NCT06253689已完成不适用
Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Straining with first postoperative bowel movement
研究概览
简要总结
This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery by one of the sub investigators including a posterior compartment repair
排除标准
- •Anyone currently using a defecation posture modification device
- •Unwillingness or unable to participate in the study
- •Presence of ileostomy/colostomy
- •Wheelchair bound
- •Device may pose fall or safety hazard risk to patient
- •Patients weighing over 250 lbs, as per device manufacturer guidelines
- •Inability to understand English
- •Pregnant women
研究组 & 干预措施
Defecation Posture Modification Device
Experimental
干预措施: Defecation Posture Modification Device (Device)
Control
No Intervention
结局指标
主要结局
Straining with first postoperative bowel movement
时间窗: 1 week
patients will keep 7 day log of each postoperative bowel movement within the first week of surgery, they will assess with an 11 point numeric rating scale their level of strain with bowel movement, the scale starts at 0 indicating no straining and 10 indicating maximal straining/effort. I high score of 10 means a worse outcome. The scale title is "straining with bowel movement".
次要结局
- Time to first bowel movement(1 week)
- pain with postoperative bowel movements(1 week)
- postoperative stool consistency(1 week)
- Postoperative use of laxatives and pain medication(1 week)
- Satisfaction with device and ease of use(1 month)
研究者
研究点 (3)
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