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NCT02062775 Clinical Trial

Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02062775
Other study ID # EH13-356
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date October 10, 2017

Study information
Verified date September 2019
Source NorthShore University HealthSystem
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 285
Est. completion date October 10, 2017
Est. primary completion date October 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Use of self-fixating mesh for inguinal hernia repair
Parietex ProGrip will be used to repair inguinal hernia
• Use of non-fixating mesh for inguinal hernia repair
Parietex Anatomic mesh will be used to repair inguinal hernias.
• 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

Locations
Country Name City State
United States NorthShore University HealthSystem Evanston Illinois

Sponsors (2)
Lead Sponsor Collaborator
NorthShore University HealthSystem Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Post-Op adverse events related to mesh 1 year
Other Post-Op quality of life and pain scores 1 year
Primary Chronic postoperative pain 1 year
Secondary Incidence of hernia recurrence 1 year
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