Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Time to first postoperative bowel movement
研究概览
简要总结
A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate postoperative period following pelvic reconstructive surgery in women taking routine docusate sodium.
B. Objectives
- Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between MiraLAX versus placebo in women receiving routine docusate sodium after pelvic reconstructive surgery.
Specific Aim 2: To compare patient reported outcomes of BM quality and associated gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool scale and the validated Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive surgery.
Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive surgery. 2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent constipation following pelvic reconstructive surgery by decreasing time to first BM, decreasing GI symptoms associated with constipation, and increasing measures of GI-related quality of life, while minimizing the bothersome side effects associated with stimulant laxatives.
详细描述
This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo in women undergoing pelvic reconstructive surgery receiving routine docusate sodium. Subjects will be screened for eligibility during their preoperative visits and once enrolled, they will be randomized to receive MiraLAX or placebo starting on postoperative day (POD) 1 and continuing through POD 5. Subjects will be instructed to stop taking this medication if they experience any diarrhea. Subjects in both arms will be instructed to take milk of magnesia as a rescue laxative if they do not experience a BM by the morning of POD 6. All subjects will be provided a 30 day supply of docusate sodium and be instructed to begin this medication on POD 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking female patients
- •> 18 years of age
- •Not pregnant (patients of childbearing potential will have a serum pregnancy test done pre-operatively as part of their surgical planning)
- •Undergoing surgery for pelvic organ prolapse or stress urinary incontinence
- •Recruited from the Duke University Division of Urogynecology
排除标准
- •Allergy/hypersensitivity to study medications
- •Cardiac or renal disease
- •Takes chronic daily laxatives
- •Excluded if unable to complete at least 5 days of a 7 day baseline bowel diary
- •Excluded if mesh resection or Interstim procedure
- •Excluded if concurrent surgery includes anal sphincteroplasty or rectovaginal fistula repair
研究组 & 干预措施
Placebo
Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
干预措施: Placebo (Drug)
Placebo
Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
干预措施: Rescue Laxative (Drug)
MiraLax
MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
干预措施: MiraLax (Drug)
MiraLax
MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
干预措施: Rescue Laxative (Drug)
结局指标
主要结局
Time to first postoperative bowel movement
时间窗: First postoperative week
The primary outcome is time to first postoperative bowel movement (in hours, converted to days) based upon postoperative bowel diary. Time will be calculated based upon date and time of first postoperative bowel movement from start time of surgery.
次要结局
- Other postoperative medication use(First postoperative week)
- Symptoms of Over-Effectiveness(First Postoperative Week)
- Evaluation of symptoms and quality of life related to constipation(First postoperative week)
- Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively(5-7 weeks postoperatively)