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

Chungnam National University Hospital

Status: Completed

Conditions: Inguinal Hernias

Treatments: Device: Conventional mesh with tacker fixation (Parietex™); Device: Self-gripping mesh (Progrip™)

Study type: Interventional

Funder types: Other

Identifiers

NCT07350187

TEP001

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adults aged 19 to 100 years Diagnosed with inguinal hernia Scheduled to undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair Able to understand the study procedures and provide written informed consent

Exclusion criteria

Patients receiving immunosuppressive therapy or with immune-related diseases Patients with urological conditions requiring urinary catheterization preoperatively or intraoperatively Patients with complicated inguinal hernia, including irreducible hernia or hernia associated with bowel injury Patients with unintended intraoperative injury during surgery Pregnant women or women of childbearing potential without confirmed non-pregnant status Patients who decline to participate or withdraw informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Self-gripping mesh (Progrip™)

Experimental group

Description:

Participants assigned to this arm undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair using a self-gripping mesh (Progrip™). The mesh is positioned in the preperitoneal space without the use of additional fixation devices, relying on its microgrip technology for adherence. All other aspects of the surgical procedure are standardized.

Treatment:

Device: Self-gripping mesh (Progrip™)

Conventional mesh with tacker fixation (Parietex™)

Active Comparator group

Description:

Participants assigned to this arm undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair using a conventional mesh (Parietex™). The mesh is fixed with a single permanent tacker placed on the pubic bone to ensure mesh stability. No fixation is applied to muscle or nerve-bearing areas. All other aspects of the surgical procedure are standardized.

Treatment:

Device: Conventional mesh with tacker fixation (Parietex™)