Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- First Bowel Movement
研究概览
简要总结
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
详细描述
In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.
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 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
排除标准
- •Age under 18 or over 90
- •Planned laparotomy
- •Planned posterior colporrhaphy
- •Regular pre-operative use of stool softeners/laxatives
- •Presence of colostomy
- •Inability to give informed consent
- •Inability to take medication by mouth
- •Chronic kidney disease (Cr > 1.2)
- •Esophageal strictures
- •Persistent nausea and vomiting
- •Bowel obstruction
- •Inflammatory bowel disease
研究组 & 干预措施
Experimental
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
干预措施: Polyethylene Glycol Powder (Drug)
结局指标
主要结局
First Bowel Movement
时间窗: 7 days post-operatively
Time to first post-operative bowel movement will be evaluated.
次要结局
- Post Operative Pain With First Bowel Movement as Measured by the VAS Scale.(7 days post-operatively)
- Post Operative Pain at Day 1 as Measured by the VAS Scale(1 day post-operatively)
- Median Postoperative Pain(Averaged over 7 days post-operatively)