Clinical trial NCT06651398: A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu
Official title: To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bowel Preparation
Bowel Preparation for Colonoscopy
Bowel Cleansing for Colonoscopy
Healthy
Keywords: bowel preparation
colonoscopy preparation
bowel cleansing
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Norgine BV
First posted: 2024-10-21
Enrollment: 525
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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
* ileus
* 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

Primary outcomes:
measure: Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
timeFrame: Max 12 weeks
Secondary outcomes:
measure: Number of patients with an optimal bowel preparation (BBPS 8-9)
timeFrame: Max 12 weeks
measure: Detection rates
timeFrame: Max 12 weeks
measure: Number of patients with high-quality right sided colon preparation (subscore = 3)
timeFrame: Max 12 weeks
measure: Overall patient's tolerance, adherence and satisfaction based on the patient's diary
timeFrame: Max 12 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References: