Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Bowel Function Recovery
研究概览
简要总结
The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.
详细描述
The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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;
- •Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;
排除标准
- •Prior intestinal surgery
- •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
- •Pregnant women
- •Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.
- •Patients requiring postoperative ventilation, pressor requirement or ICU stay
- •Patients with prior cardiovascular disorders
研究组 & 干预措施
Nicotine gum
100 subjects who will actually get the intervention medication
干预措施: Nicotine gum (Drug)
regular chewing gum
100 subjects who will be part of a control group
干预措施: Regular chewing gum (Other)
结局指标
主要结局
Bowel Function Recovery
时间窗: 7 days
Time to first bowel movement or flatus
次要结局
- Post-operative Vomiting(30 days)
- Use of NG Tubes(30 days)
- Hospital Stay(30 days)
研究者
Eric Weiss
DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,
The Cleveland Clinic