Impact of Low Fiber Diet on Colonic Cleansing Quality Prior to Colonoscopy: Randomized Study Comparing 1 Day Versus 3 Days of Low Fiber Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet.
Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.
详细描述
It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid diet. However, tolerance is better with low fiber diet. There is no current evidence whether the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing quality.
This is the first controlled, randomized trial to compare bowel cleansing by using two different protocols: one day low fiber diet versus three day low fiber diet.
A researcher will offer to participate in the study to scheduled for outpatient colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. Thus, according to the allocation group, participants must comply with a low fiber diet the previous day of the examination or 3 days prior to the examination. In both cases, patients will take a liquid diet the night before.
Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with ascorbic acid 5 hours before the appointment for colonoscopy.
Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.
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
- Single (Investigator)
盲法说明
Only the endoscopists in charged of rating cleansing quality during colonoscopy will be masked.
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
- •Age ≥ 18 years
排除标准
- •Patients with previous colon surgery
- •Last colonoscopy with poor bowel preparation
- •Ileus, intestinal obstruction, megacolon
- •Poorly controlled hypertension (HTAS> 180 HTAD> 100)
- •Terminal renal failure (pre-dialysis or dialysis)
- •Congestive heart failure (NYHA III-IV)
- •Acute liver failure
- •Severe psychiatric illness
- •Dementia with difficulty in the intake of the preparation
- •Pregnancy or breastfeeding
- •Phenylketonuria
- •Deficiency of glucose-6-phosphate dehydrogenase
- •Refusal to participate in the study
- •Inability to follow the instructions
研究组 & 干预措施
One-day low fiber diet
Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
干预措施: One-day Low fiber diet (Other)
One-day low fiber diet
Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
干预措施: Polyethylene Glycol plus ascorbic acid (Drug)
Three-day low fiber diet
Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
干预措施: Three-day low fiber diet (Other)
Three-day low fiber diet
Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered
干预措施: Polyethylene Glycol plus ascorbic acid (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: 7 months
This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points
次要结局
- Proportion of polyps detected in each arm(7 months)
- Degree of satisfaction with diet(7 months)