Randomised control trial comparing eTEP (extended totally extraperitoneal repair) vs IPOM (intraperitoneal onlay mesh) for ventral hernia repair.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain score on Post-operative Day 1 measured using Visual Analogue Scale.
Study Overview
Brief Summary
Title:
RANDOMISED CONTROL TRIAL COMPARING ETEP (EXTENDED TOTALLY EXTRAPERITONEAL REPAIR) VERSUS IPOM (INTRAPERITONEAL ONLAY MESH) FOR VENTRAL HERNIA REPAIR.
Introduction:
Ventral hernia repair still remains a significant challenge in surgery, with laparoscopic techniques having greatly evolved over time. IPOM and eTEP are two promising methods for hernia repair.
Aims:
To investigate the efficacy and safety of eTEP and IPOM approach in ventral hernia repair.
Objectives:
Primary objective is to compare immediate post-operative pain scores on POD1 (using VAS).
Secondary objectives is comparison of postoperative pain on Day 30 and 90, quality of life and other surgical site occurrences.
Methodology:
A single centre randomised control trial of duration one year will be conducted on 40 patients undergoing uncomplicated ventral hernia repair, having abdominal wall defect size within 2 to 7 cm, where 20 patients will be assigned to each IPOM and eTEP study groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patient above and including 18yrs of age.
- •Primary ventral or incisional hernia defect.
- •Hernia defect size greater than or equal to 2cm and lesser than or equal to 7cm.
- •Patient fit to tolerate General Anesthesia.
- •Patient eligible for repair via manual invasive procedure.
- •Should be able to give consent to participate in trial.
Exclusion Criteria
- •Hernia defect size more than 7cm and less than 2cm
- •Hernia defect require open surgical approach.
- •Recurrent hernia after repair by recto-rectus mesh placement.
- •Patient not willing to give consent.
- •Patient not fit for general anesthesia.
Outcomes
Primary Outcomes
Pain score on Post-operative Day 1 measured using Visual Analogue Scale.
Time Frame: Day 1
Secondary Outcomes
- Pain in post-operative period measured on follow-up at Day 30 & Day 90 using Visual Analogue Scale.(Day 30 & 90)
- Wound events such as surgical site infection (SSI) & surgical site occurrences requiring procedural intervention.(Till day 180)
- Abdominal wall-specific quality of life measured using Hernia-related quality of life survey(Day 180)
Investigators
Saptarshi Mondal
Indira Gandhi Institute of Medical Sciences, Patna