Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | No Intervention | Perioperative "care as usual" according to exciting principles and guidelines | |
| Geriatric | Experimental | Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative geriatric assessment and intervention | Other | The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment (CGA) and tailored interventions, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Complications | Number and severity (Clavien-Dindo grad I-V) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jørgen Bjerggaard Jensen, Prof., DMSc | Contact | +45 30915525 | katans@rm.dk | |
| Katharina S Prior, MD, PhD stud | Contact | +45 60126921 | katans@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jørgen S Bjerggaard Jensen, Prof., DMSc | Aarhus University Hospital and Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
A prospective, multicenter, randomized clinical trial
Not provided
Not provided
Not provided
Not provided
|
| Within 30 and 90 days after cystectomy |
| Length of stay | Number of days hospitalized during the index hospitalization | Within 90 days after surgery |
| Hospital readmissions | Number of days admitted to hospital | Within 30 and 90 days after cystectomy |
| Patient Quality of Life | Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L) | Within 30 and 90 days postoperatively |
| 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 |
| Mortality | Number | Within 30 and 90 days after cystectomy |
| Chair stand test (CST) | Physical function measured by 30-s CST | 3 weeks postoperatively |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |