NCT02062775

Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

Detailed description

This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
PROCEDURE	Use of self-fixating mesh for inguinal hernia repair	Parietex ProGrip will be used to repair inguinal hernia
PROCEDURE	Use of non-fixating mesh for inguinal hernia repair	Parietex Anatomic mesh will be used to repair inguinal hernias.
PROCEDURE	Absorbable tacks may be used in hernias >2cm	Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures \>2cm

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-10-10
• Completion: 2017-10-10
• First posted: 2014-02-14
• Last updated: 2019-09-11

Locations

1 site across 1 country: United States