Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Not Applicable

Recruiting

• Conditions: Bladder Cancer
• Interventions: Other: Perioperative geriatric assessment and intervention

• Registration Number: NCT05679557
• Lead Sponsor: Aarhus University Hospital

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 Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-11
• Study Start: 2023-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric	Perioperative geriatric assessment and intervention	Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy.

Primary Outcome Measures

Name	Time	Method
Days Alive and out of Hospital (DAOH)	Within 90 days after cystectomy	Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications.

Secondary Outcome Measures

Name	Time	Method
Length of stay	Within 90 days after surgery	Number of days hospitalized during the index hospitalization
Complications	Within 30 and 90 days after cystectomy	Number and severity (Clavien-Dindo grad I-V)
Patient Quality of Life	Within 30 and 90 days postoperatively	Quality of Life evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)).
Mortality	Within 30 and 90 days after cystectomy	Number
Chair stand test (CST)	3 weeks postoperatively	Physical function measured by 30-s CST
Days Alive and out of Hospital (DAOH)	Within 30 days after cystectomy	Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.
Hospital readmissions	Within 30 and 90 days after cystectomy	Number of days admitted to hospital

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark