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

A Comparative Analysis of Polypropylene Conventional Mesh Fixation Versus 3-point Fixation Technique to Assess Post-Surgical Outcomes in Lichtenstein Hernia Repair (RCT).

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Complication,Postoperative; İnguinal Hernia
• Intervention / Treatment: Procedure: Conventional Mesh Fixation; Procedure: 3-point mesh fixation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Sindh Institute of urology and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Mesh Fixation Group (Standard Fixation; 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)	Procedure: Conventional Mesh Fixation; Patients in this group will undergo Lichtenstein tension-free hernia repair using a polypropylene mesh secured with the conventional technique. Multiple non-absorbable sutures will be placed across the inguinal floor to anchor the mesh between the transversalis fascia and the external oblique aponeurosis
Experimental: 3-Point Mesh Fixation Group (Minimal Fixation); 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)	Procedure: 3-point mesh fixation; Patients in this group will undergo Lichtenstein hernia repair with polypropylene mesh fixed at three key points only (pubic tubercle, inguinal ligament and conjoint tendon). The fixation points will be strategically chosen to provide sufficient stability while minimizing tissue trauma. Rationale: Reducing the number of fixation points is expected to decrease the risk of nerve entrapment, muscle irritation, and post-operative pain, without compromising mesh position or increasing recurrence rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute post operative pain	Acute Postoperative pain measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Standard analgesia (ketorolac 30 mg twice daily) will be provided.	7 days
wound infection	Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site	7- 14 days
Seroma	The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed.	7-14 days
hematoma	A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic groin pain	Pain persisting beyond three months post-surgery, measured using VAS and patient-reported impact on daily activities. Severity categorized as mild, moderate, or severe.	6 months
Hernia recurrence	Recurrence of previously repaired inguinal sweling/hernia clinically diagnosed by physical examination and confirmed with ultrasound.	6 months

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: inguinal hernia; comparision; lichtenstein mesh repair; 3-point fixation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hernia, Inguinal; Postoperative Complications
• Other Study ID Numbers: SIUT-ERC-2025/A-573

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No