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NCT Number: NCT07627425

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

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

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Key information

Conditions

Inguinal Hernia Unilateral Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sindh |nstitute of Urology and Transplantation

Karachi, 74400, Pakistan

About this study

The two techniques of mesh fixation include sutures and staples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesh fixation with Staples

Procedure

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 Sutures

Procedure

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.

Primary outcomes

  1. 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.

  2. Surgical site infection

    Time frame: within 30 days of surgery

    Assessed using Southampton Surgical Site Infection grading system

  3. Wound Hematoma

    Time frame: Within 30 days postoperatively

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

  4. 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

  5. Scrotal edema/hematoma

    Time frame: within 30 days postoperatively

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

Secondary outcomes

  1. 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

  2. Operative time

    Time frame: During procedure

    Time in minutes from skin incision to completion of skin closure

Sponsors and collaborators

Lead sponsor

Huzaif Saeed Khan

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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