Efficacy and Tolerability of Low-volume Polyethylene Glycol (2 L) vs. Single- (4 L) vs. Split-dose (2L + 2L) of Polyethylene Glycol Bowel Preparation for Colonoscopy: a Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- satisfactory bowel preparation
研究概览
简要总结
the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.
详细描述
In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am).
The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded.
Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In-hospital patients with an indication for colonoscopy
排除标准
- •patients under 18 years of age
- •the presence of a severe illness (cardiac, renal, or metabolic)
- •major psychiatric illness
- •known allergies to PEG-3350
- •refusal to consent to the study
研究组 & 干预措施
PEG-3350 group 3
group 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am).
干预措施: PEG-3350 group 3 (Drug)
PEG-3350 group 1
group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h)
干预措施: PEG-3350 group 1 (Drug)
PEG-3350 group 2
group 2: split-dose (PEG-3350 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
干预措施: PEG-3350 group 2 (Drug)
结局指标
主要结局
satisfactory bowel preparation
时间窗: at the moment of colonoscopy
The aim of this study was to test the quality of bowel preparation and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.
次要结局
- tolerability with bowel preparation(just before to start the colonoscopy and before any sedative be administered)
研究者
Felix Tellez
Ph.D.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran