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

NCT07334548 | Enrolling By Invitation

• 1 other identifier: SIUT-ERC-2025/A-573
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

İnguinal Hernia; Complication,Postoperative; Pain, Postoperative

Keywords

comparision; lichtenstein mesh repair; 3-point fixation; inguinal hernia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Chronic groin pain

  6 months

• Hernia recurrence

  6 months

Study Arms (2)

Conventional Mesh Fixation Group (Standard Fixation

ACTIVE COMPARATOR

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

3-Point Mesh Fixation Group (Minimal Fixation)

EXPERIMENTAL

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

Interventions

3-point mesh fixation PROCEDURE

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

3-Point Mesh Fixation Group (Minimal Fixation)

Conventional Mesh Fixation PROCEDURE

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

Conventional Mesh Fixation Group (Standard Fixation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal; Postoperative Complications; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 12, 2026
• Study Start: September 15, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

PA (1)