Bladder Cancer, Ileus, Narcotic Use
Conditions
Keywords
radical cystectomy, narcotic use, post-operative ileus, return of bowel function
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.
Interventions
BEHAVIORALUse of a pedometer following surgery
Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
BEHAVIORALStandard of care
Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
Sponsors
Virginia Mason Hospital/Medical Center
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactBasil Ferenczi, MD
Outcome results
None listed