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Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.


ABSTRACT: Background and study aims?The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods?Patients (??18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10?-?18 hours; Dose 2, 4?-?6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6?-?8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0?-?14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [??2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results?Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95?% confidence intervals [CI]:?-?4.99,?-?2.97; P?

SUBMITTER: Kiesslich R 

PROVIDER: S-EPMC5382934 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

Kiesslich Ralf R   Schubert Stefan S   Mross Michael M   Klugmann Tobias T   Klemt-Kropp Michael M   Behnken Imke I   Bonnaud Gillaume G   Keulen Eric E   Groenen Marcel M   Blaker Michael M   Ponchon Thierry T   Landry Wilfred W   Stoltenberg Meredin M  

Endoscopy international open 20170401 4


<b>Background and study aims</b> The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. <b>Patient and methods</b> Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 - 18 hours; Dose 2, 4 - 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before co  ...[more]

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