Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00820131
First received: January 8, 2009
Last updated: February 24, 2011
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Inguinal Hernia
Chronic Pain
Procedure: selfgrip mesh
Procedure: lightweight mesh with suture fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • chronic pain [ Time Frame: 3 months, 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity [ Time Frame: 3 months, 15 months ] [ Designated as safety issue: No ]
  • recurrence rate [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months and 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820131

Contacts
Contact: Gerhard Prager, MD +43 1 40400 5621 gerhard.prager@meduniwien.ac.at
Contact: Erwin Rieder, MD +43 1 40400 5621 erwin.rieder@meduniwien.ac.at

Locations
Austria
LKH Feldkirch, Dept. of Surgery Recruiting
Feldkirch, Austria
Contact: Etienne Wenzl, MD       etienne.wenzl@lkhf.at   
Sub-Investigator: Peter Tschann, MD         
Principal Investigator: Etienne Wenzl, MD         
Hospital Barmherzige Schwestern Recruiting
Linz, Austria
Contact: Martin Aufschnaiter, MD       martin.aufschnaiter@bhs.at   
Sub-Investigator: Thomas Burgstaller, MD         
Principal Investigator: Martin Aufschnaiter, MD         
LK Weinviertel Mistelbach, Surgical Department Completed
Mistelbach, Austria
Medical University of Vienna, Dept. of Surgery Completed
Vienna, Austria
KH Göttlicher Heiland Recruiting
Vienna, Austria, 1170
Contact: Viktor Grablowitz, MD         
Sub-Investigator: Alexander Butz, MD         
Principal Investigator: Viktor Grablowitz, MD         
KFJ Hospital, Dept. of Surgery Recruiting
Vienna, Austria
Contact: Josef Karner, MD       josef.karner@wienkav.at   
Principal Investigator: Sabine Thalhammer, MD         
Principal Investigator: Josef Karner, MD         
KH Wiener Neustadt, Surgical Department Recruiting
Wiener Neustadt, Austria
Contact: Friedrich Längle, MD    +43 2622 321-0    friedrich.laengle@wienerneustadt.lknoe.at   
Principal Investigator: Herwig Pokorny, MD         
Principal Investigator: Friedrich Längle, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Prager, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Prager, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00820131     History of Changes
Other Study ID Numbers: EK MUW 613/2007
Study First Received: January 8, 2009
Last Updated: February 24, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014