Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Use of non-fixating mesh for inguinal hernia repair; Procedure: Use of self-fixating mesh for inguinal hernia repair; Procedure: Absorbable tacks may be used in hernias >2cm

• Registration Number: NCT02062775
• Lead Sponsor: NorthShore University HealthSystem

Brief 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• > 18 years
• ASA Classification I, II, III
• scheduled for elective TEP inguinal hernia repair

Exclusion Criteria

• ASA Classification IV or greater
• needing emergency surgery
• known history of narcotic dependence
• undergoing bilateral inguinal or combined umbilical hernia repair
• undergoing other procedures during same anesthetic
• undergoing recurrent inguinal hernia repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Fixating Hernia Mesh	Absorbable tacks may be used in hernias >2cm	Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
Non-Fixating Hernia Mesh	Use of non-fixating mesh for inguinal hernia repair	Non-fixating polyester mesh will be used for laparoscopic hernia repair.
Self-Fixating Hernia Mesh	Use of self-fixating mesh for inguinal hernia repair	Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.

Primary Outcome Measures

Name	Time	Method
Chronic postoperative pain	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of hernia recurrence	1 year

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States