Bowel Cleansing
Conditions
Brief summary
The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life setting in a representative sample of the European target population.
Interventions
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. * Patient having provided written informed consent.
Exclusion criteria
* Patient not eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. Specifically, patients in whom there is a contraindication for use of this product, including patients with congestive heart failure, severe renal insufficiency of active inflammatory bowel disease, are not eligible for inclusion in this study. * Patient being prescribed a cleansing bowel preparation other than BLI800 (Eziclen®/Izinova®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of liquid intake | on the day of the colonoscopy | Assessment of non-compliance in terms of insufficient liquid intake. The volume of water and clear liquids taken will be derived from the remaining volumes as recorded on the patient's leaflet and reported by the Investigator. Compliance to the hydration guidelines expressed in terms of a ratio (actual volume taken versus theoretical volume). |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | Up to 2 years |
Countries
Czechia, Germany, Netherlands, Poland
Outcome results
None listed