Active — Not RecruitingNot Applicable

Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP

Germany30 participantsStarted 2024-01-30

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * clinical diagnosis of obstructed defection syndrome * clinical diagnosis of pelvic organ prolapse pelvic organ prolapse * must be suitable for surgery Exclusion Criteria: * allergy to the components of the mesh * pregnancy

What they're measuring

safety of the experimental internvention as measured by surgical outcome

Timeframe: 12 months

Trial details

NCT IDNCT06245577

SponsorEvangelisches Klinikum Köln Weyertal gGmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Intestinal Obstruction trials