NCT07350187

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Chungnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernias

Interventions

Type	Name	Description
DEVICE	Self-gripping mesh (Progrip™)	self-gripping surgical mesh used during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. The mesh adheres to surrounding tissue via resorbable microgrips and does not require additional fixation devices.
DEVICE	Conventional mesh with tacker fixation (Parietex™)	A conventional surgical mesh used during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. The mesh is fixed with a single permanent tacker placed on the pubic bone to ensure mesh stability.

Timeline

• Start date: 2024-10-22
• Primary completion: 2025-10-14
• Completion: 2025-10-14
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study