Ambulation Difficulty, Prostate Cancer
Conditions
Keywords
radical prostatectomy, pedometer, return of bowel function, post-operative narcotic use
Brief summary
This is a study to evaluate whether use of a pedometer following radical prostatectomy 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 prostatectomy on 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 14. 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 initial post-operative visit.
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
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.
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 prostatectomy * 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 |
|---|---|---|
| Post operative narcotic use | 7-14 days | Morphine equivalents used following radical prostatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of return of bowel function | 7-14 days | First passage of flatus and first bowel movement following surgery |
Countries
United States
Contacts
Primary ContactBasil Ferenczi, MD
Outcome results
None listed