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

NCT ID: NCT07261189

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Staples for mesh fixation

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

Group Type EXPERIMENTAL

Staples for mesh fixation

Intervention Type PROCEDURE

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

Polypropylene Suture Group

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

Group Type ACTIVE_COMPARATOR

Polypropylene suture for mesh fixation

Intervention Type PROCEDURE

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

Interventions

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Staples for mesh fixation

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

Intervention Type PROCEDURE

Polypropylene suture for mesh fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role collaborator

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Asna Ursani

MBBS, FCPS Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shafqatullah

Role: PRINCIPAL_INVESTIGATOR

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Locations

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Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Asna Ursani, MBBS, FCPS Trainee

Role: CONTACT

+923337885237

Facility Contacts

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Asna Ursani, MBBS, FCPS Trainee

Role: primary

+923337885237

Other Identifiers

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JPMC-GS-2025-12507

Identifier Type: -

Identifier Source: org_study_id

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