Post-Surgical Outcomes of Conventional vs 3-Point Mesh Fixation in Lichtenstein Repair: An RCT (COMET)

Sindh Institute of Urology and Transplantation

Status: Invitation-only

Conditions: İnguinal Hernia; Pain, Postoperative; Complication,Postoperative

Treatments: Procedure: 3-point mesh fixation; Procedure: Conventional Mesh Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT07334548

SIUT-ERC-2025/A-573

Details and patient eligibility

About

This is a single-center, parallel-group randomized controlled trial conducted in 2025-2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. This study shows the comparative analysis of polypropylene conventional mesh fixation versus 3-point fixation technique to assess Post-Surgical Outcomes in Lichtenstein Hernia Repair

Full description

This randomized controlled trial is designed to compare the outcomes of conventional mesh fixation versus 3-point fixation in patients undergoing Lichtenstein inguinal hernia repair. The primary focus is to evaluate immediate postoperative outcomes-pain, seroma, hematoma, and wound infection-on postoperative days 1 and 7. Long-term outcomes, including recurrence and chronic groin pain, will be assessed at 3 months and 6 months. The study will include 64 patients aged 18-70 years, meeting ASA I-II criteria, and presenting with unilateral inguinal hernia. They will be randomly assigned to one of the two fixation techniques under a single-blind design where only the patient is blinded.

Data will be collected using a structured proforma capturing demographics, perioperative findings, and postoperative follow-up information. Pain will be measured using the Visual Analog Scale (VAS) with standardized analgesia. Data analysis will be performed using SPSS, with appropriate statistical tests applied according to the nature of the variables. A significance level of p < 0.05 will be used.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients presenting to the outpatient department with unilateral inguinal hernia requiring Lichtenstein repair

Age between 18-70 years Both male and female ASA I-II

Exclusion criteria

Recurrent, bilateral, complicated, or incisional hernia Patients with pre-existing obstructive LUTS Chronic kidney disease (CKD), patients on hemodyalysis. Chronic liver disease (CLD)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Conventional Mesh Fixation Group (Standard Fixation

Active Comparator group

Description:

Lichtenstein inguinal hernia repair with polypropylene mesh fixed using the conventional technique (multiple non-absorbable sutures across the inguinal floor) to measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up)

Treatment:

Procedure: Conventional Mesh Fixation

3-Point Mesh Fixation Group (Minimal Fixation)

Experimental group

Description:

Lichtenstein inguinal hernia repair with polypropylene mesh fixed at only three strategic points to minimize tissue trauma. To measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up)

Treatment:

Procedure: 3-point mesh fixation