Bowel Cleansing for Colonoscopy, Bowel Preparation, Bowel Preparation for Colonoscopy, Healthy
Conditions
Keywords
bowel preparation, colonoscopy preparation, bowel cleansing
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.
Interventions
BEHAVIORALLenient diet
The interventional goup receives the lenient diet instructions and will eat a light meal until 18h on the day before the colonoscopy. The first dose of Plenvu will be started at 20h. All the other bowel preparation instructions will be the same as in the control group.
Sponsors
Norgine BV
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, 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
Sex/Gender
ALL
Age
40 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1) | Max 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with an optimal bowel preparation (BBPS 8-9) | Max 12 weeks | — |
| Detection rates | Max 12 weeks | Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), Serrated Polyp Detection Rate (SPDR), Advanced Adenoma Detection Rate (aADR) |
| 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 | — |
Countries
Belgium
Outcome results
None listed