No registrations found.
ID
Source
Health condition
colonoscopy, colon cancer screening, bowel preparation
coloscopie, darmkanker screening, darmvoorbereiding
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
Preparation 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.
Background summary
In 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.
Study objective
Colonoscopy 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.
Study design
Quality 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.
Intervention
One 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.
Academic Medical Centre<br>
Meibergdreef 9
John Stadwijk
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664302
j.s.stadwijk@amc.uva.nl
Academic Medical Centre<br>
Meibergdreef 9
John Stadwijk
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664302
j.s.stadwijk@amc.uva.nl
Inclusion criteria
Outpatients, 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 criteria
Patients 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3798 |
| NTR-old | NTR3971 |
| CCMO | NL37970.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37589 |