Use of Pedometer Following Radical Cystectomy
- Conditions
- Bladder CancerIleusNarcotic 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
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.
- 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
Name Time Method Rate of return of bowel function 5-15 days First passage of flatus/stool
Rate of post-operative ileus 7-21 days Standard definition
- Secondary Outcome Measures
Name Time Method Post-operative narcotic use 7-21 days Morphine equivalents used following radical cystectomy.
Post-operative pain scores 1-21 days Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Hospital length of stay 3-14 days Time begins day of surgery to day of discharge. Time in days
Length of time under general anesthesia 180-420 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 StatesBasil A Ferenczi, MDContact206-223-6772basil.ferenczi@virginiamason.org