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

Comparative Study of Staples Versus Polypropylene Sutures for Mesh Fixation in Lichenstein's Tension-free Inguinal Hernia Repair in Terms of Postoperative Pain

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Staples for mesh fixation; Procedure: Polypropylene suture for mesh fixation

Detailed Description

Inguinal hernia repair is one of the most common general surgical procedures worldwide. The standard method for mesh fixation during Lichtenstein tension-free hernioplasty uses polypropylene sutures. However, skin staples have recently been introduced as a faster and potentially less painful alternative. This randomized controlled trial compares both methods in terms of postoperative pain, measured using the Visual Analogue Scale (VAS), and operative time.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Jinnah Postgraduate Medical Centre

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staples for mesh fixation; Mesh secured with stainless steel staples during Lichenstein tension-free inguinal hernioplasty	Procedure: Staples for mesh fixation; Mesh secured using stainless steel staples in Lichenstein tension-free inguinal hernioplasty
Active Comparator: Polypropylene Suture Group; Mesh secured with polypropylene sutures during Lichensteins tension-free inguinal hernioplasty	Procedure: Polypropylene suture for mesh fixation; Mesh secured using polypropylene sutures in Lichenstein tension-free inguinal hernioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time (minutes)	Time in minutes from initiation of mesh fixation to completion of skin closure	During Surgery (intraoperative period)

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Collaborators: College of Physicians and Surgeons Pakistan
• Investigators: Principal Investigator: Shafqatullah, Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): March 28, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: postoperative pain; mesh fixation; staples; hernioplasty; Lichensteins repair; polypropylene sutures
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hernia, Inguinal; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures
• Other Study ID Numbers: JPMC-GS-2025-12507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will not share individual participant data. Only aggregated results will be published. Data will remain confidential as per institutional policy and ethical approval requirements

Drug and device information, study documents

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