bowel preparation before colonoscopy
Conditions
Interventions
Trade Name: Picoprep
Pharmaceutical Form: Powder for oral solution in sachet
Trade Name: Kleanprep
Pharmaceutical Form: Oral powder in sachet
Sponsors
Kennemer Gasthuis, afdeling maag-, darm-, leverziekten
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatient patients. Competent patient. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Age >80 or 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether there is a difference in efficacy of bowel preparation between the products PicoPrep and Kleanprep.;Secondary Objective: Compare patientsatisfaction and severity of side effects between products PicoPrep and KleanPrep. Total inspection time and caecum intubation are registered because these are indicators of quality of the colonoscopy. ;Primary end point(s): Primary study 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. ;Timepoint(s) of evaluation of this end point: The gastroenterologist performing the colonoscopy of the patient will score the efficacy of bowel preparation using a scoring device which scores how clean the bowel is during inspection. This device is the Boston Bowel Preparation Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •patientsatisfaction •severity of side effects •caecumintubation •inspection time •BBPS score per bowelsegment, per time of colonoscopy (morning/AM or afternoon/PM) •total amount of liquid patients drink;Timepoint(s) of evaluation of this end point: BBPS score, inspection time en caecum intubation are noted by the performing gastroenterologist on a form after finishing the colonoscopy. Patientsatisfaction is scored by patient on a questionnary by answering 2 questions: flavour and convenience of use, the questions have a 5 point Likert-scale Most common side effects (nausea, vomiting, abdominal pain, headache, bloating and dizziness) are scored by patients on a questionnary with a 4 point Likert scale for severity. total amount of liquid patients drink they score on a 4 point scale in the questionnary. Patients fill out the questionnary after using the bowel preparation product. | — |
Countries
Netherlands
Contacts
Public Contactuitvoerend onderzoeker
Kennemer Gasthuis, afdeling maag-, darm- en leverziekten
Outcome results
None listed