Chronic Pain After Inguinal Hernia Repair (GRIP-ME)

This study has been completed.
Information provided by:
Medical University of Vienna Identifier:
First received: January 8, 2009
Last updated: December 8, 2014
Last verified: January 2009

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
Study Completion Date: December 2014
Primary Completion Date: January 2013 (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


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

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
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Please refer to this study by its identifier: NCT00820131

LKH Feldkirch, Dept. of Surgery
Feldkirch, Austria
Hospital Barmherzige Schwestern
Linz, Austria
LK Weinviertel Mistelbach, Surgical Department
Mistelbach, Austria
KFJ Hospital, Dept. of Surgery
Vienna, Austria
KH Göttlicher Heiland
Vienna, Austria, 1170
Medical University of Vienna, Dept. of Surgery
Vienna, Austria
KH Wiener Neustadt, Surgical Department
Wiener Neustadt, Austria
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Gerhard Prager, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Prager, MD, Medical University of Vienna Identifier: NCT00820131     History of Changes
Other Study ID Numbers: EK MUW 613/2007
Study First Received: January 8, 2009
Last Updated: December 8, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Chronic Pain
Hernia, Inguinal
Hernia, Abdominal
Nervous System Diseases
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms processed this record on October 13, 2015