CClinicalTrials.gg
CompletedNCT07334548COMETUpdated Jun 4, 2026

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

An interventional study of 3-point mesh fixation and Conventional Mesh Fixation in İnguinal Hernia, Complication,Postoperative and Pain, Postoperative, sponsored by Sahar Mughis. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Sahar Mughis · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • İnguinal Hernia
  • Complication,Postoperative
  • Pain, Postoperative

Keywords

  • comparision
  • lichtenstein mesh repair
  • 3-point fixation
  • inguinal hernia
03

In context

Hernia, Inguinal

549 studies on the registry are indexed under Hernia, Inguinal; 74 are open to participants now.

This study's enrollment of 64 is below the median of 90 across 406 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

This is the only study on the registry with Sahar Mughis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedure3-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

  • ProcedureConventional 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

  2. wound infection

    Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site

    Time frame: 7- 14 days

  3. Seroma

    The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed.

    Time frame: 7-14 days

  4. hematoma

    A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. Hernia recurrence

    Recurrence of previously repaired inguinal sweling/hernia clinically diagnosed by physical examination and confirmed with ultrasound.

    Time frame: 6 months

07

Study locations

1 site
  • Sindh Institute of Urology and Transplantation
    Karachi, Sindh 74200, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07334548
Lead sponsor
Sahar Mughis
Collaborators
Sindh Institute of Urology and Transplantation
Responsible party
Sahar Mughis (Postgraduate Trainee, Sindh Institute of Urology and Transplantation) — Sponsor-investigator
First posted
Jan 12, 2026
Start date
Sep 15, 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026
Last update
Jun 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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