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Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP

NCT06245577 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Intestinal Obstruction
  • Pelvic Organ Prolapse
  • Rectal Prolapse

Interventions

DEVICE

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

Sponsors & Collaborators

  • University of Cologne

    collaborator OTHER

  • Evangelisches Klinikum Köln Weyertal gGmbH

    lead OTHER

Principal Investigators

  • Privatdozentin c Rudroff · Evagelisches Klinikum Koeln Weyerta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2024-10-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245577 on ClinicalTrials.gov