A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
Aalborg University Hospital
400 participants
Oct 1, 2022
INTERVENTIONAL
Conditions
Summary
The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.
Eligibility
Inclusion Criteria2
- Ambulant colonoscopy
- Older than18
Exclusion Criteria12
- 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
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Interventions
200 patients will be randomised to this arm
200 patients will be randomised to this arm
Locations(1)
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NCT05436054