Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perioperative geriatric assessment and intervention.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other Perioperative geriatric assessment and intervention
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.
Primary outcome measures
- Days Alive and out of Hospital (DAOH) [Time frame: Within 90 days after cystectomy]
Secondary outcome measures (8)
- Days Alive and out of Hospital (DAOH) [Time frame: Within 30 days after cystectomy]
- Complications [Time frame: Within 30 and 90 days after cystectomy]
- Length of stay [Time frame: Within 90 days after surgery]
- Hospital readmissions [Time frame: Within 30 and 90 days after cystectomy]
- Patient Quality of Life [Time frame: Within 30 and 90 days postoperatively]
- Patient Quality of Life [Time frame: Within 30 and 90 days postoperatively]
- Mortality [Time frame: Within 30 and 90 days after cystectomy]
- Chair stand test (CST) [Time frame: 3 weeks postoperatively]
Eligibility criteria
Inclusion criteria
- Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
- Planned urinary diversion with an ileal conduit
- Age ≥ 65 years.
- Patients considered frail by G8 screening tool (total score ≤14).
Exclusion criteria
- Patients who refuse or are not able to provide informed consent.
- Patients who do not speak or understand Danish.
- Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Identifiers
NCT: NCT05679557 · 1-10-72-182-22