Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 1:52 AM
Study NCT ID:
NCT05679557
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2022-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Sponsor:
Aarhus University Hospital
Organization:
Study Overview
Official Title:
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPETENCE
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: