Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation rate
研究概览
简要总结
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age is between 18-
- •Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- •Patients who have signed inform consent form
排除标准
- •subjects who had known or suspected heart failure, stroke or renal failure;
- •subjects who had a history of colon surgery or inflammatory bowel disease;
- •subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
- •subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
- •subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
- •subjects who had participated in another interventional clinical trial in the previous 60 days;
- •pregnant or lactating women and those planning to become pregnant.
结局指标
主要结局
Adequate bowel preparation rate
时间窗: 30 mins
Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.
BBPS scores of the entire colon
时间窗: 30 mins
The sum of the scores of three bowel segment.
次要结局
- preparation completion rate(1 day)
- adenoma detection rate (ADR)(30 mins)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital