Health TrialsbyHealthPanel

Patient-Centered Surgical Prehabilitation

ConditionsBladder CancerCystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBrigham and Women's Hospital

About this trial

The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach.

Patients between the ages 18 and 85 years

American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4

Ileal conduit or ileal neobladder urinary diversion

Disqualifiers

Scheduled for a partial cystectomy

Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy

More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery

The presence of metastatic cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise Training

    Other intervention

    Virtually supervised exercise training for four weeks prior to cystectomy

  • Nutritional Intervention

    Dietary supplement

    Patients scheduled to undergo cystectomy will receive liquid Ensure supplemental shakes for 2 weeks prior to surgery and liquid Ensure supplemental shakes for 1 week postoperatively

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Standard treatment PlanOther 2 interventions

Trial outcomes

Primary outcomes

1

Total days hospitalized within 30-days of surgery

This is the total number of days within 30 days after bladder removal surgery, that a patient is hospitalized.

Time frame
60 months
2

Length of stay

This is the total length of stay in days after bladder removal surgery

Time frame
60 months
3

Number and type of minor and major complications

This is the number and types of major and minor complications which occur post bladder removal surgery

Time frame
60 months
4

Discharge disposition

This is the disposition of the patient at discharge or when the patient is released from the hospital.

Time frame
60 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Brigham and Women's Hospital

Lead sponsor

Abbott Nutrition

Collaborator

Source ClinicalTrials.gov
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