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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37589
Enrollment
340
Registered
2012-07-17
Start date
2012-11-27
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)