The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Time to return of normal bowel function.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of chewing gum on reducing post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric patients undergoing surgical correction of scoliosis. This study would provide minimal risk to its study population, and has the opportunity to provide a benefit to patients undergoing scoliosis surgery. If shown to be effective, this could lead to changes and improvement of the post-operative course for pediatric scoliosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise meets criteria for surgical correction of scoliosis
- •Mental capacity to understand the purpose of the study
- •Idiopathic scoliosis or neuromuscular scoliosis with mild cerebral involvement
- •Posterior surgery approach only
排除标准
- •Unable to safely chew gum due to oropharyngeal issues or airway issues
- •History of GI surgery (G-tube, fundoplication, ostomy etc...)
- •Anterior approach
结局指标
主要结局
Time to return of normal bowel function.
时间窗: 72-96 hours
Patients are interviewed daily as inpatient and then several days after surgery to determine the time (reported in hours post-operative) first flatus and first bowel movement was experienced.
次要结局
未报告次要终点
研究者
Joseph G. Khoury, MD
Assistant Professor - Pediatric Orthopaedic Surgery
University of Alabama at Birmingham