Randomized controlled trial: Picoprep versus Moviprep for efficacy, safety and patient tolerability in colonoscopy bowel preparation.

Completed

Conditions: colonoscopy
quality of colon cleansing
diagnostiek van poliepen, ontstekingen, bloedingen in het colon

Registration Number: NL-OMON37589

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 340

Inclusion Criteria

Patient 18 years and older, who have to uindergo a colonoscopy and who are able to give their informed consent and are eligible to undergo bowel-cleansing

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. Also, patients with a subtotal colectomy or a colostomy will be excluded because of insufficient remaining colonic surface to evaluate the effects of bowel cleansing.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Preparation efficacy is evaluated by the blinded colonoscopist. Bowel<br /><br>preparation is assessed by the validated Ottawa Bowel Preparation Scale, the<br /><br>Aronchick scale and the Boston Bowel Preparation Scale based on the preparation<br /><br>scores from three segments of the colon (right colon, transverse colon and left<br /><br>colon), as well as a score for overall colonic fluid. Quality measures of<br /><br>colonoscopy are reported such as caecal intubation, intubation and withdrawal<br /><br>times, polyp detection rate and complications. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events will be recorded for 30 days after colonoscopy. Blood will be<br /><br>collected after the preparation and right before the procedure to assess<br /><br>electrolyte shifts and will be tested for bicarbonate, blood urea nitrogen,<br /><br>calcium, chloride, creatinine, magnesium, phosphate, potassium, sodium,<br /><br>haemoglobin and hematocrite. A questionnaire is used to assess tolerance of the<br /><br>bowel preparation. This questionnaire will assess complaints such as bloating,<br /><br>cramping, nausea and overall burden such as impedement of activities,<br /><br>interrupted sleep at night and problems in transport to the hospital. All items<br /><br>are scored on a 5-point Likert scale</p><br>