Enrolling by invitation NCT07627425
STAPLES VERSUS SUTURES FOR MESH FIXATION IN LICHTENSTEIN HERNIOPLASTY: A RANDOMIZED CONTROLLED TRIAL EVALUATING POSTOPERATIVE OUTCOMES IN INGUINAL HERNIA PATIENTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mesh fixation with Staples, Mesh Fixation with Sutures.
- Who it may be relevant to
- Registry conditions: Inguinal Hernia Unilateral. Basic parameters: 18 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.
Detailed description
The two techniques of mesh fixation include sutures and staples.
Interventions
- Procedure Mesh fixation with Staples
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. - Procedure Mesh Fixation with Sutures
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 outcome measures
- Inguinodynia [Time frame: 3 and 6 months postoperatively]
- Surgical site infection [Time frame: within 30 days of surgery]
- Wound Hematoma [Time frame: Within 30 days postoperatively]
- Wound Seroma [Time frame: within 30 days postoperatively]
- Scrotal edema/hematoma [Time frame: within 30 days postoperatively]
Secondary outcome measures (2)
- Hernia recurrence [Time frame: Within 6 months of surgery.]
- Operative time [Time frame: During procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Sindh |nstitute of Urology and Transplantation — Karachi
Identifiers
NCT: NCT07627425 · SIUT-ERC-2025/A-582