Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

NorthShore University HealthSystem

Status: Completed

Conditions: Inguinal Hernia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02062775

EH13-356

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

285 participants in 2 patient groups, including a placebo group

Self-Fixating Hernia Mesh

Active Comparator group

Description:

Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.

Treatment:

Procedure: Absorbable tacks may be used in hernias >2cm

Procedure: Use of self-fixating mesh for inguinal hernia repair

Non-Fixating Hernia Mesh

Placebo Comparator group

Description:

Non-fixating polyester mesh will be used for laparoscopic hernia repair.

Treatment:

Procedure: Use of non-fixating mesh for inguinal hernia repair