Clinical trial NCT05679557: Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Official title: Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: Frailty
Comprehensive Geriatric Assessment
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aalborg University Hospital
name: Odense University Hospital
First posted: 2023-01-11
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multicenter, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Days Alive and out of Hospital (DAOH)
timeFrame: Within 90 days after cystectomy
Secondary outcomes:
measure: Days Alive and out of Hospital (DAOH)
timeFrame: Within 30 days after cystectomy
measure: Complications
timeFrame: Within 30 and 90 days after cystectomy
measure: Length of stay
timeFrame: Within 90 days after surgery
measure: Hospital readmissions
timeFrame: Within 30 and 90 days after cystectomy
measure: Patient Quality of Life
timeFrame: Within 30 and 90 days postoperatively
measure: Patient Quality of Life
timeFrame: Within 30 and 90 days postoperatively
measure: Mortality
timeFrame: Within 30 and 90 days after cystectomy
measure: Chair stand test (CST)
timeFrame: 3 weeks postoperatively
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Jørgen S Bjerggaard Jensen, Prof., DMSc
role: PRINCIPAL_INVESTIGATOR
References: