Comparison Between eTEP-RS vs IPOM PLUS

NCT ID: NCT07055464

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2025-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Abdominal wall hernias are common surgical conditions, and multiple techniques have evolved for their repair. eTEP-RS is a relatively newer, minimally invasive approach that combines the principles of the Rives-Stoppa retromuscular mesh placement with the benefits of laparoscopic surgery. IPOM Plus, on the other hand, is a widely practiced technique involving intraperitoneal mesh placement with defect closure.

This prospective comparative study is designed to evaluate the effectiveness and safety of eTEP-RS versus IPOM Plus in patients undergoing elective repair of ventral or incisional hernias. The study will assess intra-operative parameters (e.g., duration of surgery, blood loss), early post-operative outcomes (pain score, duration of hospital stay), surgical site complications (seroma, infection, mesh-related issues), and long-term outcomes (recurrence, quality of life).

Patients fulfilling inclusion criteria will be assigned to one of the two arms. Standardized protocols will be followed for pre-operative work-up, anesthesia, surgical steps, and post-operative care. Data will be analyzed to determine if one technique offers superior clinical outcomes, better patient satisfaction, or reduced recurrence

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventral Hernia Repair Abdominal Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eTEP-RS Technique

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

Group Type EXPERIMENTAL

eTEP-RS Hernia Repair

Intervention Type PROCEDURE

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

IPOM Plus Technique

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

Group Type ACTIVE_COMPARATOR

IPOM Plus Hernia Repair

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eTEP-RS Hernia Repair

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

Intervention Type PROCEDURE

IPOM Plus Hernia Repair

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GSVM Medical College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kavita Sijwali

Junior resident, DEPARTMENT OF GENERAL SURGERY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kavita Sijwali, MBBS, MS SURGERY RESIDENT

Role: PRINCIPAL_INVESTIGATOR

GSVM MEDICAL COLLEGE KANPUR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gsvm Medical College Kanpur

Kanpur, Uttar Pradesh, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETEPIPOM2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laparoscopic Inguinal Hernia Repair TEP vs TAPP
NCT07108972 ACTIVE_NOT_RECRUITING NA
Treating Parastomal Hernia With a Mesh
NCT02233465 COMPLETED PHASE1/PHASE2