Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rate of return of bowel function
研究概览
简要总结
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.
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 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.
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
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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 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.
研究组 & 干预措施
Pedometer Group
This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000
干预措施: Use of a pedometer following surgery (Behavioral)
Control group
This is the control group. Following radical cystectomy 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
Rate of return of bowel function
时间窗: 5-15 days
First passage of flatus/stool
Rate of post-operative ileus
时间窗: 7-21 days
Standard definition
次要结局
- Post-operative narcotic use(7-21 days)
- Post-operative pain scores(1-21 days)
- Hospital length of stay(3-14 days)
- Length of time under general anesthesia(180-420 minutes)