Comparing bowel cleansing agents Plenvu and Picoprep before colonoscopy
A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
PHASE4 · Aalborg University Hospital · NCT05436054
This study is testing whether Plenvu or Picoprep works better and is easier to handle for people getting ready for a colonoscopy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital (other) |
| Locations | 1 site (Aalborg, North Jutland) |
| Trial ID | NCT05436054 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the efficacy and tolerability of two bowel cleansing agents, Plenvu and Picoprep, prior to colonoscopy. A total of 400 patients referred for colonoscopy at a single center in North Jutland will be randomly assigned to receive either Plenvu or Picoprep. Participants will complete a questionnaire regarding expected side effects and their experience with the bowel cleansing agents. The quality of bowel cleansing will be assessed using a blinded scoring system to ensure unbiased evaluation by the colonoscopist.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for an ambulatory colonoscopy.
Not a fit: Patients with severe heart or renal failure, pregnant or breastfeeding individuals, and those with specific gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bowel preparation methods, enhancing the effectiveness of colonoscopies and potentially increasing the detection rates of colonic lesions.
How similar studies have performed: Previous studies have shown varying success with different bowel cleansing agents, but this specific comparison of Plenvu and Picoprep is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulant colonoscopy * Older than18 Exclusion Criteria: * Younger than 18 * Known with severe heart failure * Known with severe renal failure (eGFR\<30) * Known for colonic stenosis * Pregnant or breastfeeding * Acute colonoscopy * Cancer screening program colonoscopy * Mentally retarded * Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation. * Patients with Phenylketonuria * Patients with Glucose-6-phosphate-dehydrogenase deficiency * Patients with colon or rectum resection
Where this trial is running
Aalborg, North Jutland
- Aalborg University hospital — Aalborg, North Jutland, Denmark (RECRUITING)
Study contacts
- Study coordinator: Hayder Alqaisi
- Email: haidermahmoud1991@gmail.com
- Phone: +4591637005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Disease, colonoscopy, bowel cleansing