Comparing Staples Versus Polypropylene Sutures for Mesh Fixation in Inguinal Hernia Repair in Terms of Postoperative Pain

NCT07261189 | Recruiting

• 1 other identifier: JPMC-GS-2025-12507
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.

Conditions

Inguinal Hernia

Keywords

Lichensteins repair; staples; polypropylene sutures; mesh fixation; postoperative pain; hernioplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative pain (VAS score)

  Pain intensity will be measured using the Visual Analogue Scale (VAS 0-10)

  Postoperative day 1, day 7 and day 30

Secondary Outcomes (1)

• Operative time (minutes)

  During Surgery (intraoperative period)

Study Arms (2)

Staples for mesh fixation

EXPERIMENTAL

Mesh secured with stainless steel staples during Lichenstein tension-free inguinal hernioplasty

Procedure: Staples for mesh fixation

Polypropylene Suture Group

ACTIVE COMPARATOR

Mesh secured with polypropylene sutures during Lichensteins tension-free inguinal hernioplasty

Procedure: Polypropylene suture for mesh fixation

Interventions

Staples for mesh fixation PROCEDURE

Mesh secured using stainless steel staples in Lichenstein tension-free inguinal hernioplasty

Staples for mesh fixation

Polypropylene suture for mesh fixation PROCEDURE

Mesh secured using polypropylene sutures in Lichenstein tension-free inguinal hernioplasty

Polypropylene Suture Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients aged 20 to 60 years.
• Patients undergoing elective Lichtenstein tension-free mesh repair for unilateral, uncomplicated inguinal hernia (direct or indirect).
• Body Mass Index (BMI) between 19 and 30 kg/m².
• ASA physical status I, II, or III.
• Patients willing to participate and provide informed consent.

You may not qualify if:

• Diabetic patients (on medical records).
• Bilateral or recurrent inguinal hernia.
• Complicated hernia (irreducible, obstructed, or strangulated).
• Patients unwilling to participate or who fail to complete follow-up.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead
• College of Physicians and Surgeons Pakistan: collaborator

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Sutures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Shafqatullah

  Jinnah Postgraduate Medical Centre, Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asna Ursani, MBBS, FCPS Trainee

CONTACT

+923337885237; asnaursani@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, FCPS Trainee

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)