To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 525
- Locations
- 2
- Primary Endpoint
- Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Investigator)
Masking Description
The endoscopist who performs the colonoscopy and the investigator who acts as second observer are blinded to objectively assess the BBPS.
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
Time Frame: Max 12 weeks
Secondary Outcomes
- 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)