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

N/AEnrolling By InvitationNCT07627425

Huzaif Saeed Khan100 enrolled

Overview

The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.

The two techniques of mesh fixation include sutures and staples.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Inguinal Hernia Unilateral

Interventions

Mesh fixation with StaplesPROCEDURE

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.

Mesh Fixation with SuturesPROCEDURE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Sindh |nstitute of Urology and Transplantation

Karachi, Pakistan

Outcomes

Primary Outcomes

Inguinodynia

Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain.

Time frame: 3 and 6 months postoperatively

Surgical site infection

Assessed using Southampton Surgical Site Infection grading system

Time frame: within 30 days of surgery

Wound Hematoma

Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically

Time frame: Within 30 days postoperatively

Wound Seroma

Collection of clear fluid at the operative site, diagnosed clinically as a fluctuant, non-tender swelling at the surgical site

Time frame: within 30 days postoperatively

Scrotal edema/hematoma

Swelling or collection of fluid/blood in the scrotum, identified clinically

Time frame: within 30 days postoperatively

Secondary Outcomes

Hernia recurrence

Clinically apparent swelling/bulge in the groin, diagnosed by clinical assessment, at the previously operated site

Time frame: Within 6 months of surgery.

Operative time

Time in minutes from skin incision to completion of skin closure

Time frame: During procedure

Data from ClinicalTrials.gov

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