Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.
Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.
The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- 未提供
排除标准
- •Patient refusal
- •A suspected or diagnosed bowel obstruction
- •A toxic megacolon
- •Decompensated heart failure
- •Severe acute renal failure
- •Severe electrolyte imbalance
- •Previous bowel preparation in the last 7 days
- •Pregnancy
- •Time of randomization before 9h00 or after 22h00
研究组 & 干预措施
PEG electrolytes 2L/2L split dose
干预措施: PEG/electrolytes 2L/2L split dose (Drug)
Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
干预措施: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose (Drug)
结局指标
主要结局
Efficacy
时间窗: following colonoscopy
Which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
次要结局
- Tolerability(Before colonoscopy)
- Clinical quality standards(After colonoscopy)
- Cecal/ileal intubation rate(Following colonoscopy)
- Polyp detection rate(Following colonosopy)
研究者
Alan Barkun
Gastroenterologist
McGill University Health Centre/Research Institute of the McGill University Health Centre