Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias
Phase: NA
Conditions: Ventral Hernia Repair, Abdominal Hernia
Sponsor: GSVM Medical College

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
Title: Comparative Study Between eTEP-RS and IPOM Plus for Abdominal Wall Hernias 
Principal Investigator: Dr. Kavita Sijwali 
Institution: GSVM MEDICAL COLLEGE, KANPUR 
Version: 1.0 
Date: June 2025 
NCT Number: [To be assigned after registration] 
 
1. Background and Rationale 
Abdominal wall hernias are common surgical conditions. Minimally invasive approaches like 
eTEP-RS (enhanced view totally extraperitoneal–retromuscular repair) and IPOM Plus 
(intraperitoneal onlay mesh with defect closure) are widely used. However, comparative data 
on clinical outcomes, complication rates, and recovery between these techniques are limited. 
2. Objectives 
Primary Objective: 
To compare eTEP-RS and IPOM-PLUS in terms of: 
 Operative time 
 Recurrence rate 
 Quality of life 
 Post operative pain and chronic pain 
 Surgical site infection 
 Hospital stay 
 Seroma and hematoma formation 
 
Secondary Objectives: 
 
Calculation of conversion rate of eTEP-RS or IPOM PLUS to open hernia surgery. 
 
Intraoperative complications. 
3. Study Design 
 
Type: Prospective, Randomized, Interventional Trial 
 
Model: Parallel Assignment 
 
Masking: None (Open Label) 
 
Allocation: Randomized 
 
Primary Purpose: Treatment 
4. Eligibility Criteria 

Inclusion Criteria: 
 
Adults aged 18–60 years 
 
Patient with uncomplicated ventral hernia with defect size 2- 5 cm 
 
Elective surgical cases(non- emergency) 
Exclusion Criteria: 
 
Recurrent hernias 
 
Defect size  > 5.0 cm 
 
Patient not giving consent 
 
Pregnant and lactating female 
 
Poor general condition 
 
Patient on anticoagulants 
 
Not fit for GA 
 
Patient with lateral hernias. 
 
Complicated hernias (e.g., strangulated, irreducible, obstructed) 
 
5. Study Arms and Interventions 
Arm A: eTEP-RS Technique 
Intervention: Laparoscopic retromuscular mesh repair using the enhanced view totally 
extraperitoneal (eTEP-RS) technique. 
Arm B: IPOM Plus Technique 
Intervention: Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial 
defect closure and mesh placement. 
6. Outcome Measures 
Primary Outcome: 
 
Pain score (VAS) at 24 hours post-op 
Secondary Outcomes: 
 
Operative time (minutes) 
 
Duration of hospital stay (days) 
 
Time to return to normal activity (days) 
 
Postoperative complications (within 30 days) 
 
Recurrence (at 6 months follow-up) 
7. Sample Size Calculation 
Based on a previous pilot study, a sample of 87 patients per group (total n=174) achieves 
80% power to detect a clinically significant difference in VAS score with a 5% level of 
significance. 

8. Randomization Method 
Simple randomization using odd- even method. 
9. Data Collection and Management 
Data will be recorded using standardized case record forms and entered into a secure 
password-protected database. Each participant will be assigned a unique ID to maintain 
confidentiality. 
10. Ethical Considerations 
The study has been approved by the Institutional Ethics Committee. Written informed 
consent will be obtained from all participants. 
11. IPD Sharing Statement 
De-identified individual participant data (IPD) and study documents will be made available 
upon reasonable request via email to the Principal Investigator. 
12. References 
1. Taşdelen HA. The extended-view totally extraperitoneal (eTEP) approach for incisional 
abdominal wall hernias: results from a single center. Surgical Endoscopy. 2022;36(6):4614-
23. 
2. Prakhar G, Parthasarathi R, Cumar B, Subbaiah R, Nalankilli VP, Praveen Raj P, et al. Extended 
View: Totally Extra Peritoneal (e-TEP) Approach for Ventral and Incisional Hernia-Early 
results from a single center. Surg Endosc. 2021;35(5):2005-13. 
3. Buenafe AA, Lee-Ong A. Lateral release in the repair of large ventral hernia. Annals of 
Laparoscopic and Endoscopic Surgery. 2019;4. 
4. Wiessner R, Vorwerk T, Tolla-Jensen C, Gehring A. Continuous Laparoscopic Closure of the 
Linea Alba with Barbed Sutures Combined with Laparoscopic Mesh Implantation (IPOM Plus 
Repair) As a New Technique for Treatment of Abdominal Hernias. Front Surg. 2017;4:62. 
5. Jani K. Laparoscopic intra-peritoneal onlay mesh plus repair for ventral abdominal wall 
hernias-is there substance to the hype. Mini-invasive Surg. 2018;2(5):14. 
6. Belyansky I, Daes J, Radu VG, Balasubramanian R, Reza Zahiri H, Weltz AS, et al. A novel 
approach using the enhanced-view totally extraperitoneal (eTEP) technique for laparoscopic 
retromuscular hernia repair. Surg Endosc. 2018;32(3):1525-32. 
 
 
STATISTICAL ANALYSIS PLAN (SAP) 
Primary Outcome: 
 
Comparison of VAS pain scores at 24 hours post-op between groups using 
independent sample t-test (if normally distributed) or Mann–Whitney U test (if 
non-parametric). 

Secondary Outcomes: 
 
Operative time, hospital stay, and return to activity: analyzed with t-tests or non-
parametric equivalents. 
 
Complications and recurrence rates: analyzed using Chi-square test or Fisher’s 
exact test. 
 
Confidence Intervals: 95% CI will be reported for mean differences and proportions. 
 
Significance level: p-value < 0.05 will be considered statistically significant. 
Software: Data will be analyzed using SPSS version XX or R software. 
Missing Data Handling: Intention-to-treat principle will be applied. Sensitivity analyses 
may be conducted based on missing patterns.