Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy (COMPETENCE)

Aarhus University Hospital

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: Perioperative geriatric assessment and intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05679557

1-10-72-182-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Conventional

No Intervention group

Description:

Perioperative "care as usual" according to exciting principles and guidelines

Geriatric

Experimental group

Description:

Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy.

Treatment:

Other: Perioperative geriatric assessment and intervention