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van CCT (UK)

van CCT (UK)

Picoprep versus Moviprep.

- candidate number14800
- NTR NumberNTR3971
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2013
- Secondary IDsNL37970.018.11 
- Public TitlePicoprep versus Moviprep.
- Scientific TitleRandomized controlled trial: Picoprep versus Moviprep for efficacy, safety and patient tolerability in colonoscopy bowel preparation.
- hypothesisColonoscopy is considered the reference standard for detection of colonic neoplasia. Polyp detection is dependent on quality standards including endoscopist and patient related factors. Optimal bowel preparation is associated with lower polyp miss rates and thus is one of the patient related factors. Patients have difficulties to comply with the usual 4 litre bowel preparation. A 2 litre bowel preparation is available but the required additional 2 litres of clear fluids remains a problem. Our hypothesis is that a small-volume bowel preparations (Picoprep twice 150 ml with 3-4 litres clear fluids) is equally effective as Moviprep (twice 1000ml with 2 litres clear fluids) in the quality of bowel preparation and is as safe and equally well or even better tolerated and tolerance.
- Healt Condition(s) or Problem(s) studiedColonoscopy, Bowel preparation, Colon cancer screening
- Inclusion criteriaOutpatients, older than 18 years, with an indication to undergo colonoscopy, who can give informed consent and who are able to have bowel cleansing at home.
- Exclusion criteriaPatients with significant gastroparesis or gastric outlet obstruction; ileus; known or suspected bowel obstruction or perforation; severe chronic renal failure (creatinine clearance < 30mL/minute); severe congestive heart failure (AHA class III or IV); toxic colitis or megacolon; pregnant patients or patients giving breastfeeds. Patients with a subtotal colectomy or a colostomy will be excluded because of insufficient remaining colonic surface to evaluate the effects of bowel cleansing.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-mei-2014
- Target number of participants340
- InterventionsOne group receives twice 150 ml of Picoprep and the other group twice 1 litre of Moviprep. Both have to take ample extra clear fluids up to a total of 3-4 litres according to their schedule of bowel preparation and colonoscopy time. Also a 2-day fibre-free diet is recommended.
- Primary outcomeThe primary outcome is the achievement of a good cleansing (Ottawa) score, and quality standards such as the caecal intubation rate, intubation and withdrawal time, polyp detection rate and complications.
- Secondary outcomePreparation tolerance; preparation safety; comparison of the 3 available bowel preparation assessment scales.
Confounders influencing the main outcome and secondary endpoints may be age, gender, the starting time of colonoscopy, BMI, colonic disease (IBD, diverticulosis, stenosis, obstruction, constipation), the presence of disease (diabetes, cirrhosis, CVA, dementia, anemia) and the use medication (calcium channel blockers, tricyclic antidepressants) are studies as well.
- TimepointsQuality of bowel preparation and quality standards once, the day of the colonoscopy. Patient's tolerance via a questionnaire once, at the colonoscopy. Safety twice. by blood measuremnts before taking the preparation and day of the colonscopy.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Ferring Pharmaceuticals Denmark
- PublicationsMathus-Vliegen EM, Kemble UM. A prospective randomized blinded comparison of sodium phosphate and polyethylene glycol-electrolyte solution for safe bowel cleansing. Aliment Pharmacol Ther 2006;23:543-52.
- Brief summaryIn a trial to reduce the patient burden of preparation before colonoscopy, we compared a 4-L macrogol solution with twice 90 ml of sodium phosphate. Doctors preferred the preparation with the 4-L whereas patient prefeerd the small-volume preparation. However, the small-volume preparation appeared not to be safe: calcium, phosphate and potassium levels changed considerably.
- Main changes (audit trail)
- RECORD24-apr-2013 - 14-mei-2017

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