Clinical Trial

Prospective, Randomized, Controlled Trial Comparing Self-Gripping and Conventional Mesh in Laparoscopic Totally Extra Peritoneal Inguinal Hernia Repair

Completed
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Summary
This study is a single-center, prospective, randomized controlled trial designed to compare clinical outcomes between self-gripping mesh and conventional mesh with limited tacker fixation in laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. Adult patients diagnosed with inguinal hernia and scheduled for laparoscopic TEP repair are randomly assigned to receive either a self-gripping mesh (Progrip™) or a conventional mesh fixed with a single permanent tacker to the pubic bone (Parietex™). Both meshes are commonly used in clinical practice and approved for inguinal hernia repair. The primary objective of this study is to evaluate postoperative discomfort and quality of life following surgery. Outcomes are assessed using validated patient-reported questionnaires, including the Carolina Comfort Scale (CCS) and the International Prostate Symptom Score (IPSS). Secondary outcomes include postoperative complications, physical examination findings such as local induration or tenderness, operative time, and short-term hernia recurrence. Patients are followed at 1 week, 3 weeks, and 3 months after surgery. The results of this study aim to provide comparative evidence regarding the safety and short-term clinical outcomes of self-gripping versus tacker-fixed conventional mesh in laparoscopic TEP inguinal hernia repair.
Trial Details
NCT Number NCT07350187
Lead Sponsor Chungnam National University Hospital
Conditions Inguinal Hernias
Enrollment 95 participants
Start Date 2024-10-22
Primary Completion 2025-10-14 (estimated)
Study Completion 2025-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-01-20