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

NCT06651398 | Active Not Recruiting

• 1 other identifier: S66191
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

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

Keywords

bowel preparation; colonoscopy preparation; bowel cleansing

Outcome Measures

Primary Outcomes (1)

• Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)

  Max 12 weeks

Secondary Outcomes (4)

• Number of patients with an optimal bowel preparation (BBPS 8-9)

  Max 12 weeks

• Detection rates

  Max 12 weeks

• 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

Study Arms (2)

Lenient diet

EXPERIMENTAL

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

Behavioral: Lenient diet

Control group

NO INTERVENTION

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

Interventions

Lenient diet 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.

Lenient diet

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Norgine BV: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The endoscopist who performs the colonoscopy and the investigator who acts as second observer are blinded to objectively assess the BBPS.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: February 14, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

BE (1)