To demonstrate that the small dose of Picoprep (2 times 150 ml with 3-4 litres of clear fluids) is as efficacious for bowel cleansing as small dose Moviprep (PEG) (2 litre with 2 litres of clear fluids) and that Picoprep is as safe as Moviprep and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
diagnostiek van poliepen, ontstekingen, bloedingen in het colon
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Colonoscopy is considered the reference standard for the detection of colonic
neoplasia. Polyp detection is dependent on quality standards including
colonoscopist and patient related factors. Optimal bowel preparation is
associated with lower polyp miss rates. Improving tolerability of bowel
cleansing may encourage patient compliance. Lowering the intake of bowel
preparation would increase patient tolerability. We hypothesize that the small
dose of Picoprep is as efficacious for bowel cleansing as small dose of
Moviprep (PEG) and that Picoprep is as safe as Moviprep and may be more
tolerable for patients.
Study objective
To demonstrate that the small dose of Picoprep (2 times 150 ml with 3-4 litres
of clear fluids) is as efficacious for bowel cleansing as small dose Moviprep
(PEG) (2 litre with 2 litres of clear fluids) and that Picoprep is as safe as
Moviprep and may be more tolerable for patients.
Study design
This is a single-blind parallel randomized controlled trial of patients
undergoing colonoscopy because of complaints, polyp follow-up, colon cancer
screening, surveillance of familial cancer and inflammatory bowel disease, in a
setting of an academic hospital. Patients will receive the information about
coloscopy and bowel preparation and will be asked to participarte in this study
where they will receive either Picoprep or Moviprep.
Study burden and risks
The burden is the need of blood sampling twice and a telephone call after 30
days. Also they have to fill out a questionnaire which will take 10 minutes.
The benefit is the possibility of a less invasive and more effective bowel
preparation in the near future which may be advantageous not only for the group
but also for the patient as she/he will need (most of the time) a repeat exam
in the near future.
Polarisavenue 130
2132 JX Hoofddorp 1105 AZ
NL
Polarisavenue 130
2132 JX Hoofddorp 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004384-75-NL |
| CCMO | NL37970.018.11 |
| OMON | NL-OMON23520 |