Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Bloating score 1 hour after the colonoscopy
研究概览
简要总结
Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.
详细描述
Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.
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 (Participant, Investigator, Outcomes Assessor)
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
- •known diagnosis of Crohn´s disease and ulcerative colitis
- •indication for diagnostic colonoscopy
- •informed consent
- •unsedated or minimally sedated procedure (< 3 mg of midazolam)
排除标准
- •planned incomplete or therapeutic procedure
- •deep sedation or general anesthesia
- •intestinal resection longer than ileocecal resection
- •isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
- •ulcerative proctitis (E1)
结局指标
主要结局
Bloating score 1 hour after the colonoscopy
时间窗: 1 hour
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy
次要结局
未报告次要终点
研究者
Premysl Falt, M.D., Ph.D.
Premysl Falt, M.D., Ph.D.
Vitkovice Hospital