Biological mesh versus synthetic mesh in interdisciplinary RRP with SCP
Phase 2
Recruiting
- Conditions
- K59.00
- Registration Number
- DRKS00033079
- Lead Sponsor
- Ev. Klinikum Köln Weyertal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 28
Inclusion Criteria
Female patient with ODS and POP scheduled for surgery, clinical POP Q = 1°, age > 18 years < 80 years, ASA 1 - 3, negative pregnancy test, no planned pregnancy during the study
Exclusion Criteria
Clinically defined exclusion criteria are missing, allergy to the components of the mesh
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morbidity and mortality according to the Clavien-Dindo Classification (CDC) up to 12 months after surgery (maximum value)
- Secondary Outcome Measures
Name Time Method Improvement in medical condition as measured by clinical scores for bowel function (Altomare, rectal toxicity, Wexner incontinence) <br>Improvement of the pelvic organ prolapse (Pelvic Organ Prolapse Quantification (POP-Q))