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Trial Title:
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
NCT ID:
NCT05679557
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Frailty
Comprehensive Geriatric Assessment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A prospective, multicenter, randomized clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Perioperative geriatric assessment and intervention
Description:
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.
Arm group label:
Geriatric
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.
Criteria for 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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Lasse Bro, MD
Start date:
February 1, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Aalborg University Hospital
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679557
