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NCT Number: NCT05679557

Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Days Alive and out of Hospital (DAOH)

    Time frame: 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 outcomes

  1. Days Alive and out of Hospital (DAOH)

    Time frame: Within 30 days after cystectomy

    Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.

  2. Complications

    Time frame: Within 30 and 90 days after cystectomy

    Number and severity (Clavien-Dindo grad I-V)

  3. Length of stay

    Time frame: Within 90 days after surgery

    Number of days hospitalized during the index hospitalization

  4. Hospital readmissions

    Time frame: Within 30 and 90 days after cystectomy

    Number of days admitted to hospital

  5. Patient Quality of Life

    Time frame: Within 30 and 90 days postoperatively

    Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)

  6. Patient Quality of Life

    Time frame: 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)).

  7. Mortality

    Time frame: Within 30 and 90 days after cystectomy

    Number

  8. Chair stand test (CST)

    Time frame: 3 weeks postoperatively

    Physical function measured by 30-s CST

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Odense University Hospital
  • University of Aarhus

Registry information

Acronym: COMPETENCE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 11, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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