STAPLES VERSUS SUTURES FOR MESH FIXATION IN LICHTENSTEIN HERNIOPLASTY: A RANDOMIZED CONTROLLED TRIAL EVALUATING POSTOPERATIVE OUTCOMES IN INGUINAL HERNIA PATIENTS
1 other identifier
interventional
100
1 country
1
Brief Summary
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2026
CompletedFirst Submitted
Initial submission to the registry
May 30, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 21, 2027
June 4, 2026
May 1, 2026
6 months
May 30, 2026
May 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Inguinodynia
Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain.
3 and 6 months postoperatively
Surgical site infection
Assessed using Southampton Surgical Site Infection grading system
within 30 days of surgery
Wound Hematoma
Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically
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
within 30 days postoperatively
Scrotal edema/hematoma
Swelling or collection of fluid/blood in the scrotum, identified clinically
within 30 days postoperatively
Secondary Outcomes (2)
Hernia recurrence
Within 6 months of surgery.
Operative time
During procedure
Study Arms (2)
Mesh fixation with staples
EXPERIMENTALMesh fixation with sutures
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- Adult male patients aged 18-75 years with uncomplicated unilateral inguinal hernia undergoing elective open Lichtenstein mesh repair
You may not qualify if:
- Recurrent hernias
- ASA (American Society of Anaesthesiologists) class III or greater
- Patients with active obstructive lower urinary tract symptoms
- Accidental per-operative nerve injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sindh |nstitute of Urology and Transplantation
Karachi, 74400, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Postgraduate Trainee
Study Record Dates
First Submitted
May 30, 2026
First Posted
June 4, 2026
Study Start
March 21, 2026
Primary Completion (Estimated)
September 21, 2026
Study Completion (Estimated)
March 21, 2027
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share