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
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
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
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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:
- 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 | 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 May 23, 2013