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| Sponsored by: |
Medical University of Vienna |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00820131 |
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:
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-Mesh |
| 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 |
|---|---|
| 1: Experimental |
Procedure: selfgrip mesh
inguinal hernia repair using a selfgrip mesh
|
| 2: Active Comparator |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| Austria | |
| Medical University of Vienna, Dept. of Surgery | Recruiting |
| Vienna, Austria | |
| Contact: Gerhard Prager, MD +43 1 40400 5621 gerhard.prager@meduniwien.ac.at | |
| Principal Investigator: Erwin Rieder, MD | |
| Sub-Investigator: Andrea Dal Borgo, MD | |
| Sub-Investigator: Stefan Riss, MD | |
| LK Weinviertel Mistelbach, Surgical Department | Recruiting |
| Mistelbach, Austria | |
| Contact: Georg Reiner, MD +43 2572 3341-4680 georg.reiner@mistelbach.lknoe.at | |
| Principal Investigator: Thomas Inhauser, MD | |
| Principal Investigator: Georg Heurteur, 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: | Gerhard Prager, MD | Medical University of Vienna |
More Information
| Responsible Party: | Medical University of Vienna ( Gerhard Prager, MD ) |
| Study ID Numbers: | Austrian Progrip Trial |
| Study First Received: | January 8, 2009 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00820131 |
| Health Authority: | Austria: Ethikkommission |
|
Pathological Conditions, Anatomical Signs and Symptoms Hernia Hernia, Abdominal |
Neurologic Manifestations Pain Hernia, Inguinal |
|
Nervous System Diseases |
