Comprehensive Outcome Measures and Perioperative Morbidity After Cystectomy
Recruiting
- Conditions
- C67Malignant neoplasm of bladder
- Registration Number
- DRKS00024929
- Lead Sponsor
- Klinik und Poliklinik für Urologie, Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Patients capable of giving consent =18 years undergoing radical cystectomy (with anterior exenteration if necessary) or cystoprostatectomy with urinary diversion.
Exclusion Criteria
Patients unable to give informed consent, pregnant women and minors <18 years of age
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Perioperative and long-term morbidity:<br>- Clavien-Dindo classification<br>- Comprehensive Complication Index®<br><br>(assessment at 30 and 90 days as well as at 12 months)<br><br>(2) Functional, patient-centered outcomes / Patient-reported Outcome Measures (PROMs):<br>- FACT-Bl-Cys<br>- EORTC QLQ-C30 / QLQ-BLM-30<br><br>(assessment preoperatively, at 30 and 90 days, at 6, 12, and 24 months)<br><br>(3) Oncological outcomes:<br>- Overall survival<br>- Cancer-specific survical<br>- Disease-free survival<br><br>(assessment at 90 days, 6, 12, and 24 months)
- Secondary Outcome Measures
Name Time Method