Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Laparoscopic Robot Assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post operative narcotic use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.
排除标准
- •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.
研究组 & 干预措施
Pedometer group
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.
干预措施: Use of a pedometer following surgery (Behavioral)
Control group
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.
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Post operative narcotic use
时间窗: 7-14 days
Morphine equivalents used following radical prostatectomy.
次要结局
- Rate of return of bowel function(7-14 days)