A European, multicentre, observational, post-authorisation safety study of oral sulphate solution: compliance and safety.

ABSTRACT: Background and study aims  Oral sulphate solution (OSS) is a sulphate-based, low-volume bowel cleansing preparation taken in two doses of 500 mL, each followed by 1000mL of water or clear liquid. The primary objective of this observational study was to document compliance with the recommended hydration guidelines in a representative sample of the European population. Patients and methods  Prospective, non-interventional, multicentre study (NCT02630680, EUPAS9361) in patients prescribed OSS for colonoscopy preparation in routine clinical practice in Europe. Patients were included according to pre-agreed consecutive enrolment rules. Patients recorded the volume of OSS and water or clear liquid intake, and occurrence of adverse events (AEs). Compliance with hydration was calcula

SUBMITTER: Regula J 

PROVIDER: S-EPMC7055619 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature