Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy: a Multicenter Non-inferiority Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 27
- 主要终点
- Adequate bowel preparation rate
研究概览
简要总结
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.
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
- Double (Investigator, Outcomes Assessor)
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
- •adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.
排除标准
- •severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months.
- •a history of abdominal or pelvic surgery, BMI > 28 or BMI < 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction.
- •imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
研究组 & 干预措施
Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol
干预措施: Low-residue full nutrition formula podwer (Dietary Supplement)
Self-prepared low-residue diet combined with 3 liters of polyethylene glycol
干预措施: Self-prepared low-residue diet (Dietary Supplement)
结局指标
主要结局
Adequate bowel preparation rate
时间窗: Two months
Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
次要结局
- Excellent bowel preparation rate(Two months)
- Bowel preparation completion rate(Two weeks)
- Subject satisfaction rate(Two weeks)
- Colonoscopist satisfaction rate(Two weeks)
- Adenoma detection rate(Four weeks)
- Polyp detection rate(Two weeks)
- BBPS score (including total score, left colon, transverse colon, and right colon)(Two months)
- Aronchick Scale score(Two months)
- Compliance with FNFP(Two weeks)
研究者
Zhaoshen Li
Director of the Department of Gastroenterology, the First Affiliated Hospital of Naval Medical University
Changhai Hospital