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Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820131
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : December 9, 2014
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Inguinal Hernia Chronic Pain Procedure: selfgrip mesh Procedure: lightweight mesh with suture fixation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
Study Start Date : January 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. chronic pain [ Time Frame: 3 months, 15 months ]

Secondary Outcome Measures :
  1. morbidity [ Time Frame: 3 months, 15 months ]
  2. recurrence rate [ Time Frame: 3 months and 15 months ]
  3. quality of life [ Time Frame: 3 months and 15 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820131


Locations
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Austria
LKH Feldkirch, Dept. of Surgery
Feldkirch, Austria
Hospital Barmherzige Schwestern
Linz, Austria
LK Weinviertel Mistelbach, Surgical Department
Mistelbach, Austria
KH Göttlicher Heiland
Vienna, Austria, 1170
KFJ Hospital, Dept. of Surgery
Vienna, Austria
Medical University of Vienna, Dept. of Surgery
Vienna, Austria
KH Wiener Neustadt, Surgical Department
Wiener Neustadt, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gerhard Prager, MD Medical University of Vienna
More Information
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Responsible Party: Gerhard Prager, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00820131    
Other Study ID Numbers: EK MUW 613/2007
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: January 2009
Additional relevant MeSH terms:
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Chronic Pain
Hernia
Hernia, Inguinal
Pain
 Neurologic Manifestations
Pathological Conditions, Anatomical
Hernia, Abdominal