Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study
| العنوان: | Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study |
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| المؤلفون: | Stefan Schubert, Michael Blaker, Gillaume Bonnaud, Imke Behnken, Michael Klemt-Kropp, T. Klugmann, Eric T.P. Keulen, Michael Mross, Thierry Ponchon, Meredin Stoltenberg, Ralf Kiesslich, Marcel J M Groenen, Wilfred Landry |
| المصدر: | Endoscopy International Open, Vol 05, Iss 04, Pp E282-E290 (2017) Endoscopy International Open |
| بيانات النشر: | Georg Thieme Verlag KG, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | medicine.medical_specialty, Original article, medicine.medical_treatment, Colon cleansing, Colonoscopy, Pharmacology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Clinical endpoint, medicine, media_common.cataloged_instance, Ascending colon, Pharmacology (medical), Dosing, European union, lcsh:RC799-869, media_common, medicine.diagnostic_test, business.industry, Regimen, Tolerability, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, lcsh:Diseases of the digestive system. Gastroenterology, business |
| الوصف: | 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 Conclusion The TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692 |
| اللغة: | English |
| تدمد: | 2196-9736 2364-3722 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8ad9f86e685815d3f1b0764e9577ccf2Test http://www.thieme-connect.de/DOI/DOI?10.1055/s-0043-102433Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8ad9f86e685815d3f1b0764e9577ccf2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 21969736 23643722 |
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