Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
研究概览
简要总结
The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.
详细描述
Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •outpatients referred for colonoscopy
排除标准
- •benign prostatic hyperplasia or urinary obstruction
- •previous intestinal resection,
- •ongoing therapy with tricyclic antidepressants
- •chronic renal failure
- •history of IBD
- •participation other studies
- •unsedated colonoscopy
研究组 & 干预措施
HBB- Hioscine Butyl Bromide
干预措施: Hyoscine Butyl Bromide 20mg/2 ml i.v. (Drug)
Placebo arm
干预措施: Saline 2 ml i.v. (Drug)
结局指标
主要结局
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
时间窗: 5 months
次要结局
- Tolerability of HBB(this outcome will be evaluated at the end of colonoscopy)
研究者
Emanuele Rondonotti
Principal investigator
Valduce Hospital
