Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
250 participants
INTERVENTIONAL
2008-01-31
2014-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
selfgrip mesh
inguinal hernia repair using a selfgrip mesh
2
lightweight mesh with suture fixation
inguinal hernia repair using a lightweight mesh with suture fixation
Interventions
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selfgrip mesh
inguinal hernia repair using a selfgrip mesh
lightweight mesh with suture fixation
inguinal hernia repair using a lightweight mesh with suture fixation
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
Exclusion Criteria
* recurrent hernia
* incarcerated hernia
* malignant disease within the last 5 years
* not able to understand the questionaire
18 Years
85 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Medical University of Vienna
Principal Investigators
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Gerhard Prager, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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LKH Feldkirch, Dept. of Surgery
Feldkirch, , Austria
Hospital Barmherzige Schwestern
Linz, , Austria
LK Weinviertel Mistelbach, Surgical Department
Mistelbach, , Austria
KH Göttlicher Heiland
Vienna, , Austria
KFJ Hospital, Dept. of Surgery
Vienna, , Austria
Medical University of Vienna, Dept. of Surgery
Vienna, , Austria
KH Wiener Neustadt, Surgical Department
Wiener Neustadt, , Austria
Countries
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Other Identifiers
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EK MUW 613/2007
Identifier Type: -
Identifier Source: org_study_id