Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Inadequate bowel preparation.
研究概览
简要总结
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
详细描述
There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.
All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.
排除标准
- •Unwillingness to participate.
- •Inability to follow instructions
- •Active inflammatory bowel disease
- •Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist
研究组 & 干预措施
Low-residue diet
The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.
干预措施: Low-residue diet (Dietary Supplement)
Usual care
The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet.
Laxative 4 liters polyethylene glycol 4000 in split fashion.
干预措施: Usual care (Dietary Supplement)
结局指标
主要结局
Inadequate bowel preparation.
时间窗: 1 hour after the colonoscopy
The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation
次要结局
- Cecal intubation rate(1 hour after the colonoscopy)
- Adenoma detection rate(1 hour after the colonoscopy)
- Polyp detection rate(1 hour after the colonoscopy)
- Abdominal pain(6 hours after finishing bowel preparation)
- Nausea(6 hours after finishing bowel preparation)
- Hunger(6 hours after finishing bowel preparation)
- Bloating(6 hours after finishing bowel preparation)
- Adverse events(30 days after the colonoscopy)
- Adherence to the planned bowel cleansing method (questionnaire)(6 hours after finishing bowel preparation)
- Acceptability of the preparation (interference with work, leisure activities or sleep(6 hours after finishing bowel preparation)
研究者
Marco Antonio Alvarez Gonzalez
MD
Parc de Salut Mar