ClinicalTrials.gg
CompletedNCT07055464Updated Jul 11, 2025

Comparison Between eTEP-RS vs IPOM PLUS

An interventional study of eTEP-RS Hernia Repair and IPOM Plus Hernia Repair in Ventral Hernia Repair and Abdominal Hernia, sponsored by GSVM Medical College. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-11.

Primary conditionHernia, VentralRegistry: Hernia, AbdominalReclassifiedWhy we changed it
Registry
Hernia, Abdominal — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hernia, Ventral
Why
  1. The study's listed conditions name Hernia, Ventral, a narrower term within Hernia, Abdominal.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by GSVM Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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

02

Conditions studied

  • Ventral Hernia Repair
  • Abdominal Hernia

Browse trials for

Keywords

  • Etep-rs and ipom plus
  • Ventral hernia
  • Mesh repair
03

In context

Hernia, Ventral Reclassified

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's enrollment of 174 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

GSVM Medical College is the lead sponsor of 6 studies on the registry; none are open to participants now.

Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Abdominal. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (actual)

Study arms

  • Experimental
    eTEP-RS Technique

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

    Procedure: eTEP-RS Hernia Repair

  • Active comparator
    IPOM Plus Technique

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

    Procedure: IPOM Plus Hernia Repair

Interventions

  • ProcedureeTEP-RS Hernia Repair

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

  • ProcedureIPOM Plus Hernia Repair

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

06

What researchers measure

Primary outcomes

  1. Hernia Recurrence Rate

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

    Time frame: Up to 6 months post-surgery

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. Operative Time

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

    Time frame: Intraoperative

  2. Duration of Postoperative Hospital Stay

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

    Time frame: DAY 1 TO DAY 15

  3. Incidence of Surgical Site Occurrences (SSOs)

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

    Time frame: Within 30 days post-surgery

  4. Time to Return to Normal Activities

    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.

    Time frame: Within 30 days postoperatively

07

Study locations

1 site
  • Gsvm Medical College Kanpur
    Kanpur, Uttar Pradesh 208002, India
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The Inpatient Department (IPD) of the Department of General Surgery is used by multiple researchers. However, patients eligible for this study will be screened using a separate screening log. Only patients meeting the inclusion criteria and providing informed written consent will be enrolled. No overlap in participant enrollment with other interventional trials will occur. Ethical clearance has been obtained and institutional guidelines for shared clinical spaces will be followed.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

Data sharing details ↗ · notapplicable.example.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07055464
Lead sponsor
GSVM Medical College
Responsible party
Kavita Sijwali (Junior resident, DEPARTMENT OF GENERAL SURGERY, GSVM Medical College) — Principal investigator
First posted
Jul 9, 2025
Start date
Feb 23, 2024
Primary completion
Feb 23, 2025
Completion
Mar 24, 2025
Last update
Jul 11, 2025

Study contacts

Kavita Sijwali, MBBS, MS SURGERY RESIDENT
principal investigator · GSVM MEDICAL COLLEGE KANPUR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion