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.
Full Title of Study: “Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: March 2021
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.
- Behavioral: Use of a pedometer following surgery
- Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
- Behavioral: Standard of care
- Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
Arms, Groups and Cohorts
- Experimental: 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
- Active Comparator: 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.
Clinical Trial Outcome Measures
- Rate of post-operative ileus
- Time Frame: 7-21 days
- Standard definition
- Rate of return of bowel function
- Time Frame: 5-15 days
- First passage of flatus/stool
- Post-operative narcotic use
- Time Frame: 7-21 days
- Morphine equivalents used following radical cystectomy.
- Hospital length of stay
- Time Frame: 3-14 days
- Time begins day of surgery to day of discharge. Time in days
- Post-operative pain scores
- Time Frame: 1-21 days
- Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
- Length of time under general anesthesia
- Time Frame: 180-420 minutes
- Time from induction to emergence of anesthesia in minutes
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Benaroya Research Institute
- Virginia Mason Hospital/Medical Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- John Corman, MD, Principal Investigator, Virginia Mason Medical Center
- Overall Contact(s)
- Basil Ferenczi, MD, 206-223-6600, email@example.com
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