Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- PAC-SYM
研究概览
简要总结
Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.
Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.
This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Planned laparoscopic or robotic-assisted sacral colpopexy
排除标准
- •History of ulcerative colitis or Crohn's disease
- •Prior large or small bowel resection
- •Known diagnosis of gastroparesis
- •Prior pelvic radiation
- •History of abdominal or pelvic malignancy
- •Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
- •Pregnancy
- •Known allergic reactions to components of the study products
- •Known renal insufficiency
- •Non-English speaking as the primary study questionnaires are all currently in English only
研究组 & 干预措施
Bowel Preparation
Women randomized to the bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one. They will also be placed on a clear liquid diet on preoperative day number one.
干预措施: Bowel preparation (Other)
No bowel preparation
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
干预措施: No bowel preparation (Other)
结局指标
主要结局
PAC-SYM
时间窗: 1 year
Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool.
次要结局
- Perioperative complications(1 year)
- Surgeon perception of bowel preparation(1 year)
- Return of normal bowel function(1 year)
研究者
Halina M Zyczynski, MD
MD
University of Pittsburgh