Comparison Between eTEP-RS vs IPOM PLUS

NCT07055464 | Completed DMC

• 1 other identifier: ETEPIPOM2024
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the outcomes of Enhanced View Totally Extraperitoneal Rives-Stoppa (eTEP-RS) repair and Intraperitoneal Onlay Mesh Plus (IPOM Plus) repair in the management of ventral wall hernias. The comparison includes operative time, post-operative pain, hospital stay, surgical site occurrences, and recurrence rates. Patients will be prospectively enrolled and allocated into two groups based on the surgeon's discretion or patient-specific criteria.

Conditions

Ventral Hernia Repair; Abdominal Hernia

Keywords

Etep-rs and ipom plus; Ventral hernia; Mesh repair

Outcome Measures

Primary Outcomes (2)

• Hernia Recurrence Rate

  Clinical or radiological evidence of hernia recurrence during follow-up.

  Up to 6 months post-surgery

• Postoperative Pain Score

  Postoperative pain will be assessed using the Visual Analogue Scale (VAS) 24 hours, and 7 days, 30 days and 6 months after surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Higher scores indicate a worse outcome.

  6 months

Secondary Outcomes (4)

• Operative Time

  Intraoperative

• Duration of Postoperative Hospital Stay

  DAY 1 TO DAY 15

• Incidence of Surgical Site Occurrences (SSOs)

  Within 30 days post-surgery

• Time to Return to Normal Activities

  Within 30 days postoperatively

Study Arms (2)

eTEP-RS Technique

EXPERIMENTAL

Patients undergoing laparoscopic abdominal wall hernia repair using the eTEP-RS (Enhanced View Totally Extraperitoneal-Retromuscular) technique.

Procedure: eTEP-RS Hernia Repair

IPOM Plus Technique

ACTIVE COMPARATOR

Patients undergoing laparoscopic abdominal wall hernia repair using the IPOM Plus technique with fascial defect closure.

Procedure: IPOM Plus Hernia Repair

Interventions

eTEP-RS Hernia Repair PROCEDURE

Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.

eTEP-RS Technique

IPOM Plus Hernia Repair PROCEDURE

Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.

IPOM Plus Technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient with uncomplicated ventral hernia with defect size between 2 cm and 5 cm
• Age between 18 years and 60 years.
• elective surgical cases(non emergency)

You may not qualify if:

• defect size greater than 5 cm.
• patient not giving consent.
• patient with lateral HERNIAS.
• patient with complicated ventral HERNIAS like irreducible , obstructed and strangulated HERNIAS.
• pregnant and lactating women.
• patient on anticoagulants.
• recurrent hernia.
• patient not fit for GA.
• POOR GENERAL CONDITION.

Sponsors & Collaborators

• GSVM Medical College: lead

Study Sites (1)

Gsvm Medical College Kanpur

Kanpur, Uttar Pradesh, 208002, India

Location

MeSH Terms

Conditions

Hernia, Abdominal; Hernia, Ventral

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Kavita Sijwali, MBBS, MS SURGERY RESIDENT

  GSVM MEDICAL COLLEGE KANPUR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident, DEPARTMENT OF GENERAL SURGERY

Model Details: Two-arm parallel group randomized controlled trial comparing eTEP-RS and IPOM Plus for elective abdominal wall hernia repair. Eligible participants are randomly assigned to one of the two surgical techniques. Both groups are followed in parallel to assess intraoperative, postoperative, and follow-up outcomes including pain, hospital stay, complications, and recurrence.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 9, 2025
• Study Start: February 23, 2024
• Primary Completion: February 23, 2025
• Study Completion: March 24, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after primary study completion date to 5 years after study completion
• Access Criteria: Qualified researchers, academicians, and clinicians may request access to de-identified individual participant data (IPD) and supporting information including the study protocol, informed consent form (ICF), and statistical analysis plan (SAP) after the primary results have been published. Access will be provided upon reasonable request submitted via email to the Principal Investigator. Requests must include a summary of the intended use and a data-sharing agreement to ensure compliance with confidentiality and ethical standards. No personally identifiable data will be shared. The information will be made available through secure institutional email correspondence or a protected data-sharing platform, subject to Institutional Ethics Committee approval if required.

Locations

IN (1)