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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedometer group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a pedometer following surgery | Behavioral | Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post operative narcotic use | Morphine equivalents used following radical prostatectomy. | 7-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of return of bowel function | First passage of flatus and first bowel movement following surgery | 7-14 days |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Basil Ferenczi, MD | Contact | 206-223-6600 | basil.ferenczi@virginiamason.org |
| Name | Affiliation | Role |
|---|---|---|
| John Corman, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Recruiting | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Behavioral | Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |