A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 9
- 主要终点
- Number of Participants with increased Disease activity after colonoscopy.
研究概览
简要总结
The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.
- •Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.
排除标准
- •The diagnosis is not definite.
- •Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.
- •Patients after colon surgery.
- •Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.
- •Patients can not cooperate with the use of polyethylene glycol or glycerin enema.
- •Patients or family members cannot understand the conditions and objectives of this study.
研究组 & 干预措施
Modified bowel preparation method group
One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken
干预措施: Polyethylene Glycols (Drug)
Traditional bowel preparation method group
Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)
干预措施: Polyethylene Glycols (Drug)
结局指标
主要结局
Number of Participants with increased Disease activity after colonoscopy.
时间窗: Within 7 days after colonoscopy
Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.
The quality of bowel preparation evaluated by endoscopists during colonoscopy.
时间窗: During colonoscopy examination
The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).
次要结局
- Number of Participants hospitalized because of aggravation of disease after colonoscopy.(Within 30 days after colonoscopy)
- Tolerance score of participants after bowel preparation.(After bowel preparation and before colonoscopy)
- Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.(Within 30 days after colonoscopy)