Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Bowel function (as assessed by questionnaire)
研究概览
简要总结
It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.
详细描述
Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.
The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).
The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
排除标准
- •Emergency colorectal surgery, unable to consent
结局指标
主要结局
Bowel function (as assessed by questionnaire)
时间窗: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Time to passage of flatus
次要结局
- Diet (as assessed by questionnaire)(Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation))
- Length of stay(Days (till successful discharge from secondary care to home or respite care measured up to first 31 days))
- Morbidity(Days (recorded up to 30 days and defined by Clavien-Dindo scale))
- Post op nausea and vomiting score (as recorded by visual analogue scale)(Recorded daily for first 5 days)
研究者
Dale Vimalachandran
Consultant Colorectal Surgeon
Countess of Chester NHS Foundation Trust