A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Time (in hours) to tolerating a low residue diet
研究概览
简要总结
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal 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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- •American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- •Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
排除标准
- •Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- •American Society of Anesthesiologists (ASA) Class IV or V;
- •History of abdominal carcinomatosis
- •History of radiation enteritis
- •Children < 18 or adults > 85 years of age
研究组 & 干预措施
Sugared Chewing Gum
Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time
干预措施: Sugared Chewing Gum (Juicy Fruit) (Dietary Supplement)
No Gum
No gum given, routine postoperative care provided
结局指标
主要结局
Time (in hours) to tolerating a low residue diet
时间窗: 30 day postoperative period
Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours
次要结局
- Time (in hours) to passage of flatus(30 day postoperative period)
- Daily Appetite Assessment(Postoperative day 1 - 7)
- Daily pain assessment(Postoperative day 1 - 7)
- Major or Minor Medical and Surgical Complications(30 day postoperative period)
- Length of postoperative hospitalization in days(Duration of postoperative hospitalization (expected average of 5 days))
- Time (hours) to first bowel movement(30 day postoperative period)
- Daily nausea assessment(Postoperative day 1 - 7)
研究者
Phillip Fleshner MD
Pricipal investigator
Cedars-Sinai Medical Center