Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Adequacy of bowel preparation
研究概览
简要总结
Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.
For bowel preparation, effective, well-tolerated and safe methods should be applied.
Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
详细描述
For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age, between 20 and 75
- •Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy
排除标准
- •Gastrointestinal obstruction
- •Bowel perforation
- •Gastric retention
- •Toxic colitis or toxic megacolon
- •Known allergies to components of the OSS and PEG-Asc
- •History of colorectal resection
- •History of abdominopelvic surgery within 6 months
- •uncontrolled electrolyte imbalance
- •hereditary Phenylketonuria
- •Severe dehydration status
- •Glucose-6-phosphate dehydrogenase deficiency
研究组 & 干预措施
HAPREP® (PEG-Asc)
subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation
: PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]
干预措施: HAPREP® (Drug)
SUCLEAR® (OSS)
subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation
: OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
干预措施: SUCLEAR® (Drug)
结局指标
主要结局
Adequacy of bowel preparation
时间窗: on the day of colonoscopy
次要结局
- adenoma detection rate(whithin 3 weeks from the day of colonoscopy)
- 5-point scale symptom questionnaire for drug tolerability(on the day of colonoscopy)
- Number of Participants with Adverse Events(on the day of colonoscopy)
- colonoscopy insertion time(on the day of colonoscopy)
研究者
Dae Kyung Sohn
M.D., PhD
National Cancer Center, Korea