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Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05436054

Comparing Plenvu and Picoprep for Bowel Cleaning Before Colonoscopy to Check for Colon Disease

Led by Aalborg University Hospital · Updated on 2024-11-19

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Aalborg University Hospital

Lead Sponsor

R

Regionshospital Nordjylland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two bowel cleansing agents, Plenvu and Picoprep, used before colonoscopy to check for colon disease, mainly to exclude cancer. This phase 4 trial investigates whether the newer, low-volume Plenvu is at least as effective as the established Picoprep in cleaning the bowel, while also examining patient tolerability and compliance. The study is conducted at a single center in North Jutland with 400 patients referred for colonoscopy. Participants are randomly assigned to receive either Picoprep or Plenvu. Picoprep involves taking two doses dissolved in water before the procedure, with fluid intake totaling approximately 2.3 liters. Plenvu is taken in a two-day regimen with two separate doses dissolved in 500 ml water each, accompanied by additional fluids for a total of 2 liters. Both agents require dietary restrictions before colonoscopy, including avoiding seed-containing foods five days prior and following a fluid diet the day before. During the study, participants complete a questionnaire about side effects and their experience with the bowel preparation before the colonoscopy. The colonoscopist, who does not know which agent was used, assesses bowel cleansing quality using the Harefield Cleansing Scale. Data on efficacy and tolerability are collected and analyzed. Participants are followed for about 30 hours after the last dose. The trial will end once 400 patients have completed participation.

CONDITIONS

Brief Title

A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for outpatient colonoscopy
  • 18 years of age or older
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Severe heart failure
  • Severe kidney failure with eGFR below 30
  • Known colonic stenosis
  • Pregnant or breastfeeding
  • Urgent or acute colonoscopy
  • Colonoscopy as part of cancer screening program
  • Cognitive impairment or mental retardation
  • Repeat colonoscopy after cancellation due to poor bowel preparation
  • Phenylketonuria
  • Glucose-6-phosphate-dehydrogenase deficiency
  • Previous colon or rectum surgery involving resection

Research Team

H

Hayder Alqaisi

L

Lars Andersen

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