Use of Pedometer Following Radical Cystectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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.
|
| 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. |
Behavioral: Standard of care
Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
|
Outcome Measures
Primary Outcome Measures
- Rate of post-operative ileus [7-21 days]
Standard definition
- Rate of return of bowel function [5-15 days]
First passage of flatus/stool
Secondary Outcome Measures
- Post-operative narcotic use [7-21 days]
Morphine equivalents used following radical cystectomy.
- Hospital length of stay [3-14 days]
Time begins day of surgery to day of discharge. Time in days
- 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)
- Length of time under general anesthesia [180-420 minutes]
Time from induction to emergence of anesthesia in minutes
Eligibility Criteria
Criteria
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:
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Long-term opioid use, defined by CDC as use of opioids on most days for >3 months
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History of inflammatory bowel disease
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Prior abdominopelvic radiation
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Travel to Europe during study period
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Concurrent surgery during radical cystectomy
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Inability to ambulate
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Gastroparesis or other baseline bowel dysmotility issues
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Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Benaroya Research Institute
- Virginia Mason Hospital/Medical Center
Investigators
- Principal Investigator: John Corman, MD, Virginia Mason Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB 20-020