STAPLES VERSUS SUTURES FOR MESH FIXATION IN LICHTENSTEIN HERNIOPLASTY: A RANDOMIZED CONTROLLED TRIAL EVALUATING POSTOPERATIVE OUTCOMES IN INGUINAL HERNIA PATIENTS

May 30, 2026 updated by: Huzaif Saeed Khan
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The two techniques of mesh fixation include sutures and staples.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 74400
        • Sindh |nstitute of Urology and Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult male patients aged 18-75 years with uncomplicated unilateral inguinal hernia undergoing elective open Lichtenstein mesh repair

Exclusion Criteria:

  • Recurrent hernias
  • ASA (American Society of Anaesthesiologists) class III or greater
  • Patients with active obstructive lower urinary tract symptoms
  • Accidental per-operative nerve injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh fixation with staples
Procedure: Mesh fixation with Staples
2 staples will be applied directly over the pubic tubercle, while 3-4 staples will be used to fix the mesh over the inguinal ligament 1-2cm apart. Another 2-3 staples will secure the mesh to the conjoint tendon, and 1 staple lateral to the cord at the deep ring.
Active Comparator: Mesh fixation with sutures
Procedure: Mesh Fixation with Sutures
Polypropylene sutures will be used to fix the mesh, with continuous suturing over the pubic tubercle and inguinal ligament, and interrupted suturing along the posterior wall and deep ring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inguinodynia
Time Frame: 3 and 6 months postoperatively
Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain.
3 and 6 months postoperatively
Surgical site infection
Time Frame: within 30 days of surgery
Assessed using Southampton Surgical Site Infection grading system
within 30 days of surgery
Wound Hematoma
Time Frame: Within 30 days postoperatively
Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically
Within 30 days postoperatively
Wound Seroma
Time Frame: within 30 days postoperatively
Collection of clear fluid at the operative site, diagnosed clinically as a fluctuant, non-tender swelling at the surgical site
within 30 days postoperatively
Scrotal edema/hematoma
Time Frame: within 30 days postoperatively
Swelling or collection of fluid/blood in the scrotum, identified clinically
within 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: Within 6 months of surgery.
Clinically apparent swelling/bulge in the groin, diagnosed by clinical assessment, at the previously operated site
Within 6 months of surgery.
Operative time
Time Frame: During procedure
Time in minutes from skin incision to completion of skin closure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huzaif Saeed Khan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2026

Primary Completion (Estimated)

September 21, 2026

Study Completion (Estimated)

March 21, 2027

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIUT-ERC-2025/A-582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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