Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

December 8, 2014 updated by: Medical University of Vienna

A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.

A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.

Two techniques of inguinal hernia repair will be evaluated:

  1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
  2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

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

  • Austria
      • Feldkirch, Austria
        • LKH Feldkirch, Dept. of Surgery
      • Linz, Austria
        • Hospital Barmherzige Schwestern
      • Mistelbach, Austria
        • LK Weinviertel Mistelbach, Surgical Department
      • Vienna, Austria, 1170
        • KH Göttlicher Heiland
      • Vienna, Austria
        • KFJ Hospital, Dept. of Surgery
      • Vienna, Austria
        • Medical University of Vienna, Dept. of Surgery
      • Wiener Neustadt, Austria
        • KH Wiener Neustadt, Surgical Department

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary unilateral inguinal hernia
  • 18 years and older

Exclusion Criteria:

  • bilateral hernia
  • recurrent hernia
  • incarcerated hernia
  • malignant disease within the last 5 years
  • not able to understand the questionaire

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: selfgrip mesh
inguinal hernia repair using a selfgrip mesh
Active Comparator: 2
Procedure: lightweight mesh with suture fixation
inguinal hernia repair using a lightweight mesh with suture fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
chronic pain
Time Frame: 3 months, 15 months
3 months, 15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
morbidity
Time Frame: 3 months, 15 months
3 months, 15 months
recurrence rate
Time Frame: 3 months and 15 months
3 months and 15 months
quality of life
Time Frame: 3 months and 15 months
3 months and 15 months

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gerhard Prager, MD, Medical University of Vienna

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

January 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK MUW 613/2007

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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