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Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP
Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
Summary
The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.
Official title: Prospective Randomized Pilot Study on the Use of Biological Mesh Versus Synthetic Mesh in Interdisciplinary Resection Rectopexy With Sacro Colpopexy
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-01-30
Completion Date
2025-12-31
Last Updated
2024-11-18
Healthy Volunteers
No
Interventions
interdisciplinary mesh sacro colpopexy with resection rectopexy
surgical reconstruction of the middel pelvic compartment with the above mentioned meshes combined with a resection rectopexy in a simultaneous interdisciplinary procedure
Locations (1)
Evangelisches Klinikum Koeln Weyertal
Cologne, North Rhine-Westphalia, Germany