To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
- 试验地点
- 1
- 主要终点
- Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
研究概览
简要总结
Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.
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
- Double (Care Provider, Investigator)
盲法说明
The endoscopist who performs the colonoscopy and the investigator who acts as second observer are blinded to objectively assess the BBPS.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient referred for diagnostic colonoscopy
- •Age between 40 and 85 years old
- •Ability of normal oral ingestion
- •Able to give informed consent by the patient or the legal representative
排除标准
- •Participant has a history of (partial) colectomy, excluding appendectomy
- •Inability of oral ingestion
- •Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
- •Uncontrolled coagulopathy
- •Pregnancy
- •Premenopausal women not adhering to any contraceptive method
- •Inflammatory bowel disease
- •Lynch syndrome
- •Familial adenomatosis polyposis syndrome
- •Serrated polyposis syndrome
- •hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1
- •gastrointestinal obstruction or perforation
- •gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.)
- •phenylketonuria (due to the presence of aspartame in PLENVU)
- •glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU)
- •toxic megacolon
- •Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
研究组 & 干预措施
Lenient diet
This group can have a less stringent diet compared to the current standard of care and eat a light meal until 18h before drinking the first dose of the bowel preparation on the day before the colonoscopy
干预措施: Lenient diet (Behavioral)
Control group
This group follows the strict diet similar to what is currently used in standard of care.
结局指标
主要结局
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
时间窗: Max 12 weeks
次要结局
- Number of patients with an optimal bowel preparation (BBPS 8-9)(Max 12 weeks)
- Detection rates(Max 12 weeks)
- Number of patients with high-quality right sided colon preparation (subscore = 3)(Max 12 weeks)
- Overall patient's tolerance, adherence and satisfaction based on the patient's diary(Max 12 weeks)