NCT06298461招募中4 期
Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Quality of bowel cleanliness
研究概览
简要总结
The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
- •Age > 18 years
- •Out-patients
排除标准
- •Prior subtotal or total colorectal resection
- •Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
- •Colonoscopy being repeated because of poor preparation in the preceding six months.
- •Allergies to the employed bowel preparations
- •Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
- •IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients.
研究组 & 干预措施
OSS
Active Comparator
干预措施: KleanLyte (Drug)
2L PEG
Active Comparator
干预措施: Bi-PegLyte (Drug)
结局指标
主要结局
Quality of bowel cleanliness
时间窗: 1 year
The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by the Ottawa scale score as a binary adequate/inadequate score (≤7) will be recorded.
次要结局
- Volume of laxative intake(1 year)
- Endoscopic Outcomes(1 year)
- Patient experience data(1 year)
- Crohn's disease or ulcerative colitis flares after colonoscopy(One month)
研究者
研究点 (1)
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