Clinical Trials Directory

Trials / Completed

CompletedNCT07055464

Comparison Between eTEP-RS vs IPOM PLUS

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
174 (actual)
Sponsor
GSVM Medical College · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

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

Conditions

Interventions

TypeNameDescription
PROCEDUREeTEP-RS Hernia RepairLaparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.
PROCEDUREIPOM Plus Hernia RepairIntraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.

Timeline

Start date
2024-02-23
Primary completion
2025-02-23
Completion
2025-03-24
First posted
2025-07-09
Last updated
2025-07-11

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT07055464. Inclusion in this directory is not an endorsement.