Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Benaroya Research Institute
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Rate of return of bowel function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pedometer Group
This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000
Intervention: Use of a pedometer following surgery (Behavioral)
Control group
This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.
Intervention: Standard of care (Behavioral)
Outcomes
Primary Outcomes
Rate of return of bowel function
Time Frame: 5-15 days
First passage of flatus/stool
Rate of post-operative ileus
Time Frame: 7-21 days
Standard definition
Secondary Outcomes
- Post-operative narcotic use(7-21 days)
- Post-operative pain scores(1-21 days)
- Hospital length of stay(3-14 days)
- Length of time under general anesthesia(180-420 minutes)