A 3-day Versus 1-day Low Residue Diet to Improve Colonoscopy Preparation Result and Patient Tolerability: A Prospective, Randomized, Single-blinded, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 412
- 试验地点
- 2
- 主要终点
- Score of mucosal visualization
研究概览
简要总结
Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing regimens, study of patient-related risk factors to fail a proper preparation and diet adaptations have been studied recently.
A low residue diet is the standard in the day before the colonoscopy. Some endoscopists prescribe this dietary plan for a 3-day period prior to the exam, although no study compared the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation results.
The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.
详细描述
a. Study type: prospective, randomized, single-blinded trial:
i. Prospective inclusion of ambulatory patients;
ii. Randomization by computer generated tables;
iii. Allocation concealment by sealed, opaque envelopes;
iv. Patient not blinded to diet;
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive series of patients scheduled for total colonoscopy
- •Signed informed consent
排除标准
- •inpatients
- •urgent procedures
- •colonoscopies not intended to reach the caecum
- •patient with previous partial colectomy.
研究组 & 干预措施
3-day low residue diet
Group A - 3 day low residue diet prior to the colonoscopy
干预措施: 3 day low residue diet prior to the colonoscopy (Other)
1-day low residue diet
Group B - 1 day low residue diet prior to the colonoscopy
干预措施: 1 day low residue diet prior to the colonoscopy (Other)
结局指标
主要结局
Score of mucosal visualization
时间窗: 1 day (during colonoscopy)
Using Boston Bowel Preparation Scale during the exam
次要结局
- Cecum intubation rate(1 day (during colonoscopy))
- Patient assessment of diet protocol(1 day (the day of the exam))
- Polyp detection rate, location and configuration(1 day (during colonoscopy))
- Adenoma Detection Rate(Within 30 days from colonoscopy date)
- Withdrawal time(1 day (during colonoscopy))
研究者
Filipe Taveira
Principal Investigator
Portuguese Oncology Institute, Coimbra