A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu (DinNER1006)

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

Conditions: Healthy; Bowel Preparation for Colonoscopy; Bowel Cleansing for Colonoscopy; Bowel Preparation

Treatments: Behavioral: Lenient diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06651398

S66191

Details and patient eligibility

About

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.

Enrollment: 525 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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525 participants in 2 patient groups

Lenient diet

Experimental group

Description:

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

Treatment:

Behavioral: Lenient diet

Control group

No Intervention group

Description:

This group follows the strict diet similar to what is currently used in standard of care.