Chronic Pain After Inguinal Hernia Repair (GRIP-ME)
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ClinicalTrials.gov Identifier: NCT00820131 |
Recruitment Status :
Completed
First Posted : January 9, 2009
Last Update Posted : December 9, 2014
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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:
- open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
- 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 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 |

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 |
- chronic pain [ Time Frame: 3 months, 15 months ]
- morbidity [ Time Frame: 3 months, 15 months ]
- recurrence rate [ Time Frame: 3 months and 15 months ]
- quality of life [ Time Frame: 3 months and 15 months ]

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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 |
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

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
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 |
Principal Investigator: | Gerhard Prager, MD | Medical University of Vienna |
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 |
Chronic Pain Hernia Hernia, Inguinal Pain |
Neurologic Manifestations Pathological Conditions, Anatomical Hernia, Abdominal |