Effect of Chewing Gum Combined With Manual Enhanced Instructions by WeChat on the Bowel Preparation Quality for Colonoscopy in Patients With Constipation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Bowel preparation quality
研究概览
简要总结
Patients with constipation are more likely to have poor bowel preparation quality due to slow gut motility and poor emptying ability. Gum chewing, as a proxy of sham feeding, is a very simple way used to accelerate gut motility. And a previous study found that enhanced instructions by WeChat could improve bowel preparation quality. Thus, investigators conducted a single-center randomized controlled trial to explore the effect of chewing gum combined with manual enhanced instructions by WeChat on the bowel preparation quality for colonoscopy in patients with constipation.
详细描述
In this randomized controlled trial, consecutive outpatients with constipation for colonoscopy are screened and then randomized into two groups. All enrolled patients will receive 3 liter polyethylene glycol (PEG) for bowel preparation. Patients in the chewing gum and WeChat group (n = 75) are further advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter PEG; additionally, they will receive enhanced instructions via WeChat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation. Patients in the control group (n = 75) are guided by regular instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Patients undergoing colonoscopy at the Department of Gastroenterology of the General Hospital of Northern Theater Command.
- •Patients aged ≥18 years, no gender limitation.
- •Patients who sign informed consent.
- •Patients who are diagnosed with constipation.
排除标准
- •Patients who are pregnant or breastfeeding.
- •Patients who are allergic to polyethylene glycol.
- •Patients who are suspected with intestinal obstruction, stenosis or perforation.
- •Patients with mental illness.
- •Patients with serious heart, brain, liver, and kidney diseases.
- •Patients who use WeChat unconditionally by themselves or their family members.
- •Patients who are allergic to chewing gum related ingredients.
- •Patients with the history of colorectal surgery.
研究组 & 干预措施
Chewing gum combined with WeChat enhanced instructions group
Patients in the chewing gum and WeChat group are advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter PEG. They also receive enhanced instructions via WeChat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation.
干预措施: Chewing gum combined with WeChat enhanced instructions (Other)
Control group
Patients in the control group are guided by regular instructions.
结局指标
主要结局
Bowel preparation quality
时间窗: During colonoscopy procedure, an average of 30 minutes
Bowel preparation quality is evaluated by the Boston bowel preparation scale (BBPS) score: Segment score 0: unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Segment score 1: portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. Segment score 2: minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. Segment score 3: entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid.
次要结局
- The number of polyp and/or adenoma(During colonoscopy procedure, an average of 30 minutes)
- Cecal intubation time(During colonoscopy procedure, an average of 30 minutes)
- Polyp and/or adenoma detection rate(During colonoscopy procedure, an average of 30 minutes)
- Adverse events(During colonoscopy procedure, an average of 30 minutes)
研究者
Xingshun Qi
Doctor
General Hospital of Shenyang Military Region