Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

September 9, 2019 updated by: NorthShore University HealthSystem

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-Fixating Hernia Mesh
Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
Procedure: Use of self-fixating mesh for inguinal hernia repair
Parietex ProGrip will be used to repair inguinal hernia
Other Names:
  • Parietex ProGrip
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
Placebo Comparator: Non-Fixating Hernia Mesh
Non-fixating polyester mesh will be used for laparoscopic hernia repair.
Procedure: Use of non-fixating mesh for inguinal hernia repair
Parietex Anatomic mesh will be used to repair inguinal hernias.
Other Names:
  • Parietex Anatomic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chronic postoperative pain
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hernia recurrence
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Post-Op adverse events related to mesh
Time Frame: 1 year
1 year
Post-Op quality of life and pain scores
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: John Linn, MD, NorthShore University HealthSystem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 10, 2017

Study Completion (Actual)

October 10, 2017

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH13-356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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