Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

NCT05679557 | Recruiting DMC

• 1 other identifier: 1-10-72-182-22
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Frailty; Comprehensive Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• Days Alive and out of Hospital (DAOH)

  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.

  Within 90 days after cystectomy

Secondary Outcomes (8)

• Days Alive and out of Hospital (DAOH)

  Within 30 days after cystectomy

• Complications

  Within 30 and 90 days after cystectomy

• Length of stay

  Within 90 days after surgery

• Hospital readmissions

  Within 30 and 90 days after cystectomy

• Patient Quality of Life

  Within 30 and 90 days postoperatively

Study Arms (2)

Conventional

NO INTERVENTION

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

Geriatric

EXPERIMENTAL

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

Other: Perioperative geriatric assessment and intervention

Interventions

Perioperative geriatric assessment and intervention OTHER

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.

Geriatric

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
• Planned urinary diversion with an ileal conduit
• Age ≥ 65 years.
• Patients considered frail by G8 screening tool (total score ≤14).

You may not qualify if:

• Patients who refuse or are not able to provide informed consent.
• Patients who do not speak or understand Danish.
• Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Frailty

Interventions

Methods

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jørgen S Bjerggaard Jensen, Prof., DMSc

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jørgen Bjerggaard Jensen, Prof., DMSc

CONTACT

+45 30915525; katans@rm.dk

Katharina S Prior, MD, PhD stud

CONTACT

+45 60126921; katans@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc

Model Details: A prospective, multicenter, randomized clinical trial

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 11, 2023
• Study Start: February 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)