Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale (BPPS)
研究概览
简要总结
The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.
详细描述
High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.
Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.
In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).
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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •people who receive colonoscopy
- •aged : 18-80
- •people who sign the consent
排除标准
- •those aged over 80 years
- •the disabled
- •intestinal obstruction
- •severe constipation
- •previous history of bowel resection
- •liver cirrhosis
- •heart failure or ischemic heart disease within 6 months
- •inflammatory bowel disease
- •pregnant women
- •severe renal insufficiency
- •people who refuse to sign the consent
研究组 & 干预措施
Oral sulfate solution (OSS)
oral sulfate solution (OSS)
干预措施: Oral sulfate solution (OSS) (Drug)
2-L PEG/Asc
low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)
干预措施: 2-L PEG/Asc (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale (BPPS)
时间窗: during colonoscopy
Aronchick scale
时间窗: during colonoscopy
Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.
次要结局
- Withdrawal time(during colonoscopy)
- Adenoma detection rate(during colonoscopy)
- Tolerability by a patient questionnaire using 5-point Likert scale(on arrival at the endoscopy unit before colonoscopy)
- Safety by measuring hemodynamic and biochemical data(at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite)
- Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers(during colonoscopy)
- Percentage of cecal intubation(during colonoscopy)
- Insertion time(during colonoscopy)
研究者
Bo-In Lee
MD, PhD
Seoul St. Mary's Hospital