Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh
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|ClinicalTrials.gov Identifier: NCT00323674|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Active, not recruiting
First Posted : May 9, 2006
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Device: Polysoft Mesh Device: Light Weight Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
|Active Comparator: Light Weight Mesh||
Device: Light Weight Mesh
Light Weight Mesh is used.
|Active Comparator: Polysoft Mesh||
Device: Polysoft Mesh
Polysoft Mesh is used.
- Percentage of relapse [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]
- Postoperative pain assessment [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]
- Duration to full recovery (able to do all activities) [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]
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): NCT00323674
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Frederik Berrevoet, MD||University Hospital, Ghent|