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Active, Not Recruiting

NCT Number: NCT06651398

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bowel Preparation Bowel Cleansing for Colonoscopy Bowel Preparation for Colonoscopy Healthy

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Max 12 weeks

Secondary outcomes

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

    Time frame: Max 12 weeks

  2. Detection rates

    Time frame: Max 12 weeks

    Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), Serrated Polyp Detection Rate (SPDR), Advanced Adenoma Detection Rate (aADR)

  3. Number of patients with high-quality right sided colon preparation (subscore = 3)

    Time frame: Max 12 weeks

  4. Overall patient's tolerance, adherence and satisfaction based on the patient's diary

    Time frame: Max 12 weeks

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Norgine BV

Registry information

Official study title

To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy

Acronym: DinNER1006

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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