Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 553
- 试验地点
- 5
- 主要终点
- Adequate bowel cleansing
研究概览
简要总结
Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is necessary to carry out a preparation as safe and tolerable as possible. This preparation generally consists in a low residue diet the days before the colonoscopy and in the intake of a laxative solution. In previous studies, it has been shown that the low residue diet does not play a relevant role as it was considered before. Recent studies demonstrated that reducing the days of low residue diet does not worsen the cleansing and improves the patient experience. The results of this study are required for determining the role of diet restrictive diet in colon cleansing.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)
排除标准
- •Individuals in which colonoscopy, cleansing solution or bisacodyl are contraindicated
- •Subjects that are considered to have a linguistic barrier or to be unable to understand the instructions and / or give informed consent.
研究组 & 干预措施
Unrestricted diet
The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.
干预措施: Unrestricted diet before colonoscopy (Other)
Unrestricted diet
The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.
干预措施: Bisacodyl 5 MG (Drug)
One day low residue diet
The participant is instructed to follow a low residue diet the day before the colonoscopy.
It will be given a informative document and educated by a nurse.
干预措施: 1-day low residue diet (Other)
One day low residue diet
The participant is instructed to follow a low residue diet the day before the colonoscopy.
It will be given a informative document and educated by a nurse.
干预措施: Bisacodyl 5 MG (Drug)
结局指标
主要结局
Adequate bowel cleansing
时间窗: During colonoscopy (At the withdrawal phase)
Bowel cleansing as a rating using the Boston Bowel Preparation Scale above 1 in each segment . This score ranges fron 0 to 3 in each one of the three segments. Zero is the worst outcome and 3 is the best cleansing
次要结局
- Rate of colonoscopies with adenoma(With histology report, an average of 4 weeks after colonoscopy)
- Information perceived quality assessed by a likert scale(The day of the colonoscopy just before beginning)
- Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale(During colonoscopy (At the entry phase))
- Diet tolerability as assessed by a likert scale(The day of the colonoscopy just before beginning)
- Preparation tolerability as assessed by a likert scale and Hatoum et al. survey(The day of the colonoscopy just before beginning)
- Rate of colonoscopies with polyps(During colonoscopy)
- Cecal intubation time(During colonoscopy)
- Withdrawal time(During colonoscopy)
- Rate of colonoscopies with flat polyps(During colonoscopy)
研究者
Salvador Machlab
Gastroenterology Consultant
Parc Taulí Hospital Universitari