Comparison Between eTEP-RS vs IPOM PLUS

GSVM Medical College

Status: Completed

Conditions: Ventral Hernia Repair; Abdominal Hernia

Treatments: Procedure: eTEP-RS Hernia Repair; Procedure: IPOM Plus Hernia Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07055464

ETEPIPOM2024

Details and patient eligibility

About

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.

Full description

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

Enrollment: 174 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

eTEP-RS Technique

Experimental group

Description:

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

Treatment:

Procedure: eTEP-RS Hernia Repair

IPOM Plus Technique

Active Comparator group

Description:

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

Treatment:

Procedure: IPOM Plus Hernia Repair