Bladder Cancer Clinical Trial
— COMPETENCEOfficial title:
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | April 1, 2027 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. 2. Planned urinary diversion with an ileal conduit 3. Age = 65 years. 4. Patients considered frail by G8 screening tool (total score =14). Exclusion Criteria: 1. Patients who refuse or are not able to provide informed consent. 2. Patients who do not speak or understand Danish. 3. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | Aalborg University Hospital, Odense University Hospital, University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days Alive and out of Hospital (DAOH) | Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications. | Within 90 days after cystectomy | |
Secondary | Days Alive and out of Hospital (DAOH) | Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery. | Within 30 days after cystectomy | |
Secondary | Complications | Number and severity (Clavien-Dindo grad I-V) | Within 30 and 90 days after cystectomy | |
Secondary | Length of stay | Number of days hospitalized during the index hospitalization | Within 90 days after surgery | |
Secondary | Hospital readmissions | Number of days admitted to hospital | Within 30 and 90 days after cystectomy | |
Secondary | Patient Quality of Life | Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L) | Within 30 and 90 days postoperatively | |
Secondary | Patient Quality of Life | Quality of Life evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)). | Within 30 and 90 days postoperatively | |
Secondary | Mortality | Number | Within 30 and 90 days after cystectomy | |
Secondary | Chair stand test (CST) | Physical function measured by 30-s CST | 3 weeks postoperatively |
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