Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- adequate bowel preparation rate
研究概览
简要总结
The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.
详细描述
Step 1: During the issuance of a colonoscopy order, outpatient/ward physicians conduct preliminary screening and introduction to potential participants. Alternatively, recruitment may take place during follow-up in the recovery room or ward after the patient completes the colonoscopy (must be within 7 days post-procedure to reduce recall bias). Provide detailed explanations of the study content, risks, and benefits to potential subjects.
Step 2: Ensure that the patient fully understands the study, and then proceed to sign the "Informed Consent Form."
Step 3: Patients complete the "Questionnaire on Factors Influencing Bowel Preparation in IBD Patients." The questionnaire covers two main aspects: First, potential risk factors that may affect the quality of bowel preparation, including BMI, history of abdominal surgery, history of diabetes, history of diarrhea or constipation, stool characteristics, etc. Second, the specific bowel preparation protocol, including pre-colonoscopy diet, type of bowel cleansing agent used, dosage, interval between completion of medication and start of colonoscopy (waiting time), timing of medication intake, etc. Finally, the researcher records the bowel preparation quality score and colonoscopy results, including Boston Bowel Preparation Scale scores for each intestinal segment, colonoscopic diagnosis, endoscopic disease activity scores, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or older, of any gender, scheduled for colonoscopy;
- •Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
- •Voluntary participation in this study and provision of signed informed consent.
排除标准
- •History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;
- •Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;
- •Pregnant or lactating women;
- •Acute intestinal infection within the past 2 weeks;
- •History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;
- •History of intestinal obstruction, perforation, stenosis, or any other condition preventing completion of the examination;
- •Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the survey;
- •Individuals already enrolled in this study who schedule a repeat colonoscopy;
- •Currently participating in another clinical observational trial or having participated in any other clinical trial within the past 60 days;
- •Refusal to sign the written informed consent form.
研究组 & 干预措施
Observational Cohort for Bowel Preparation in IBD Patients
Patients aged 18 years or older diagnosed with Inflammatory Bowel Disease (IBD) and scheduled for a colonoscopy, who undergo standard bowel preparation procedures followed by colonoscopy examination and questionnaire completion.
干预措施: Standard Pre-colonoscopy Bowel Preparation Protocol (Other)
结局指标
主要结局
adequate bowel preparation rate
时间窗: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.
次要结局
- Patient Satisfaction(immediately upon completion of colonoscopy)
- Patient Satisfaction(immediately upon completion of colonoscopy)