Status:
SUSPENDED
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
Lead Sponsor:
University of Wuerzburg
Conditions:
Incisional Hernia
Eligibility:
All Genders
18+ years
Brief Summary
From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide. The purpose of the study is to evaluate retrospec...
Detailed Description
From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and co...
Eligibility Criteria
Inclusion
- Age \> 18
- Incisional hernia
Exclusion
- Younger than 18 years
- Peritonitis
- Intestinal fistula
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01520168
Start Date
October 1 2003
End Date
March 1 2012
Last Update
March 13 2012
Active Locations (1)
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1
Department of General, Visceral, Vascular and Pediatric Surgery
Würzburg, Bavaria, Germany, 97080