Health TrialsbyHealthPanel

Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAarhus University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perioperative geriatric assessment and intervention

    Other intervention

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ConventionalNo intervention 0 interventions
Group B: GeriatricExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Within 90 days after cystectomy

Secondary outcomes

1

Days Alive and out of Hospital (DAOH)

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

Time frame
Within 30 days after cystectomy
2

Complications

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

Time frame
Within 30 and 90 days after cystectomy
3

Length of stay

Number of days hospitalized during the index hospitalization

Time frame
Within 90 days after surgery
4

Hospital readmissions

Number of days admitted to hospital

Time frame
Within 30 and 90 days after cystectomy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

University of Aarhus

Collaborator

Aalborg University Hospital

Collaborator

Odense University Hospital

Collaborator

Source ClinicalTrials.gov
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