Use of Pedometer Following Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Laparoscopic Robot Assisted Radical Prostatectomy

Conditions
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Prostate Cancer, Ambulation Difficulty

Intervention / Treatment
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* Behavioral: Use of a pedometer following surgery
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer group<br>This group will be given a pedometer following radical prostatectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 2,000/day. POD 3-6: 3,000/day. POD 7-9: 4,000/day. POD 10-14: 5,000/day. | Behavioral: Use of a pedometer following surgery<br>* Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.<br>|
| Active Comparator: Control group<br>This is the control group. Following radical prostatectomy, subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery. | Behavioral: Standard of care<br>* Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative narcotic use | Morphine equivalents used following radical prostatectomy. | 7-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of return of bowel function | First passage of flatus and first bowel movement following surgery | 7-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy, pedometer, return of bowel function, post-operative narcotic use