To determine which bowel preparation product is superior in cleansing the colon and in patient satisfaction.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
darmreiniging voor coloscopie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
efficacy of cleansing product, measured by how clean the bovwel is during
inspection, based on a ordinal scale of the Boston Bowel preparation scale.
Secondary outcome
Secundary study outcomes: Patient satisfaction, determined by users convenience
and taste. The severity of side effects.
Total inspection time and coecumintubation are also registered.
Background summary
To visualise the mucosa of the bowel during colonoscopy the bowel has to be
empty. Therefore patients drink a bowel preparation product before colonoscopy,
which empties the bowel. KleanPrep is the most commonly used bowel preparation
product in the Netherlands. The disadvantage is that patients find it hard to
use and the taste isn't good. PicoPrep is another registered bowel preparation
product. This product has a better patient satisfaction.
Previous research there wasn't a direct comparison of split-dose regimes, the
studies were very diverse in design and used subjective outcome measurements
for efficacy. So no conclusions can be made yet in the comparison of efficacy
between the products.
Study objective
To determine which bowel preparation product is superior in cleansing the colon
and in patient satisfaction.
Study design
Randomised single-blinded single-center research
Intervention
Randomisation between PicoPrep and KleanPrep. KleanPrep is the standard bowel
preparation product used in the Kennemer Gasthuis at this moment.
Efficacy will be determined using the Boston Bowel Preparation Schale. Patient
satisfaction and severity of side effects will be determined using a
questionnary.
Study burden and risks
Participation in this study means almost no extra burden for the patient. Only
a short questionnary has to be filled in by the patient.
There are no extra visits to the hospital or extra medical interventions.
There are no extra risks for the patient when participating, because the
products are registered en safe for use in bowel preparation.
There is of course always a chance that people suffer from side effects.
Boerhaavelaan 22
Haarlem 2035 RC
NL
Boerhaavelaan 22
Haarlem 2035 RC
NL
Listed location countries
Age
Inclusion criteria
Outpatient patients. Competent patient. Signed informed consent.
Exclusion criteria
Age >80 or < 18 years, serious heart failure (NYHA class > 2), known allergy for bowel preparation products, known serious renal failure (MDRD <30), colorectal surgery in history, known serious constipation (less than three bowel movements a week), ileus, pregnancy/lactation, active inflammatory bowel disease.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004327-21-NL |
| CCMO | NL42121.094.12 |