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.
Sponsored by GSVM Medical College · Not applicable, Interventional, and Treatment
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.
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
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 →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 →
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.
Exclusion Criteria:
Patients undergoing laparoscopic abdominal wall hernia repair using the eTEP-RS (Enhanced View Totally Extraperitoneal-Retromuscular) technique.
Procedure: eTEP-RS Hernia Repair
Patients undergoing laparoscopic abdominal wall hernia repair using the IPOM Plus technique with fascial defect closure.
Procedure: IPOM Plus Hernia Repair
Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.
Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.
Hernia Recurrence Rate
Clinical or radiological evidence of hernia recurrence during follow-up.
Time frame: 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.
Time frame: 6 months
Operative Time
Time from first incision to final closure, measured in minutes.
Time frame: Intraoperative
Duration of Postoperative Hospital Stay
Number of days from surgery to discharge(upto 15 days post- operatively)
Time frame: DAY 1 TO DAY 15
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
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
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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