Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Adenoma detection rate(ADR)
研究概览
简要总结
This is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. The secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with age > 18 years who attended for colorectal cancer screening colonoscopy.
排除标准
- •Participants who had been colectomy
- •Participants who diagnosed of inflammatory bowel disease or polyposis syndrome.
- •Participants who had been took anti-spasmosic drugs prior to colonoscopy within 24 hours (Anticholibergic/Antimuscarinic : Hyoscine(Buscopan®), Dicyclomine(Berclomine®) or Smooth muscle relaxant : Mebeverine(Duspatin®,Colofac®), Pinaverium bromide(Dicetel®), Alverine(Meteospasmyl®), Peppermint oil(Colpermin®))
- •Participants with Prothrombin time > 3 second ULN, INR > 1.5 or Platelet < 50,
- •Pregnancy or breast feeding
- •Participants who cannot consent.
- •Participants who had history of peppermint oil allergy.
研究组 & 干预措施
Peppermint oil
1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)
干预措施: Intraluminal peppermint oil (Drug)
Placebo
Placebo solution 50ml(Simethicone plus tween)
干预措施: Placebo (Drug)
结局指标
主要结局
Adenoma detection rate(ADR)
时间窗: During colonoscopy
Number of adenoma per total participants who were colonoscopy in both groups
次要结局
- Time of polyps resection(During colonoscopy)
- Intravenous anti-spasmodic agents(During colonoscopy)
- Adenoma per posititive participants(APP)(During colonoscopy)
- Colonic peristalsis grading(During colonoscopy)
- Adeverse events(24 hours after colonoscopy)
研究者
Uayporn Kaosombatwattana
Department of Medicine, Siriraj Hospital, Mahidol university
Mahidol University