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Completed

NCT Number: NCT07055464

Comparison Between eTEP-RS vs IPOM PLUS

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gsvm Medical College Kanpur

Kanpur, Uttar Pradesh, 208002, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eTEP-RS Hernia Repair

Procedure

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

IPOM Plus Hernia Repair

Procedure

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

Primary outcomes

  1. Hernia Recurrence Rate

    Time frame: Up to 6 months post-surgery

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

  2. Postoperative Pain Score

    Time frame: 6 months

    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.

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperative

    Time from first incision to final closure, measured in minutes.

  2. Duration of Postoperative Hospital Stay

    Time frame: DAY 1 TO DAY 15

    Number of days from surgery to discharge(upto 15 days post- operatively)

  3. Incidence of Surgical Site Occurrences (SSOs)

    Time frame: Within 30 days post-surgery

    Includes wound infection, seroma, hematoma, or mesh-related complications occurring within 30 days

  4. Time to Return to Normal Activities

    Time frame: Within 30 days postoperatively

    Number of days taken by the patient to resume routine daily activities, such as walking without support, household tasks, or returning to work, as reported during follow-up.

Sponsors and collaborators

Lead sponsor

GSVM Medical College

Other

Registry information

Official study title

Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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