Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Comparison efficacy of bowel preparation before colonoscopy between 2 group
研究概览
简要总结
Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen
详细描述
The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging
Randomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram.
Group 2 the participant recieved Polyethylene 4 liter split dose
Result of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale
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
- Double (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
- •Adute aged 18-80 year old
- •Indication for colonoscopy(one selected)
- •Colorectal cancer screening
- •Stool occult blood test positive
- •History of colonic polyp
- •abdominal pain
- •Iron deficiency anemia
- •Chronic diarrhea
- •chronic constipation
- •Unintentional weight loss
- •Gastrointestinal bleeding
- •Abnormal imagind study
- •Participant acceptconsent information
排除标准
- •Pregnancy or lactation
- •Gastroparesis, gastric outlet obstuction
- •Bowel obstruction
- •Gastrointestinal tract surgery
- •Inflammatory bowel disease
- •ASA(American society of anesthesiologist physical status) status > or = 4
- •Allergic to Elobixibat or PEG
- •Chronic kidney disease stage 4-5(GFR <30 ml/min)
- •Biliary tract obstruction
- •Previous history of inadequate bowel preparation
研究组 & 干预措施
2-Liter polyethylene glycol plus elobixibat
Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.
干预措施: 2-Liter polyethylene glycol plus elobixibat (Drug)
4-Liter polyethylene glycol
Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.
干预措施: 4-Liter polyethylene glycol (Drug)
结局指标
主要结局
Comparison efficacy of bowel preparation before colonoscopy between 2 group
时间窗: During colonoscopy procedure
Bowel preaparation measure by Boston bowel preparation scale
次要结局
- Patient satisfaction in their bowel preparation regimen(1 day before colonoscopy)
- Cecal intubation rate(During colonoscopy procedure)
- Adenoma detection rate(During colonoscopy procedure)
- Adverse event in each group(During 24 hour after taking bowel preparation)
- Overall procedural time of colonoscopy(During colonoscopy procedure)
- Withdrawal time of colonoscopy(During colonoscopy procedure)