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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06651398
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-14
• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 525

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)	Max 12 weeks

Secondary Outcome Measures

Name	Time	Method
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
Number of patients with an optimal bowel preparation (BBPS 8-9)	Max 12 weeks

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium