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

NCT ID: NCT06651398

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-11-30

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.

Conditions

Bowel Preparation; Bowel Preparation for Colonoscopy; Bowel Cleansing for Colonoscopy; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Lenient diet

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lenient 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norgine BV

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S66191

Identifier Type: -

Identifier Source: org_study_id