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Use of Pedometer Following Radical Cystectomy

Not Applicable
Conditions
Bladder Cancer
Ileus
Narcotic Use
Registration Number
NCT04305730
Lead Sponsor
Benaroya Research Institute
Brief Summary

This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

Detailed Description

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 21. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until post-operative day 21.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
35
Inclusion Criteria

This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study.

Exclusion Criteria
  • Long-term opioid use, defined by CDC as use of opioids on most days for >3 months
  • History of inflammatory bowel disease
  • Prior abdominopelvic radiation
  • Travel to Europe during study period
  • Concurrent surgery during radical cystectomy
  • Inability to ambulate
  • Gastroparesis or other baseline bowel dysmotility issues
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Rate of return of bowel function5-15 days

First passage of flatus/stool

Rate of post-operative ileus7-21 days

Standard definition

Secondary Outcome Measures
NameTimeMethod
Post-operative narcotic use7-21 days

Morphine equivalents used following radical cystectomy.

Post-operative pain scores1-21 days

Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

Hospital length of stay3-14 days

Time begins day of surgery to day of discharge. Time in days

Length of time under general anesthesia180-420 minutes

Time from induction to emergence of anesthesia in minutes

Trial Locations

Locations (1)

Virginia Mason Medical Center

🇺🇸

Seattle, Washington, United States

Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Basil A Ferenczi, MD
Contact
206-223-6772
basil.ferenczi@virginiamason.org

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