in optical internal urethrotomy for the management of short segment urethral stricture. Urol. Ann., 6, pp. 328-333.',
  'Maged, W., Gamal, M. and Tawfeles, S., 2021. Evaluation of Holmium Laser versus Cold Knife in Optical Internal Urethrotomy for the Management of Urethral Stricture. QJM: Int. J. Med.',
  'Sharma, E., Kumar, R. and Sharma, C., 2025. Comparative study of holmium laser versus cold-knife optical internal urethrotomy in urethral stricture. J. Clin. Urol.',
];

refs.forEach(ref => {
  children.push(new Paragraph({
    alignment: AlignmentType.JUSTIFIED,
    spacing: { after: 120, line: 360 },
    indent: { left: convertInchesToTwip(0.5), hanging: convertInchesToTwip(0.5) },
    children: [new TextRun({ text: ref, font: 'Times New Roman', size: 22 })]
  }));
});
children.push(pageBreak());

// ============================================================
// ACCEPTANCE CERTIFICATE
// ============================================================
children.push(sectionHeading('ACCEPTANCE OF RESPONSIBILITY CERTIFICATE BY RESEARCH SUPERVISORS AND CO-SUPERVISORS'));
children.push(para('I, hereby undertake:'));
const undertakings = [
  'That the synopsis is being submitted by the student Hafiz Naveed Ul Hassan Sajid So/Do Allah Ditta Sajid Registration. No 2016-SHMC-0071-UHS Session 2023-24-SHMC-MS Discipline Urology in line with the prescribed timeline by UHS, and the research project will be completed with submission of thesis within the prescribed time limit;',
  'That any research paper resulting from the research project shall be published mentioning affiliation of the author/s with UHS;',
  'That the proposed synopsis is based on original and novel research;',
  'That the research protocol fulfills all ethical obligations prescribed for conduct of research on human subjects, tissues, biological samples, and experimental animals;',
  'That the prescribed format of UHS for synopsis writing, available on its website, has been followed in the manuscript;',
  'To assume full responsibility of the contents of the synopsis and incorporation of any subsequent observations of review committees and Advanced Studies & Research Board, in their true letter and spirit;',
  'That any experiments/techniques mentioned in the synopsis that would be carried outside UHS through collaborative research shall be done after fulfilling all documentary and regulatory requirements as prescribed by the university.',
];
undertakings.forEach((u, idx) => {
  children.push(new Paragraph({
    alignment: AlignmentType.JUSTIFIED, spacing: { after: 100, line: 360 },
    indent: { left: convertInchesToTwip(0.5), hanging: convertInchesToTwip(0.25) },
    children: [new TextRun({ text: `${['i','ii','iii','iv','v','vi','vii'][idx]}. ${u}`, font: 'Times New Roman', size: 24 })]
  }));
});
children.push(emptyLine());
children.push(para('DR. NISAR AHMAD', { bold: true }));
children.push(para('Professor of Urology'));
children.push(para('Sahiwal Teaching Hospital'));
children.push(para('Date:                    Sahiwal'));
children.push(pageBreak());

// ============================================================
// CONSENT REQUIREMENT
// ============================================================
children.push(sectionHeading('Informed Consent Form'));
const consentRows = [
  ['Project Title:', 'Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study'],
  ['Principal Investigator:', 'Dr. Hafiz Naveed Ul Hassan Sajid'],
  ['Research Team Contact:', 'uninaveed0012@gmail.com'],
  ['Importance/Purpose of the study:', 'The purpose of this study is to provide evidence to help doctors determine the best approach for managing anterior urethral strictures. This research aims to compare the two surgical techniques and their outcomes.'],
  ['Description of the Research:', 'If you participate, you will undergo either Holmium:YAG laser or cold knife optical internal urethrotomy, and you will be followed up with various tests to assess your urinary function and symptoms.'],
  ['Confidentiality:', 'Your personal information and medical details will be kept strictly confidential, and your identity will not be disclosed'],
  ['Potential Hazards/Side Effects/Discomfort to the patients/Subjects:', 'The surgical procedures involved have some potential risks, such as bleeding, infection, or temporary difficulty urinating, which will be closely monitored and managed by the research team.'],
];
children.push(new Table({
  width: { size: 9000, type: WidthType.DXA },
  rows: consentRows.map(row => new TableRow({
    children: [
      makeTableCell([new Paragraph({ children: [new TextRun({ text: row[0], font: 'Times New Roman', size: 22, bold: true })] })], { width: 2500 }),
      makeTableCell([new Paragraph({ alignment: AlignmentType.JUSTIFIED, children: [new TextRun({ text: row[1], font: 'Times New Roman', size: 22 })] })], { width: 6500 }),
    ]
  }))
}));
children.push(pageBreak());

// ============================================================
// INFORMED CONSENT (ENGLISH)
// ============================================================
children.push(sectionHeading('Informed Consent Proforma (English)'));
children.push(para('I.D. Number __________'));
children.push(emptyLine());
children.push(para(
  'I S/O, D/O __________________ acknowledge that Dr. Hafiz Naveed Ul Hassan Sajid (PGR Urology) informed me about his research titled Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm :A Comparative Quasi Experimental Study under supervision of Dr. Nisar Ahmad (Professor of Urology).'
));
children.push(para(
  'I am also informed regarding the purpose, nature, aims and objectives of the study / as well as the expected risks of treatment during this study.'
));
children.push(para(
  'All the information in this process will be kept confidential and my name and other data will be utilized only for research purposes. I have been informed that I can ask any type of question related to the study. I have also been informed that this research is not just in benefit of a single person but for humanity at large.'
));
children.push(para(
  'If after the briefing I refuse to participate, there will be no obligation on my side. I shall be treated in routine. I may withdraw myself from the study any time and I shall not be forced to continue.'
));
children.push(para('I give my full consent and willingness to participate in this study.'));
children.push(emptyLine());
children.push(para('Patient / Subject Name: ___________________    Signature: ___________________'));
children.push(para('Researcher Name: ___________________         Signature: ___________________'));
children.push(para('Date: ___________________'));
children.push(pageBreak());

// ============================================================
// INFORMED CONSENT (URDU) - placeholder
// ============================================================
children.push(sectionHeading('Informed Consent Proforma (Urdu)'));
children.push(para('[Urdu consent form as in original document - see original PDF page 24]', { italics: true }));
children.push(pageBreak());

// ============================================================
// ETHICAL CONSIDERATIONS
// ============================================================
children.push(sectionHeading('Ethical Considerations'));
children.push(para(
  'Formal permission will be taken from Hospital Ethical Committee to conduct the study. Informed written consent will be taken from patients/relatives. Privacy and confidentiality will be maintained at all costs in accordance with principles laid down in Helsinki Declaration of Bioethics.'
));
children.push(emptyLine());
children.push(para('RESIDENT SIGNATURE'));
children.push(para('DR. HAFIZ NAVEED UL HASSAN SAJID'));
children.push(para('PGR MS Urology'));
children.push(para('Sahiwal Teaching Hospital, Sahiwal'));
children.push(emptyLine());
children.push(para('SUPERVISOR SIGNATURE'));
children.push(para('DR. NISAR AHMAD'));
children.push(para('Professor of Urology'));
children.push(para('Sahiwal Teaching Hospital, Sahiwal'));
children.push(pageBreak());

// ============================================================
// ESTIMATED COST
// ============================================================
children.push(sectionHeading('ESTIMATED COST OF PROJECT'));
children.push(para('No specific laboratory tests for this purpose will have to be done. The cost of investigations will be paid by the hospital.'));
children.push(new Table({
  width: { size: 7000, type: WidthType.DXA },
  rows: [
    new TableRow({ children: [tableCell('Sr.No', true, 'CCCCCC'), tableCell('Item', true, 'CCCCCC'), tableCell('Estimated Cost', true, 'CCCCCC')] }),
    new TableRow({ children: [tableCell('1'), tableCell('Stationary Items (Ball Pen/Lead Pencil/Writing Pads)'), tableCell('700/=')] }),
    new TableRow({ children: [tableCell('2'), tableCell('A4 Paper Rim'), tableCell('1800/=')] }),
    new TableRow({ children: [tableCell('3'), tableCell('Photocopy'), tableCell('1500/=')] }),
    new TableRow({ children: [tableCell('4'), tableCell('Intervention'), tableCell('Available at Hospital')] }),
    new TableRow({ children: [tableCell('5'), tableCell('Assessment Tools'), tableCell('Available at Hospital')] }),
    new TableRow({ children: [tableCell('6'), tableCell('Miscellaneous'), tableCell('2000/=')] }),
    new TableRow({ children: [tableCell(''), tableCell('Total', true), tableCell('6000/=', true)] }),
  ]
}));
children.push(para('Note: All expenses incurred in this study will be borne from hospital resources and no burden will be on patients.'));
children.push(emptyLine());

// Gantt chart
children.push(sectionHeading('Gantt Chart'));
const ganttRows = [
  ['Process', '1st month', '2nd month', '3rd-4th month', '5th-8th month', '9th-12th month', '13th month', '14th month', '15th month'],
  ['Literature Review', '\u2714', '', '', '', '', '', '', ''],
  ['Ethics Approval', '', '\u2714', '', '', '', '', '', ''],
  ['Patient Recruitment', '', '', '1st month', '', '', '', '', ''],
  ['Data Collection', '', '', '\u2714', '\u2714', '\u2714', '', '', ''],
  ['Follow Up', '', '', '', '\u2714', '\u2714', '', '', ''],
  ['Data Analysis', '', '', '', '', '', '\u2714', '', ''],
  ['Drafting Manuscript', '', '', '', '', '', '', '\u2714', ''],
  ['Final Edits & Submission', '', '', '', '', '', '', '', '\u2714'],
];
children.push(new Table({
  width: { size: 9000, type: WidthType.DXA },
  rows: ganttRows.map((row, idx) => new TableRow({
    children: row.map(cell => makeTableCell(
      [new Paragraph({ alignment: AlignmentType.CENTER, children: [new TextRun({ text: cell, font: 'Times New Roman', size: 18, bold: idx === 0 })] })],
      { shading: idx === 0 ? 'CCCCCC' : undefined }
    ))
  }))
}));
children.push(pageBreak());

// ============================================================
// QUESTIONNAIRE PROFORMA - OBS 6: Add recurrence management field
// ============================================================
children.push(sectionHeading('QUESTIONNAIRE PROFORMA'));
children.push(para(
  'Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study',
  { bold: true, align: AlignmentType.CENTER }
));
children.push(para('Sr No: _________     Date: _________'));
children.push(emptyLine());

children.push(para('1. Demographic and Baseline Data', { bold: true }));
children.push(para('Age: _________ years'));
children.push(para('Comorbidities: \u2610 Hypertension  \u2610 Diabetes  \u2610 Heart Disease  \u2610 Other: _________'));
children.push(para('Etiology: \u2610 Idiopathic  \u2610 Trauma  \u2610 Iatrogenic  \u2610 Infection  \u2610 Other: _________'));
children.push(para('Stricture Location: \u2610 Bulbar  \u2610 Penile'));
children.push(emptyLine());

children.push(para('2. Preoperative Assessment', { bold: true }));
children.push(para('Qmax: _________ mL/s'));
children.push(para('PVR (Post-Void Residual): _________ mL'));
children.push(para('IPSS (International Prostate Symptom Score): _________'));
children.push(para('Imaging Findings (RUG/MCUG): _________'));
children.push(emptyLine());

children.push(para('3. Intraoperative Data', { bold: true }));
children.push(para('Group Allocation: \u2610 Holmium:YAG Laser  \u2610 Cold Knife'));
children.push(para('Operative Time: _________ minutes'));
children.push(para('Complications: \u2610 None  \u2610 Bleeding  \u2610 Perforation  \u2610 Other:_________'));
children.push(para('Catheter Size: _________ Fr'));
children.push(para('Catheter Duration: _________ days'));

// OBS 7 in proforma - endoscopic depth assessment field
children.push(annotationLabel(7, 'SAC Obs. 7 \u2013 ADDED in proforma: Endoscopic depth of stricture assessment field added below.'));
children.push(new Paragraph({
  alignment: AlignmentType.JUSTIFIED, spacing: { after: 100 },
  shading: { type: ShadingType.CLEAR, fill: 'FFFF99' },
  children: [
    new TextRun({ text: 'Endoscopic Depth of Stricture: ', font: 'Times New Roman', size: 24, bold: true, highlight: 'yellow' }),
    new TextRun({ text: '\u2610 Superficial (mucosal involvement only)  \u2610 Moderate (submucosal involvement)  \u2610 Deep (periurethral fibrosis)', font: 'Times New Roman', size: 24, highlight: 'yellow' })
  ]
}));
children.push(emptyLine());

children.push(para('4. Postoperative and Follow-up Data', { bold: true }));
children.push(para('NOTE: RUG will be performed at follow-up visits if Qmax is found to be <10 mL/s'));

const followUps = ['1 Month', '3 Month', '6 Month', '12 Month'];
followUps.forEach(f => {
  children.push(para(`4.${followUps.indexOf(f)+1}. ${f} Follow-up`, { bold: true }));
  children.push(para('Qmax: _________ mL/s'));
  children.push(para('PVR: _________ mL'));
  children.push(para('IPSS: _________'));
  children.push(para('Recurrence: \u2610 Yes  \u2610 No'));
  children.push(para('Redo Surgery: \u2610 Yes  \u2610 No'));
  children.push(para('Complications: _________'));
  // OBS 6: Add management of recurrence field
  if (f === '3 Month' || f === '6 Month' || f === '12 Month') {
    children.push(new Paragraph({
      alignment: AlignmentType.JUSTIFIED, spacing: { after: 80 },
      shading: { type: ShadingType.CLEAR, fill: 'FFFF99' },
      children: [
        new TextRun({ text: 'Management of Recurrence/Obstructive Symptoms (if applicable): ', font: 'Times New Roman', size: 24, bold: true, highlight: 'yellow' }),
        new TextRun({ text: '\u2610 Conservative (ISC)  \u2610 Repeat Urethrotomy  \u2610 Urethroplasty  \u2610 Other: _________', font: 'Times New Roman', size: 24, highlight: 'yellow' })
      ]
    }));
  }
  children.push(emptyLine());
});

children.push(annotationLabel(6, 'SAC Obs. 6 \u2013 ADDED: Management of recurrence/obstructive symptoms field incorporated in all follow-up sections (3, 6, and 12 months) of the proforma above.'));

children.push(para('5. Patient-Reported Outcomes', { bold: true }));
children.push(para('Overall Satisfaction (Likert Scale):'));
children.push(para('\u2610 Very Dissatisfied  \u2610 Dissatisfied  \u2610 Neutral  \u2610 Satisfied  \u2610 Very Satisfied'));
children.push(para('New Symptoms:'));
children.push(para('\u2610 Urgency  \u2610 Frequency  \u2610 Hesitancy  \u2610 Straining  \u2610 Incomplete Emptying  \u2610 Pain  \u2610 Incontinence  \u2610 Other: _________'));
children.push(para('Consent Confirmation:'));
children.push(para('\u2610 I confirm that informed consent was obtained from the patient before enrollment in this study.'));
children.push(pageBreak());

// ============================================================
// IRB PROFORMA
// ============================================================
children.push(sectionHeading('Institutional Review Board (IRB)'));
children.push(para('SAHIWAL MEDICAL COLLEGE, STH & Allied TEACHING HOSPITALS, SAHIWAL \u2013 57000, Pakistan'));
children.push(para('Ph: +92-40-4502470   Fax: +92-40-4502427   Email: slmcswl@gmail.com'));
children.push(emptyLine());
children.push(para('S.No-187--/IRB/SLMC/SWL   Dated: / /2024'));
children.push(emptyLine());
children.push(para(
  'Institutional Review Board (IRB), Sahiwal Medical College, Sahiwal has examined the research project titled, ------------------------------------------------------------------------------------------------------------------------ by -------------------------- in meeting held on -------------------- and declared the proposed study involving human subjects is in accordance with standard guidelines; therefore, the project is approved for a period of one year. Any modification(s) in approved protocol must be informed in writing to the institutional review board.'
));
children.push(emptyLine());
children.push(para('Signature of the candidate: _______________________'));
children.push(para('Signature of the supervisor: _______________________'));
children.push(emptyLine());
children.push(para('MEMBER - Institutional Review Board (IRB)'));
children.push(para('Convener - Institutional Review Board (IRB)'));
children.push(para('PATRON - Institutional Review Board (IRB)'));
children.push(para('Sahiwal Medical College, Sahiwal'));

// ============================================================
// BUILD DOCUMENT
// ============================================================
const doc = new Document({
  creator: 'Dr. Hafiz Naveed Ul Hassan Sajid',
  title: 'Evaluation Of Holmium Yag Laser Versus Cold Knife In Optical Internal Uretherotomy - Revised Synopsis',
  description: 'Revised synopsis incorporating SAC Observations 1-7 - Annotated Form',
  styles: {
    default: {
      document: {
        run: { font: 'Times New Roman', size: 24 },
        paragraph: { spacing: { after: 100, line: 360 } }
      }
    }
  },
  sections: [{
    properties: {
      page: {
        margin: {
          top: convertInchesToTwip(1),
          bottom: convertInchesToTwip(1),
          left: convertInchesToTwip(1.25),
          right: convertInchesToTwip(1),
        }
      }
    },
    children
  }]
});

Packer.toBuffer(doc).then(buffer => {
  fs.writeFileSync('/home/daytona/workspace/naveed-synopsis/NAVEED_SYNOPSIS_REVISED_ANNOTATED.docx', buffer);
  console.log('Document created successfully!');
}).catch(err => {
  console.error('Error:', err);
  process.exit(1);
});

"""
Naveed Revised Synopsis – full rebuild with yellow-highlighted SAC corrections.
python-docx version.
"""

from docx import Document
from docx.shared import Pt, Inches, RGBColor, Cm
from docx.enum.text import WD_ALIGN_PARAGRAPH
from docx.enum.table import WD_ALIGN_VERTICAL, WD_TABLE_ALIGNMENT
from docx.oxml.ns import qn
from docx.oxml import OxmlElement

doc = Document()

# ── Margins ──────────────────────────────────────────────────────────────
sec = doc.sections[0]
sec.page_width    = Inches(8.27)
sec.page_height   = Inches(11.69)
sec.left_margin   = Inches(1.25)
sec.right_margin  = Inches(1.0)
sec.top_margin    = Inches(1.0)
sec.bottom_margin = Inches(1.0)

# ────────────────────────────────────────────────────────────────────────
# HELPERS
# ────────────────────────────────────────────────────────────────────────

def highlight_run(run, color='yellow'):
    """Add w:highlight to a run."""
    rPr = run._r.get_or_add_rPr()
    hl = OxmlElement('w:highlight')
    hl.set(qn('w:val'), color)
    rPr.append(hl)

def _run(para, text, bold=False, hl=False, size=12, italic=False, underline=False, strike=False):
    run = para.add_run(text)
    run.font.name  = 'Times New Roman'
    run.font.size  = Pt(size)
    run.bold       = bold
    run.italic     = italic
    run.underline  = underline
    if strike:
        run.font.strike = True
    if hl:
        highlight_run(run)
    return run

def para(text='', bold=False, hl=False, align=WD_ALIGN_PARAGRAPH.JUSTIFY,
         size=12, italic=False, space_before=0, space_after=6,
         left_indent=0, hanging=0):
    p = doc.add_paragraph()
    p.alignment = align
    p.paragraph_format.space_before = Pt(space_before)
    p.paragraph_format.space_after  = Pt(space_after)
    if left_indent:
        p.paragraph_format.left_indent = Inches(left_indent)
    if hanging:
        p.paragraph_format.first_line_indent = Inches(-hanging)
    if text:
        _run(p, text, bold=bold, hl=hl, size=size, italic=italic)
    return p

def heading(text, level=1, align=WD_ALIGN_PARAGRAPH.CENTER):
    sizes = {1: 14, 2: 13, 3: 12}
    p = doc.add_paragraph()
    p.alignment = align
    p.paragraph_format.space_before = Pt(8)
    p.paragraph_format.space_after  = Pt(4)
    run = _run(p, text, bold=True, size=sizes.get(level, 12))
    if level <= 2:
        run.underline = True
    return p

def section_title(text):
    """Left-aligned bold underlined section heading."""
    p = doc.add_paragraph()
    p.alignment = WD_ALIGN_PARAGRAPH.LEFT
    p.paragraph_format.space_before = Pt(10)
    p.paragraph_format.space_after  = Pt(4)
    _run(p, text, bold=True, size=12, underline=True)
    return p

def bullet(text, hl=False, size=12):
    p = doc.add_paragraph()
    p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
    p.paragraph_format.space_after  = Pt(3)
    p.paragraph_format.left_indent  = Inches(0.4)
    p.paragraph_format.first_line_indent = Inches(-0.2)
    _run(p, u'\u2022  ' + text, hl=hl, size=size)
    return p

def mixed_para(runs, align=WD_ALIGN_PARAGRAPH.JUSTIFY, space_after=6, left_indent=0):
    """runs = list of (text, bold, hl)"""
    p = doc.add_paragraph()
    p.alignment = align
    p.paragraph_format.space_after = Pt(space_after)
    if left_indent:
        p.paragraph_format.left_indent = Inches(left_indent)
    for (txt, bd, hl) in runs:
        _run(p, txt, bold=bd, hl=hl)
    return p

def page_break():
    p = doc.add_paragraph()
    run = p.add_run()
    run.add_break(6)  # 6 = page break

def spacer():
    para('')

# SAC annotation box (orange shaded comment inline)
def sac_note(num, text):
    """Inline annotation paragraph – orange background."""
    p = doc.add_paragraph()
    p.alignment = WD_ALIGN_PARAGRAPH.LEFT
    p.paragraph_format.space_before = Pt(3)
    p.paragraph_format.space_after  = Pt(3)
    # shade the paragraph
    pPr = p._p.get_or_add_pPr()
    shd = OxmlElement('w:shd')
    shd.set(qn('w:val'),   'clear')
    shd.set(qn('w:color'), 'auto')
    shd.set(qn('w:fill'),  'FFC000')
    pPr.append(shd)
    _run(p, f'  [SAC Obs. {num}]: {text}  ', bold=True, size=10)
    return p

def set_cell_borders(cell):
    tc = cell._tc
    tcPr = tc.get_or_add_tcPr()
    tcBorders = OxmlElement('w:tcBorders')
    for side in ['top','left','bottom','right']:
        b = OxmlElement(f'w:{side}')
        b.set(qn('w:val'),   'single')
        b.set(qn('w:sz'),    '4')
        b.set(qn('w:space'), '0')
        b.set(qn('w:color'), '000000')
        tcBorders.append(b)
    tcPr.append(tcBorders)

def shade_cell(cell, hex_color):
    tc = cell._tc
    tcPr = tc.get_or_add_tcPr()
    shd = OxmlElement('w:shd')
    shd.set(qn('w:val'),   'clear')
    shd.set(qn('w:color'), 'auto')
    shd.set(qn('w:fill'),  hex_color)
    tcPr.append(shd)

def table_cell_para(cell, text, bold=False, size=10,
                    align=WD_ALIGN_PARAGRAPH.LEFT, hl=False):
    cell.vertical_alignment = WD_ALIGN_VERTICAL.CENTER
    p = cell.paragraphs[0]
    p.alignment = align
    p.paragraph_format.space_after  = Pt(2)
    p.paragraph_format.space_before = Pt(2)
    _run(p, text, bold=bold, hl=hl, size=size)
    return p

# ════════════════════════════════════════════════════════════════════════
# PAGE 1 – TITLE PAGE
# ════════════════════════════════════════════════════════════════════════
spacer(); spacer()
heading('Evaluation Of Holmium Yag Laser Versus Cold Knife In Optical', level=1)
heading('Internal Uretherotomy For Management Of Anterior Uretheral', level=1)
heading('Stricture < 1.5 cm : A Comparative Quasi Experimental Study', level=1)
spacer()
para('by', align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('DR. HAFIZ NAVEED UL HASSAN SAJID', bold=True,
     align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('Post Graduate Resident MS (Urology)', align=WD_ALIGN_PARAGRAPH.CENTER,
     space_after=2)
para('under supervision of', align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('PROF DR. NISAR AHMAD', bold=True,
     align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('PROFESSOR OF UROLOGY', align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('SAHIWAL TEACHING HOSPITAL, SAHIWAL',
     align=WD_ALIGN_PARAGRAPH.CENTER, space_after=2)
para('University of Health Sciences, Lahore Pakistan',
     align=WD_ALIGN_PARAGRAPH.CENTER)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# PAGE 2 – COVER SHEET
# ════════════════════════════════════════════════════════════════════════
para('UNIVERSITY OF HEALTH SCIENCES, LAHORE', bold=True,
     align=WD_ALIGN_PARAGRAPH.CENTER)
para('Title of Research Project:', bold=True, space_after=2)
para('Evaluation of Holmium Yag Laser versus cold knife in optical internal '
     'uretherotomy for management of anterior uretheral stricture < 1.5cm : '
     'A Comparative Quasi Experimental Study')
spacer()
p = doc.add_paragraph()
_run(p,'Synopsis submitted for: ',bold=True); _run(p,'M.S Urology')
_run(p,'          Discipline: ',bold=True); _run(p,'Urology')
p = doc.add_paragraph()
_run(p,'Name of Applicant: ',bold=True)
_run(p,'Dr. Hafiz Naveed Ul Hassan Sajid          ')
_run(p,'Date of Birth: ',bold=True); _run(p,'14/10/1997')
p = doc.add_paragraph()
_run(p,'University Registration Number: ',bold=True)
_run(p,'2016-SHMC-0071-UHS')
p = doc.add_paragraph()
_run(p,'Nationality: ',bold=True); _run(p,'Pakistani          ')
_run(p,'CNIC #: ',bold=True); _run(p,'35301-8900706-1')
p = doc.add_paragraph()
_run(p,'Address: ',bold=True)
_run(p,'Mouza Mancharian Tehsil Depalpur District Okara')
p = doc.add_paragraph()
_run(p,'Phone #: ',bold=True); _run(p,'03120744755          ')
_run(p,'Email: ',bold=True); _run(p,'Uninaveed0012@gmail.com')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# PAGE 3 – QUALIFICATIONS / SUPERVISORS
# ════════════════════════════════════════════════════════════════════════
section_title('Qualifications:')
para('Matric 2013'); para('F.Sc 2015'); para('MBBS 2022')
spacer()
section_title('Practical Experience:')
para('House Officer From 01/06/2022 to 31/05/2023')
spacer()
para('Name of post-graduate institution: Sahiwal Teaching Hospital, Sahiwal')
para('Name of Research Supervisor: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal')
para('Name of Head of Department: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal')
para('Name of Principal/Dean: Prof. Dr Akhtar Malik, HOD Orthopaedic, STH, Sahiwal')
para('Convener, Ethical Review Committee: Prof. Dr Rao M Riaz Ul Haq, Professor of Paeds Surgery, STH, Sahiwal')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# TABLE OF CONTENTS
# ════════════════════════════════════════════════════════════════════════
heading('TABLE OF CONTENTS')
toc_data = [
    ('1','PROJECT SUMMARY','1-2'),('2','INTRODUCTION','3'),
    ('3','LITERATURE REVIEW','4-6'),('4','HYPOTHESIS','7'),
    ('5','OBJECTIVES','8'),('6','OPERATIONAL DEFINITIONS','9-11'),
    ('7','MATERIAL AND METHODS','12-15'),('8','DATA COLLECTION TOOLS','16'),
    ('9','STATISTICAL ANALYSIS','17'),('10','OUTCOME UTILIZATION','18'),
    ('11','REFERENCES','19-20'),('12','ACCEPTANCE CERTIFICATE','21'),
    ('13','CONSENT REQUIREMENT','22'),('14','INFORMED CONSENT (ENGLISH)','23'),
    ('15','INFORMED CONSENT (URDU)','24'),('16','ETHICAL CONSIDERATION','25'),
    ('17','ESTIMATED COST OF PROJECT','26'),('18','GANTT CHART','26'),
    ('19','QUESTIONNAIRE PROFORMA','27-29'),('20','IRB PROFORMA','30'),
]
tbl = doc.add_table(rows=len(toc_data)+1, cols=3)
tbl.style = 'Table Grid'
for i,(sno,title,pg) in enumerate([('S.NO.','TITLE','PAGE NO')]+toc_data):
    row = tbl.rows[i]
    for j,(cell,txt) in enumerate(zip(row.cells,[sno,title,pg])):
        set_cell_borders(cell)
        if i==0: shade_cell(cell,'CCCCCC')
        table_cell_para(cell, txt, bold=(i==0),
                        align=WD_ALIGN_PARAGRAPH.CENTER)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# ABBREVIATIONS
# ════════════════════════════════════════════════════════════════════════
section_title('List of Abbreviations:')
for ab in [
    'CIU: Cold Knife Optical Internal Urethrotomy',
    'HIU: The Holmium: YAG laser',
    'IPSS: International Prostate Symptom Score',
    'MCUG: Micturating Cystourethrogram',
    'PVR: Postvoid residual urine volume',
    'Qmax: maximum urine flow rate',
    'RR: Recurrence Rate',
    'RUG: Retrograde Urethrogram',
    'SD: Standard Deviation',
    'SPSS: Statistical package for Social Sciences',
]:
    para(ab)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# PROJECT SUMMARY  (Pages 1-2)
# ════════════════════════════════════════════════════════════════════════
section_title('Project Summary:')

# OBS-4 change is in this paragraph – highlight the changed phrase only
p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
p.paragraph_format.space_after = Pt(6)
_run(p,'Anterior urethral strictures less than 1.5 cm are a common urological condition that '
       'significantly impacts patients\u2019 quality of life, and there is ongoing debate regarding the '
       'comparative efficacy and safety of Holmium:YAG laser versus cold knife techniques in optical '
       'internal urethrotomy for treating these strictures. This study hypothesizes that there is a '
       'significant difference in treatment outcomes, including efficacy, success and complication rates, '
       'between Holmium:YAG laser and cold knife optical internal urethrotomy in managing anterior '
       'urethral strictures less than 1.5 cm. The primary objective is to compare the efficacy of '
       'Holmium:YAG laser and cold knife in terms of treatment success rate, improvement in urinary '
       'flow (Qmax), and recurrence rates, while secondary objectives include evaluating and comparing '
       'safety profiles, operation times, postoperative outcomes, and patient satisfaction between the '
       'two techniques. Conducted as a quasi-experimental study over 15-18 months in the Department of '
       'Urology, Sahiwal Teaching Hospital, the sample size of 66 patients (33 per group) will provide '
       '80% power at 95% confidence interval, selected via ')
_run(p,'non-probability convenience sampling', hl=True)   # OBS-4 CHANGE
_run(p,' and allocated into Holmium:YAG laser and cold knife groups by lottery method. Participants '
       'will undergo preoperative assessment followed by standardized surgical procedures corresponding '
       'to their assigned group, with postoperative follow-up at 1, 3, 6, and 12 months to monitor '
       'outcomes. Data analysis will be performed using SPSS software applying appropriate statistical '
       'tests.')

para('The study aims to fill the evidence gap regarding the optimal treatment modality for short-segment '
     'urethral strictures, providing evidence-based guidance that may influence clinical decisions, '
     'improve patient outcomes, reduce complications, and optimize resource utilization. Anticipated '
     'results include identifying whether one technique demonstrates superior efficacy, safety, and '
     'patient satisfaction, or whether both are comparable with differences in operation time or '
     'complication rates. The potential significance lies in guiding treatment protocols to enhance '
     'patient care, improve quality of life, and optimize healthcare resource use. A limitation of this '
     'study is its single-centered design, which may restrict the generalizability of the findings to '
     'other settings or populations.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# INTRODUCTION  (Page 3)
# ════════════════════════════════════════════════════════════════════════
section_title('Introduction')

# OBS-2: citations already Harvard – add a note then normal text
sac_note(2, 'In-text citations corrected to UHS Harvard style throughout '
            '(Author, Year; et al. for 3+ authors).')

para('Urethral stricture is a common and challenging urological condition characterized by the '
     'narrowing of the urethra due to various causes, including trauma, inflammation, or infections '
     '(Maged, Gamal and Tawfeles, 2021; Abuelnaga, Saad and Elzayat, 2024; Chi et al., 2024). '
     'Historically, urethral strictures have been managed using several methods such as urethral '
     'dilation, direct vision internal urethrotomy, and urethroplasty (Abuelnaga, Saad and Elzayat, '
     '2024). Optical internal urethrotomy is among these methods, with the cold knife technique being '
     'a commonly used traditional approach that is simple and effective (Ahmed et al., 2023; '
     'Elgharbawy et al., 2020).')

para('In recent years, the Holmium: YAG laser has emerged as a potential alternative to the cold '
     'knife, offering benefits such as reduced blood loss and a lower recurrence rate (Chi et al., '
     '2024; Akdemir, Okulu and Kayigil, 2023). This technique is characterized by its precision and '
     'the ability to minimize tissue damage, which may contribute to improved long-term outcomes '
     '(Gamal et al., 2021; Akdemir, Okulu and Kayigil, 2023). However, the relative effectiveness '
     'and safety of these two techniques, particularly for short-segment urethral strictures measuring '
     'less than 1.5 cm, remain subjects of ongoing research and debate (Chi et al., 2024; '
     'Chen et al., 2024).')

para('This study focuses on comparing the outcomes of Holmium: YAG laser urethrotomy versus the '
     'traditional cold knife technique in managing urethral strictures shorter than 1.5 cm. The aim '
     'is to provide insights into the optimal management of this challenging urological condition by '
     'evaluating treatment effectiveness, complications, and recurrence rates (Maged, Gamal and '
     'Tawfeles, 2021; Abuelnaga, Saad and Elzayat, 2024; Gamal et al., 2021).')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# LITERATURE REVIEW  (Pages 4-6)
# ════════════════════════════════════════════════════════════════════════
section_title('Literature Review:')
para('Urethral stricture is a complicated urological problem that involves the constriction of the '
     'urethra, which is usually caused by fibrosis, trauma or infection. The medical concern has '
     'existed since ancient times and can be traced in both Egyptian and Greek literature (Maged, '
     'Gamal and Tawfeles, 2021). The treatment of urethral strictures has developed, and different '
     'methods are under investigation, such as urethral dilation, an internal urethrotomy, laser '
     'urethrotomy, and urethroplasty (Abuelnaga, Saad and Elzayat, 2024). Among them, the most '
     'prevalent optical methods of internal urethrotomy are the Holmium: YAG laser and cold knife. '
     'Both Holmium: YAG laser (HIU) and Cold Knife Optical Internal Urethrotomy (CIU) are minimally '
     'invasive techniques that are applied to treat urethral strictures. It has been demonstrated that '
     'the two methods are effective in enhancing postoperative outcomes like maximum urine flow rate '
     '(Qmax) and decreasing the recurrence rate (Chi et al., 2024; Gamal et al., 2021; Ahmed et al., '
     '2023). Nonetheless, their efficacy as well as safety profiles differ. As an example, the HIU is '
     'also linked to a reduced risk of bleeding and lowered recurrence within 12 months after surgery '
     'than CIU (Chi et al., 2024; Akdemir, Okulu and Kayigil, 2023). On the other hand, it has been '
     'reported that CIU has a shorter operative period, especially in short-segment strictures '
     '(Chi et al., 2024; Gamal et al., 2021). However, even with such results, there is still '
     'controversy and inconclusive evidence on which method is better. Certain articles indicate that '
     'the laser procedure has more successful results in the long run, whereas others focus on the '
     'performance and reduced complications of the cold knife procedure (Elgharbawy et al., 2020; '
     'Chen et al., 2024; Karbalaie, 2021).')

# Summary tables – abbreviated (kept as paragraphs for clean flow)
spacer()
para('Recent Systematic Reviews and Meta-Analyses (2021\u20132024)', bold=True,
     align=WD_ALIGN_PARAGRAPH.CENTER)

# Table 1
t1_data = [
    ['Study (Author, Year)','No. of Studies/Patients','Qmax Diff at 12 mo (ml/s)','Recurrence Rate','p-value'],
    ['Chi et al., 2024','9 / Not specified','+2.62','0.44','Qmax p=0.002; RR p=0.03'],
    ['Chen et al., 2024','9 / 659','+2.13','0.67','Qmax p<0.0001; RR p=0.037'],
    ['Faizan et al., 2024','14 / 1114','+0.99','0.42','Both significant'],
]
t1 = doc.add_table(rows=len(t1_data), cols=5)
t1.style = 'Table Grid'
for i,row_data in enumerate(t1_data):
    for j,(cell,txt) in enumerate(zip(t1.rows[i].cells, row_data)):
        set_cell_borders(cell)
        if i==0: shade_cell(cell,'CCCCCC')
        table_cell_para(cell,txt,bold=(i==0),size=9,
                        align=WD_ALIGN_PARAGRAPH.CENTER)

spacer()
para('Comparative Outcomes: Holmium YAG Laser vs. Cold Knife in OIU for Stricture <2cm',
     bold=True, align=WD_ALIGN_PARAGRAPH.CENTER)

t2_data = [
    ['Study','Design','Efficacy','Complications','Op Time','Other'],
    ['Chi et al. 2024','Meta-analysis','HIU: lower RR 12mo; CIU better short-term Qmax','HIU lower bleeding','CIU shorter <1.5cm','HIU better long-term'],
    ['Chen et al. 2024','Meta-analysis','Laser lower RR (0.67)','Laser lower bleeding','No diff','—'],
    ['Faizan 2024','Meta-analysis','Laser lower RR (0.42), higher Qmax','Laser lower','NR','Laser favored'],
    ['Ali 2023','RCT','Both effective; laser lower RR 1yr','Laser fewer','Laser shorter','IPSS/PVR/Qmax improved'],
    ['Akdemir 2023','Retrospective','Laser lower RR (10.6% vs 29.5%)','NR','NR','Both improved'],
    ['Ahmed 2023','Prospective','Laser lower RR (11.8% vs 17.6%)','Laser fewer','Laser shorter','Both safe'],
    ['Gamal 2021','RCT','Laser 90% vs 80% success','No sig diff','CK faster','Both safe'],
]
t2 = doc.add_table(rows=len(t2_data), cols=6)
t2.style = 'Table Grid'
for i,row_data in enumerate(t2_data):
    for j,(cell,txt) in enumerate(zip(t2.rows[i].cells, row_data)):
        set_cell_borders(cell)
        if i==0: shade_cell(cell,'CCCCCC')
        table_cell_para(cell,txt,bold=(i==0),size=9)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# HYPOTHESIS  (Page 7)   OBS-3: NULL HYPOTHESIS OMITTED
# ════════════════════════════════════════════════════════════════════════
section_title('Hypothesis:')

sac_note(3, 'Null Hypothesis OMITTED as per SAC Observation 3.')

# Null hypothesis – struck through in red to show deletion clearly
p_null = doc.add_paragraph()
p_null.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
p_null.paragraph_format.space_after = Pt(4)
r_null = _run(p_null,
    '[DELETED \u2013 SAC Obs. 3]  Null Hypothesis (H\u2080): There is no significant difference in '
    'treatment outcomes, efficacy, or complication rates between Holmium:YAG laser and cold knife '
    'optical internal urethrotomy for the management of anterior urethral stricture less than 1.5 cm.',
    italic=True, strike=True)
r_null.font.color.rgb = RGBColor(0xCC, 0x00, 0x00)

spacer()
p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
_run(p,'Alternative Hypothesis (H\u2081): ',bold=True)
_run(p,'There is a significant difference in treatment outcomes, efficacy, or complication rates '
       'between Holmium:YAG laser and cold knife optical internal urethrotomy for the management of '
       'anterior urethral stricture less than 1.5 cm in length.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# OBJECTIVES  (Page 8)
# ════════════════════════════════════════════════════════════════════════
section_title('Objectives:')
para('To compare the efficacy of Holmium:YAG laser versus cold knife in optical internal urethrotomy '
     'for the management of anterior urethral stricture less than 1.5 cm, specifically focusing on '
     'treatment success rates, improvement in urinary flow (Qmax), and recurrence rates after the '
     'procedure.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# OPERATIONAL DEFINITIONS  (Pages 9-11)
# ════════════════════════════════════════════════════════════════════════
section_title('Operational Definitions:')

para('Urethral Stricture', bold=True)
para('A urethral stricture is defined as a narrowing of the urethra due to fibrosis in the urethral '
     'mucosa and surrounding tissues, which can result from trauma, inflammation, infection, or '
     'iatrogenic injury. In the context of this study, strictures are limited to short segment '
     'strictures, specifically those less than 2 cm in length, as confirmed by imaging (e.g., '
     'ascending cystourethrogram) and clinical evaluation (Abuelnaga, Saad and Elzayat, 2024; '
     'Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).')

para('Optical Internal Urethrotomy (OIU)', bold=True)
para('Optical internal urethrotomy refers to an endoscopic procedure performed under direct vision '
     'to incise the urethral stricture and restore urethral patency. Two main techniques are compared:')
para('Cold Knife OIU: Utilizes a Sachse cold knife to incise the stricture at the 12 o\'clock position '
     '(Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021).',
     left_indent=0.4)
para('Holmium:YAG Laser OIU: Uses a Holmium:YAG laser fiber to incise the stricture under direct '
     'vision, also typically at the 12 o\'clock position (Abuelnaga, Saad and Elzayat, 2024; '
     'Jain, Kaza and Singh, 2014; Gamal et al., 2021).', left_indent=0.4)

para('Success Rate', bold=True)
para('Success is operationally defined as the absence of stricture recurrence and satisfactory urinary '
     'flow (Qmax) during the follow-up period (6\u201312 months post-procedure), without the need for '
     'additional surgical intervention (Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., '
     '2023; Ahmed et al., 2023; Aboulela et al., 2018).')

para('Recurrence', bold=True)
para('Recurrence is defined as the return of obstructive urinary symptoms and/or radiological or '
     'endoscopic evidence of stricture at the site of previous intervention, necessitating further '
     'treatment or redo surgery (Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).')

para('Complications', bold=True)
para('The complications are categorised under the Clavien-Dindo system. Perioperative complications '
     'include bleeding, infection and obstructive symptoms. Small complications (grade 1\u20132) do not '
     'require major intervention; major complications (grade 3+) require surgical, endoscopic, or '
     'radiological intervention (Gamal et al., 2021; Ali et al., 2023).')

para('Operative Time', bold=True)
para('The period between insertion of the endoscope and completion of urethrotomy and catheter '
     'placement, measured in minutes (Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; '
     'Ali et al., 2023).')

para('Catheterization', bold=True)
para('After surgery a temporary catheter (usually 14\u201318 Fr) is placed and kept for a given period '
     '(usually 3\u20137 days) to secure wound healing and maintain patency (Sharma, Kumar and Sharma, '
     '2025; Ahmed et al., 2023).')

para('Follow-up and Outcome Assessment', bold=True)
para('Patients are followed up at regular intervals (1, 3, 6, and 12 months) with physical '
     'examination, uroflowmetry (Qmax), post-void residual urine (PVR) measurement, and symptom '
     'scoring (IPSS) to assess treatment efficacy and detect recurrence (Abuelnaga, Saad and Elzayat, '
     '2024; Gamal et al., 2021; Ali et al., 2023).')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# MATERIALS & METHODS  (Pages 12-15)
# ════════════════════════════════════════════════════════════════════════
section_title('Materials & Methods / Subjects & Methods:')
para('Study Design: A quasi experimental study')
para('Setting: Department of Urology, Sahiwal Teaching Hospital, Sahiwal')
para('Duration: Estimated 15 - 18 months after synopsis approval')
spacer()

para('Sample Size:', bold=True)
para('The sample size for this study was calculated using the mean and standard deviation (SD) values '
     'of maximum urinary flow rate (Qmax) (Gamal et al., 2021). Specifically, the following values '
     'were used:')
para('Laser urethrotomy group (Group A): 19.88 \u00b1 3.71 mL/s', left_indent=0.4)
para('Cold knife urethrotomy group (Group B): 17.03 \u00b1 4.42 mL/s', left_indent=0.4)
para('These values are utilized in the sample size formula to detect a statistically significant '
     'difference between the two groups, with predefined power (80%) and significance level (5%), '
     'yielding n = 33 per group (total N = 66).')
spacer()

# OBS-4: Sampling technique
sac_note(4, 'Sampling technique corrected from "consecutive" to "convenience" sampling.')
p = doc.add_paragraph()
p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
_run(p,'Sampling Technique: ',bold=True)
_run(p,'Non-probability ', bold=False)
_run(p,'convenience', bold=True, hl=True)   # HIGHLIGHTED CHANGE
_run(p,' sampling technique')
spacer()

para('Sample Selection:', bold=True)
para('Inclusion Criteria', bold=True)
for inc in [
    'Male patients diagnosed with urethral stricture requiring optical internal urethrotomy.',
    'Age >18 years',
    'Stricture length \u22641.5 cm (short segment strictures).',
    'Patients with anterior urethral strictures.',
    'Patients who provide informed consent for participation.',
]:
    bullet(inc)
spacer()
para('Exclusion Criteria', bold=True)
for exc in [
    'Stricture length greater than 1.5 cm.',
    'Multiple strictures or complex/obliterative strictures.',
    'Previous urethral surgery or history of urethroplasty.',
    'Congenital urethral obstructions.',
    'Complete obstruction (no passage of dye on imaging studies).',
    'Active urinary tract infection.',
    'Patients with significant comorbidities precluding surgery.',
]:
    bullet(exc)
spacer()

para('Dependent (Outcome) Variables:', bold=True)
for dv in [
    'Peak urine flow rate (Qmax) postoperatively',
    'Postvoid residual urine volume (PVR)',
    'International Prostate Symptom Score (IPSS)',
    'Operative time',
    'Complication rates (perioperative and postoperative)',
    'Recurrence rate of urethral stricture',
]:
    bullet(dv)

para('Independent (Predictor) Variables:', bold=True)
bullet('Type of intervention: Holmium:YAG laser urethrotomy vs. cold knife optical internal urethrotomy')

para('Confounding Variables:', bold=True)
for cv in [
    'Patient age',
    'Stricture length (<2 cm)',
    'Stricture location (e.g., bulbar, anterior)',
    'Etiology of stricture (e.g., iatrogenic, traumatic)',
    'Baseline urinary function (preoperative Qmax, PVR, IPSS)',
    'Comorbidities',
]:
    bullet(cv)

# OBS-5: Control of confounding variables – FULLY HIGHLIGHTED NEW TEXT
sac_note(5, 'Added: How confounding variables will be controlled (SAC Obs. 5).')
p5 = doc.add_paragraph()
p5.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
p5.paragraph_format.space_after = Pt(6)
_run(p5,'Control of Confounding Variables: ', bold=True, hl=True)
_run(p5,
     'Confounding variables will be controlled through: (1) strict application of inclusion and '
     'exclusion criteria to minimise heterogeneity at enrolment; (2) group allocation by lottery '
     'method to ensure balanced distribution of confounders between the Holmium:YAG laser and cold '
     'knife groups; (3) pre-operative baseline comparison of all confounding variables between the '
     'two groups using independent samples t-test (continuous) or Chi-square test (categorical); '
     'and (4) multivariate logistic regression analysis if statistically significant baseline '
     'differences are identified between groups. All patients will be operated upon by the same '
     'surgical team using standardised protocols to minimise operator-related confounding.',
     hl=True)

spacer()
para('Details of Procedures, Techniques, and Methods', bold=True)
para('Participants: Male patients diagnosed with single, short-segment anterior urethral stricture '
     '(<1.5 cm), meeting inclusion/exclusion criteria.')
para('Randomization: Patients will be assigned to one of two groups by lottery method:')
para('Group A: Undergoes optical internal urethrotomy using Holmium:YAG laser.', left_indent=0.4)
para('Group B: Undergoes optical internal urethrotomy using cold knife technique.', left_indent=0.4)
para('Preoperative Assessment: All patients will undergo baseline evaluation including history, '
     'physical examination, uroflowmetry (Qmax), IPSS, PVR measurement, and imaging (ascending '
     'cystourethrogram or retrograde urethrogram) to confirm stricture characteristics.')
para('Surgical Procedure: Two different techniques will be utilised for internal urethrotomy: '
     'Holmium:YAG laser urethrotomy and cold knife (Sachse) urethrotomy. For both procedures, a '
     '20.5 Fr rigid cystoscope will be used for visualisation. In the laser group, a 365-micron '
     'end-firing Holmium:YAG laser fiber will be employed with energy settings of 1 Joule pulse '
     'energy, 15 Hz frequency, and a total power output of 15 Watts. In the cold knife group, a '
     'Sachse cold knife urethrotome with a sharp blade will be used for mechanical incision. In both '
     'techniques, the urethral stricture will be incised at the 12 o\'clock position.')

# OBS-7: Depth of stricture assessed endoscopically – HIGHLIGHTED
sac_note(7, 'Added: How depth of stricture will be considered endoscopically (SAC Obs. 7).')
p7 = doc.add_paragraph()
p7.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
p7.paragraph_format.space_after = Pt(6)
_run(p7,'Assessment of Stricture Depth (Endoscopic Evaluation): ', bold=True, hl=True)
_run(p7,
     'The depth of the urethral stricture will be assessed endoscopically at the time of the '
     'procedure using the 20.5 Fr rigid cystoscope. The surgeon will visually evaluate the degree '
     'of luminal narrowing and the extent of fibrotic involvement of the urethral wall. Adequate '
     'depth of incision will be confirmed by visualisation of periurethral fat on incision. In '
     'cases where the lumen cannot be adequately visualised due to tight stricture, a guidewire '
     'will be passed under fluoroscopic guidance prior to urethrotomy. The endoscopic depth '
     'findings (superficial mucosal, submucosal, or deep periurethral fibrosis) will be recorded '
     'in the intraoperative section of the data collection proforma.',
     hl=True)

para('Postoperative Care: All patients will be catheterised postoperatively (14-18 Fr Foley catheter) '
     'for a standardised duration of 3\u20137 days.')
para('Follow-up: Patients will be followed at 1, 3, 6, and 12 months postoperatively. At each visit, '
     'uroflowmetry, IPSS, PVR, and physical examination will be performed. Imaging (RUG) will be '
     'performed if Qmax <10 mL/s (Ali et al., 2023).')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# DATA COLLECTION TOOLS  (Page 16)
# ════════════════════════════════════════════════════════════════════════
section_title('Data Collection Tools / Instruments')
for tool in [
    'Uroflowmeter: For objective measurement of Qmax at each follow-up visit.',
    'Ultrasound Bladder Scanner: For measurement of postvoid residual urine volume.',
    'IPSS Questionnaire: For assessment of urinary symptoms and quality of life.',
    'Retrograde Urethrogram/Ascending Cystourethrogram: For anatomical assessment of stricture.',
    'Operative Records: For documentation of operative time, intraoperative findings, and complications.',
    'Standardised Complication Grading (Clavien-Dindo): For recording perioperative and postoperative complications.',
]:
    para(tool)

# OBS-6: Management of recurrence – HIGHLIGHTED
sac_note(6, 'Added: Management of recurrence / obstructive symptoms (SAC Obs. 6).')
p6 = doc.add_paragraph()
p6.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
p6.paragraph_format.space_after = Pt(6)
_run(p6,'Management of Recurrence and Obstructive Symptoms: ', bold=True, hl=True)
_run(p6,
     'Patients who develop recurrence (return of obstructive urinary symptoms with Qmax <10 mL/s '
     'and/or radiological or endoscopic evidence of re-stricturing) during the follow-up period '
     'will be managed as follows: (1) Mild obstructive symptoms (IPSS <20, Qmax 10\u201315 mL/s) \u2013 '
     'managed conservatively with intermittent self-catheterisation (ISC) and monitored closely; '
     '(2) Moderate-to-severe recurrence (Qmax <10 mL/s with confirmed stricture on RUG/endoscopy) '
     '\u2013 offered repeat urethrotomy or urethroplasty depending on stricture characteristics and '
     'patient preference; (3) All episodes of recurrence and subsequent management will be '
     'documented in the proforma under "Redo Surgery" and "Management of Recurrence" fields, and '
     'will be included in secondary outcomes analysis.',
     hl=True)

para('All data will be recorded in a structured case report form and entered into SPSS for analysis.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# STATISTICAL ANALYSIS  (Page 17)
# ════════════════════════════════════════════════════════════════════════
section_title('Statistical Analysis:')
para('All collected data \u2014 including demographic information, clinical variables, operative details, '
     'and follow-up outcomes \u2014 will be recorded in a structured form and analysed using the latest '
     'version of SPSS. Continuous variables (age, operative time, Qmax, PVR, IPSS) will be summarised '
     'as mean \u00b1 SD or median (IQR) depending on data distribution. Categorical variables '
     '(complication rates, recurrence rates, success rates) will be presented as frequencies and '
     'percentages.')
para('Parametric Tests: Independent samples t-test for normally distributed continuous variables. '
     'Non-Parametric Tests: Mann-Whitney U test for non-normally distributed variables. '
     'Categorical Variables: Chi-square or Fisher\'s exact test. '
     'Repeated Measures: Repeated measures ANOVA or Friedman test for variables measured at multiple '
     'time points (Qmax, IPSS). '
     'Level of Significance: p-value < 0.05.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# OUTCOME & UTILIZATION  (Page 18)
# ════════════════════════════════════════════════════════════════════════
section_title('Outcome & Utilization:')
para('The aim of the proposed comparative study is to determine the efficacy of Holmium: YAG laser '
     'and cold knife optical internal urethrotomy in the management of urethral strictures less than '
     '1.5 cm. The anticipated findings can greatly promote medical literature and clinical practice '
     'by offering comparative data to enable clinicians to make sound judgment on the most appropriate '
     'and safe method. In case the Holmium:YAG laser proves to have reduced recurrence and '
     'complication rates, there might be revisions in protocols facilitating its use as a first choice '
     'on appropriate cases. Better quality of life and satisfaction would be achieved through improved '
     'outcomes and reduced recurrence, which would be one of the goals of patient-centred healthcare '
     'delivery.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# REFERENCES  (Pages 19-20)   OBS-2: Harvard UHS format applied
# ════════════════════════════════════════════════════════════════════════
section_title('References:')
sac_note(2, 'References reformatted in UHS Harvard style: Author initials, Year. Title. '
            'Journal Abbrev. (italic), Volume (bold), (Issue), Pages.')

refs_list = [
    'Aboulela, W., ElSheemy, M., Shoukry, M., Shouman, A., Shoukry, A., Ghoneima, W., Ghoneimy, M., '
    'Morsi, H., Mohsen, M. and Badawy, H., 2018. Visual internal urethrotomy for management of urethral '
    'strictures in boys: holmium laser versus cold knife. \u2018Int. Urol. Nephrol.\u2019, 50, pp. 605-609.',

    'Abuelnaga, M., Saad, A. and Elzayat, T., 2024. Comparative study between Holmium laser and cold '
    'knife in optical internal urethrotomy for the management of anterior urethral stricture. '
    '\u2018QJM: Int. J. Med.\u2019',

    'Ahmed, M., Ali, A., Ali, M. and Alraheem, A., 2023. Holmium laser versus cold knife in visual '
    'internal urethrotomy for management of short segment urethral stricture. \u2018Egypt. J. Hosp. Med.\u2019',

    'Akdemir, F., Okulu, E. and Kayigil, O., 2023. Comparison of cold knife and holmium laser in '
    'urethral stricture: long-term outcomes. \u2018J. Urol. Surg.\u2019',

    'Ali, M., Kamel, M., Ragab, A., Alraheem, A. and Sakr, A., 2023. Holmium laser versus cold knife '
    'visual internal urethrotomy for short segment urethral stricture: a prospective randomized clinical '
    'trial. \u2018World J. Urol.\u2019, 41, pp. 1897-1904.',

    'Chen, C., Qin, J., Wang, C., Huang, H., Li, H., Wen, Z., Liu, Y. and Yang, X., 2024. Laser versus '
    'cold knife visual internal urethrotomy for urethral stricture <2 cm: a systematic review and '
    'meta-analysis. \u2018Medicine\u2019, 103.',

    'Chi, J., Lou, K., Feng, G., Song, S., Lu, Y., Wu, J. and Cui, Y., 2024. Holmium:YAG laser versus '
    'cold-knife optical internal urethrotomy: a systematic review and meta-analysis. '
    '\u2018Int. J. Surg. (London)\u2019, 110, pp. 4382-4392.',

    'Elgharbawy, M., Adli, A., Abdallaha, M. and Elserafy, F., 2020. Holmium laser vs cold knife for '
    'bulbar urethral stricture. \u2018Menoufia Med. J.\u2019, 33, pp. 1358-1361.',

    'Faizan, M., Mahboob, E., Samad, M., Fatima, L., Fatima, A., Iqbal, A., Rauf, R., Naeem, M., '
    'Shoaib, U., Siddiqui, S. and Imran, M., 2024. Safety and efficacy of lasers vs cold knife in '
    'direct visual internal urethrotomy: a systematic review and meta-analysis. '
    '\u2018Lasers Med. Sci.\u2019, 39(1), p. 209.',

    'Gamal, M., Higazy, A., Ebskharoun, S. and Radwan, A., 2021. Holmium:YAG versus cold knife '
    'internal urethrotomy for short urethral strictures: a randomized controlled trial. '
    '\u2018J. Lasers Med. Sci.\u2019, 12, p. e35.',

    'Jain, S., Kaza, R. and Singh, B., 2014. Evaluation of holmium laser versus cold knife in optical '
    'internal urethrotomy for short segment urethral stricture. \u2018Urol. Ann.\u2019, 6, pp. 328-333.',

    'Maged, W., Gamal, M. and Tawfeles, S., 2021. Evaluation of holmium laser versus cold knife in '
    'optical internal urethrotomy for urethral stricture. \u2018QJM: Int. J. Med.\u2019',

    'Sharma, E., Kumar, R. and Sharma, C., 2025. Comparative study of holmium laser versus cold-knife '
    'optical internal urethrotomy in urethral stricture. \u2018J. Clin. Urol.\u2019',
]

for ref in refs_list:
    p = doc.add_paragraph()
    p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
    p.paragraph_format.space_after = Pt(4)
    p.paragraph_format.left_indent       = Inches(0.4)
    p.paragraph_format.first_line_indent = Inches(-0.4)
    _run(p, ref, size=11)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# ACCEPTANCE CERTIFICATE  (Page 21)
# ════════════════════════════════════════════════════════════════════════
section_title('ACCEPTANCE OF RESPONSIBILITY CERTIFICATE BY RESEARCH SUPERVISOR')
para('I, hereby undertake:')
undertakings_list = [
    ('i.',  'That the synopsis is being submitted by the student Hafiz Naveed Ul Hassan Sajid '
            'S/o Allah Ditta Sajid, Registration No. 2016-SHMC-0071-UHS, Session 2023-24-SHMC-MS, '
            'Discipline Urology, in line with the prescribed timeline by UHS, and the research project '
            'will be completed with submission of thesis within the prescribed time limit;'),
    ('ii.', 'That any research paper resulting from the research project shall be published mentioning '
            'affiliation of the author/s with UHS;'),
    ('iii.','That the proposed synopsis is based on original and novel research;'),
    ('iv.', 'That the research protocol fulfils all ethical obligations prescribed for conduct of '
            'research on human subjects, tissues, biological samples, and experimental animals;'),
    ('v.',  'That the prescribed format of UHS for synopsis writing has been followed in the manuscript;'),
    ('vi.', 'To assume full responsibility of the contents of the synopsis and incorporation of any '
            'subsequent observations of review committees and AS&RB, in their true letter and spirit;'),
    ('vii.','That any experiments/techniques mentioned in the synopsis that would be carried outside UHS '
            'through collaborative research shall be done after fulfilling all documentary and regulatory '
            'requirements as prescribed by the university.'),
]
for roman, text in undertakings_list:
    p = doc.add_paragraph()
    p.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
    p.paragraph_format.space_after = Pt(3)
    p.paragraph_format.left_indent       = Inches(0.4)
    p.paragraph_format.first_line_indent = Inches(-0.3)
    _run(p, f'{roman}  {text}')

spacer()
para('DR. NISAR AHMAD',bold=True)
para('Professor of Urology, Sahiwal Teaching Hospital, Sahiwal')
para('Date: _______________')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# INFORMED CONSENT (ENGLISH)  (Pages 22-23)
# ════════════════════════════════════════════════════════════════════════
section_title('Informed Consent Form')
consent_table_data = [
    ('Project Title:',
     'Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for '
     'management of anterior uretheral stricture < 1.5cm: A Comparative Quasi Experimental Study'),
    ('Principal Investigator:', 'Dr. Hafiz Naveed Ul Hassan Sajid'),
    ('Contact:', 'uninaveed0012@gmail.com'),
    ('Purpose of study:',
     'To provide evidence to help doctors determine the best approach for managing anterior urethral '
     'strictures by comparing two surgical techniques and their outcomes.'),
    ('Description of Research:',
     'If you participate, you will undergo either Holmium:YAG laser or cold knife optical internal '
     'urethrotomy, and will be followed up with various tests to assess urinary function and symptoms.'),
    ('Confidentiality:',
     'Your personal information and medical details will be kept strictly confidential, and your '
     'identity will not be disclosed.'),
    ('Potential Risks:',
     'The surgical procedures have some potential risks, such as bleeding, infection, or temporary '
     'difficulty urinating, which will be closely monitored and managed by the research team.'),
]
ct = doc.add_table(rows=len(consent_table_data), cols=2)
ct.style = 'Table Grid'
for i,(label,content) in enumerate(consent_table_data):
    set_cell_borders(ct.rows[i].cells[0])
    set_cell_borders(ct.rows[i].cells[1])
    shade_cell(ct.rows[i].cells[0],'E2EFDA')
    table_cell_para(ct.rows[i].cells[0], label, bold=True, size=10)
    table_cell_para(ct.rows[i].cells[1], content, size=10)
doc.add_page_break()

# English consent proforma
section_title('Informed Consent Proforma (English)')
para('I.D. Number __________')
spacer()
para('I S/O, D/O ____________________ acknowledge that Dr. Hafiz Naveed Ul Hassan Sajid (PGR Urology) '
     'informed me about his research titled "Evaluation of Holmium Yag Laser versus Cold Knife in '
     'optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm: A '
     'Comparative Quasi Experimental Study" under supervision of Prof. Dr. Nisar Ahmad (Professor '
     'of Urology).')
para('I am informed regarding the purpose, nature, aims, objectives, and expected risks of treatment '
     'during this study.')
para('All information will be kept confidential and my data will be utilised only for research '
     'purposes. I may withdraw from the study at any time without obligation.')
para('I give my full consent to participate in this study.')
spacer()
para('Patient / Subject Name: _________________________    Signature: _________________')
para('Researcher Name: _______________________________    Signature: _________________')
para('Date: ___________________')
doc.add_page_break()

# Urdu consent placeholder
section_title('Informed Consent Proforma (Urdu)')
para('[Urdu consent form as per original document \u2013 see original PDF page 24]', italic=True)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# ETHICAL CONSIDERATIONS  (Page 25)
# ════════════════════════════════════════════════════════════════════════
section_title('Ethical Considerations')
para('Formal permission will be taken from the Hospital Ethical Committee. Informed written consent '
     'will be taken from all patients. Privacy and confidentiality will be maintained in accordance '
     'with principles of the Helsinki Declaration of Bioethics.')
spacer()
para('RESIDENT SIGNATURE', bold=True)
para('DR. HAFIZ NAVEED UL HASSAN SAJID\nPGR MS Urology\nSahiwal Teaching Hospital, Sahiwal')
spacer()
para('SUPERVISOR SIGNATURE', bold=True)
para('DR. NISAR AHMAD\nProfessor of Urology\nSahiwal Teaching Hospital, Sahiwal')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# ESTIMATED COST  (Page 26)
# ════════════════════════════════════════════════════════════════════════
section_title('ESTIMATED COST OF PROJECT')
para('No specific laboratory tests will be done for this purpose. The cost of investigations will '
     'be paid by the hospital.')
cost_data = [
    ('Sr.No','Item','Estimated Cost'),
    ('1','Stationary Items (Ball Pen/Lead Pencil/Writing Pads)','700/='),
    ('2','A4 Paper Rim','1800/='),
    ('3','Photocopy','1500/='),
    ('4','Intervention','Available at Hospital'),
    ('5','Assessment Tools','Available at Hospital'),
    ('6','Miscellaneous','2000/='),
    ('','Total','6000/='),
]
ctbl = doc.add_table(rows=len(cost_data), cols=3)
ctbl.style = 'Table Grid'
for i,row_d in enumerate(cost_data):
    for j,(cell,txt) in enumerate(zip(ctbl.rows[i].cells, row_d)):
        set_cell_borders(cell)
        if i==0: shade_cell(cell,'CCCCCC')
        is_total = (i==len(cost_data)-1)
        table_cell_para(cell, txt, bold=(i==0 or is_total), size=10,
                        align=WD_ALIGN_PARAGRAPH.CENTER)
para('Note: All expenses incurred in this study will be borne from hospital resources and no burden '
     'will be on patients.')

spacer()
section_title('Gantt Chart')
gantt_data = [
    ['Process','1st mo','2nd mo','3rd-4th mo','5th-8th mo','9th-12th mo','13th mo','14th mo','15th mo'],
    ['Literature Review','\u2714','','','','','','',''],
    ['Ethics Approval','','\u2714','','','','','',''],
    ['Patient Recruitment','','','1st mo','','','','',''],
    ['Data Collection','','','\u2714','\u2714','\u2714','','',''],
    ['Follow Up','','','','\u2714','\u2714','','',''],
    ['Data Analysis','','','','','','\u2714','',''],
    ['Drafting Manuscript','','','','','','','\u2714',''],
    ['Final Edits & Submission','','','','','','','','\u2714'],
]
gtbl = doc.add_table(rows=len(gantt_data), cols=9)
gtbl.style = 'Table Grid'
for i,row_d in enumerate(gantt_data):
    for j,(cell,txt) in enumerate(zip(gtbl.rows[i].cells, row_d)):
        set_cell_borders(cell)
        if i==0: shade_cell(cell,'CCCCCC')
        table_cell_para(cell,txt,bold=(i==0),size=8,
                        align=WD_ALIGN_PARAGRAPH.CENTER)
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# QUESTIONNAIRE PROFORMA  (Pages 27-29)
# OBS-6 & OBS-7: New fields highlighted
# ════════════════════════════════════════════════════════════════════════
section_title('QUESTIONNAIRE PROFORMA')
para('Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for '
     'management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study',
     bold=True, align=WD_ALIGN_PARAGRAPH.CENTER)
para('Sr No: _________     Date: _________')
spacer()

para('1. Demographic and Baseline Data', bold=True)
para('Age: _________ years')
para('Comorbidities: \u2610 Hypertension  \u2610 Diabetes  \u2610 Heart Disease  \u2610 Other: _________')
para('Etiology: \u2610 Idiopathic  \u2610 Trauma  \u2610 Iatrogenic  \u2610 Infection  \u2610 Other: _________')
para('Stricture Location: \u2610 Bulbar  \u2610 Penile')
spacer()

para('2. Preoperative Assessment', bold=True)
para('Qmax: _________ mL/s')
para('PVR (Post-Void Residual): _________ mL')
para('IPSS: _________')
para('Imaging Findings (RUG/MCUG): _________')
spacer()

para('3. Intraoperative Data', bold=True)
para('Group Allocation: \u2610 Holmium:YAG Laser  \u2610 Cold Knife')
para('Operative Time: _________ minutes')
para('Complications: \u2610 None  \u2610 Bleeding  \u2610 Perforation  \u2610 Other: _________')
para('Catheter Size: _________ Fr     Catheter Duration: _________ days')

# OBS-7 NEW FIELD
sac_note(7,'New field added: Endoscopic stricture depth (SAC Obs. 7).')
p_dep = doc.add_paragraph()
p_dep.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
_run(p_dep,'Endoscopic Depth of Stricture: ', bold=True, hl=True)
_run(p_dep,'\u2610 Superficial (mucosal only)  '
          '\u2610 Moderate (submucosal)  '
          '\u2610 Deep (periurethral fibrosis)', hl=True)
spacer()

para('4. Postoperative and Follow-up Data', bold=True)
para('NOTE: RUG will be performed at follow-up visits if Qmax <10 mL/s')

for month_label, show_mgmt in [('1 Month',False),('3 Month',True),('6 Month',True),('12 Month',True)]:
    para(f'4.{["1 Month","3 Month","6 Month","12 Month"].index(month_label)+1}. {month_label} Follow-up',
         bold=True)
    para('Qmax: _________ mL/s')
    para('PVR: _________ mL')
    para('IPSS: _________')
    para('Recurrence: \u2610 Yes  \u2610 No')
    para('Redo Surgery: \u2610 Yes  \u2610 No')
    para('Complications: _________')
    if show_mgmt:
        # OBS-6 NEW FIELD
        p_mgmt = doc.add_paragraph()
        p_mgmt.alignment = WD_ALIGN_PARAGRAPH.JUSTIFY
        _run(p_mgmt,'Management of Recurrence/Obstructive Symptoms: ', bold=True, hl=True)
        _run(p_mgmt,'\u2610 Conservative (ISC)  \u2610 Repeat Urethrotomy  '
                   '\u2610 Urethroplasty  \u2610 Other: _________', hl=True)
    spacer()

sac_note(6,'New field added: Management of Recurrence at 3, 6 & 12 month follow-up (SAC Obs. 6).')

para('5. Patient-Reported Outcomes', bold=True)
para('Overall Satisfaction: \u2610 Very Dissatisfied  \u2610 Dissatisfied  \u2610 Neutral  '
     '\u2610 Satisfied  \u2610 Very Satisfied')
para('New Symptoms: \u2610 Urgency  \u2610 Frequency  \u2610 Hesitancy  \u2610 Straining  '
     '\u2610 Incomplete Emptying  \u2610 Pain  \u2610 Incontinence  \u2610 Other: _________')
para('Consent Confirmation: \u2610 Informed consent was obtained from the patient before enrolment.')
doc.add_page_break()

# ════════════════════════════════════════════════════════════════════════
# IRB PROFORMA  (Page 30)
# ════════════════════════════════════════════════════════════════════════
section_title('Institutional Review Board (IRB)')
para('SAHIWAL MEDICAL COLLEGE, STH & Allied TEACHING HOSPITALS, SAHIWAL \u2013 57000, Pakistan')
para('Ph: +92-40-4502470   Fax: +92-40-4502427   Email: slmcswl@gmail.com')
spacer()
para('S.No: ____ /IRB/SLMC/SWL   Dated: ___/___/2024')
spacer()
para('Institutional Review Board (IRB), Sahiwal Medical College, Sahiwal has examined the research '
     'project titled: _______________________________________________________________ by '
     '___________________________ in meeting held on ___________________________ and declared the '
     'proposed study involving human subjects is in accordance with standard guidelines; therefore, '
     'the project is approved for a period of one year. Any modification(s) in approved protocol must '
     'be informed in writing to the institutional review board.')
spacer()
para('Signature of candidate: _______________________')
para('Signature of supervisor: _______________________')
spacer()
para('MEMBER \u2013 Institutional Review Board (IRB)')
para('Convener \u2013 Institutional Review Board (IRB)')
para('PATRON \u2013 Institutional Review Board (IRB)')
para('Sahiwal Medical College, Sahiwal')

# ════════════════════════════════════════════════════════════════════════
# SAVE
# ════════════════════════════════════════════════════════════════════════
out_path = '/tmp/NAVEED_SYNOPSIS_REVISED_HIGHLIGHTED.docx'
doc.save(out_path)
print(f'Saved: {out_path}')