NCT03763266已完成不适用
Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial
Parc Taulí Hospital Universitari2 个研究点 分布在 1 个国家目标入组 858 人开始时间: 2018年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 858
- 试验地点
- 2
- 主要终点
- Bowel preparation
研究概览
简要总结
Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.
The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.
The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the colorectal cancer screening program that give consent
排除标准
- •Contraindication for colonoscopy
结局指标
主要结局
Bowel preparation
时间窗: During the colonoscopy
Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.
次要结局
- Endoscopic diagnosis(It is assessed during the colonoscopy and will be reported the same day.)
- Diet tolerance(It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.)
- Withdrawal time(it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure))
- Adenoma detection rate(up to 2 weeks after colonoscopy depending on pathology department workload.)
- Intubation time(it is assessed from the start of the colonoscopy until cecum is reached (1 day))
- Cecum intubation rate(It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done)
- Preparation tolerance(It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.)
研究者
Salvador Machlab
Principal Investigator
Parc Taulí Hospital Universitari
研究点 (2)
Loading locations...
相似试验
已完成
不适用
3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient TolerabilityColon DiseaseColonic NeoplasmsNCT02955901Portuguese Oncology Institute, Coimbra412
已完成
不适用
Unrestricted Diet for Screening ColonoscopyBowel CleansingColonoscopyBowel CancerNCT05032794Parc Taulí Hospital Universitari553
已完成
不适用
A Low-residue Diet vs Clear Liquid Diet as a Bowel Colonoscopy Preparation With Polyethylene Glycol (PEG)ColonoscopyNCT03358537Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran215
已完成
不适用
Comparison of Bowel Cleansing Regimens for ColonoscopyColonoscopy PreparationNCT06021639Mersin University144
终止
不适用
Efficacy of Free Versus Low Residue Diet as Preparation for Screening ColonoscopyColon PolypColon AdenomaColorectal CancerNCT04664543Parc Taulí Hospital Universitari100