Effects of Preoperative Bowel Preparation Prior to Elective Bowel Resection or Ostomy Closure in the Pediatric Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- complications following surgery
研究概览
简要总结
Current management of elective bowel surgery typically involves performing a preoperative bowel preparation ("bowel prep") in many instances; however, this practice is not standardized at most institutions. Over the years, bowel preps have been used in an attempt to decrease the risk of complications associated with gastrointestinal surgery. However, there is limited adequate data to support this clinical management in the pediatric patient population. The investigator plans to perform a prospective, randomized study of our pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to assess if a bowel prep prior to surgical intervention affects their postoperative course. The aim of this study is to evaluate for differences that may alter and improve future management.
详细描述
At CMH, our current approach to preoperative management for elective intestinal surgery is not standardized amongst our Pediatric Surgical attendings. There are seven different attendings, each of whom individually dictates if a patient is to undergo a preoperative bowel prep, and if so, which bowel prep will be used. This is no different than the majority of practices across the US, including adult and pediatric patient populations. The aim of this study, therefore, is to standardize our current management and assess if the presence or absence of a preoperative bowel prep has an effect on post-operative outcomes. The goal is to evaluate the effect of the bowel preparation not the surgical procedure itself.
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
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children, ages 3 months to 17 years, who will undergo an elective bowel resection or ostomy closure at CMH
排除标准
- •Patients whose operation was performed emergently, and hence a bowel prep was not possible preoperatively;
- •If they necessitate a diverting proximal ostomy;
- •If they have any known intra-abdominal infection preoperatively;
- •If an intra-operative colonoscopy is necessary, and hence the patient must have a preoperative bowel prep.
- •No patients with an underlying malignancy or immunodeficiency or with renal, metabolic or cardiac conditions will be included.
- •No patients with known allergies to any medication used in the bowel preparation will be included.
结局指标
主要结局
complications following surgery
时间窗: 6 weeks
compications such as infection, leaks, obstruction etc
次要结局
- Length of hospital stay(10 days)
研究者
Shawn St. Peter
Associate Professor
Children's Mercy Hospital Kansas City