K59.01
Conditions
Interventions
Group 1: Experimental intervention: Biomesh for L-SCP in the combined intervention
Group 2: Control intervention: standard synthetic mesh for L-SCP in the combined intervention
Sponsors
Ev. Klinikum Köln Weyertal
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: Clinically defined exclusion criteria are missing, allergy to the components of the mesh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbidity and mortality according to the Clavien-Dindo Classification (CDC) up to 12 months after surgery (maximum value) | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in medical condition as measured by clinical scores for bowel function (Altomare, rectal toxicity, Wexner incontinence) Improvement of the pelvic organ prolapse (Pelvic Organ Prolapse Quantification (POP-Q)) | — |
Countries
Germany
Contacts
Public ContactClaudia Rudroff
Universitätklinik Köln , Klinik für Urologie
Outcome results
None listed