학술논문
Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy.
Document Type
Academic Journal
Author
Zorzi M; Veneto Cancer Registry, Regione Veneto, Padua, Italy.; Valiante F; Gastroenterologia ed endoscopia digestiva, ULSS 2, Feltre, Italy.; Germanà B; Dipartimento delle Chirurgie Specialistiche, Gastroenterologia, Ospedale S. Martino, ULSS 1, Belluno, Italy.; Baldassarre G; Endoscopia Digestiva, Ospedale Alto Vicentino, ULSS 4, Santorso, Italy.; Coria B; Centrale Operativa Screening, Servizio Igiene e Sanità Pubblica, ULSS 6, Vicenza, Italy.; Rinaldi M; Gastroenterologia, Ospedale di Conegliano, ULSS 7, Conegliano, Italy.; Heras Salvat H; Gastroenterologia, Ospedale S. Maria di Ca' Foncello, ULSS 9, Treviso, Italy.; Carta A; Endoscopia Digestiva, Chirurgia, ULSS 10, San Donà di Piave, Italy.; Bortoluzzi F; Gastroenterologia, ULSS 12, Venezia, Italy.; Cervellin E; Gastroenterologia, Ospedale di Dolo, ULSS 13, Dolo, Italy.; Polo ML; Centrale Operativa Screening, ULSS 14, Chioggia, Italy.; Bulighin G; Gastroenterologia ed Endoscopia Digestiva, ULSS 20, San Bonifacio, Italy.; Azzurro M; Endoscopia Digestiva e Gastroenterologia, ULSS 21, Legnago, Italy.; Di Piramo D; Gastroenterologia ed Endoscopia Digestiva, ULSS 22, Bussolengo, Italy.; Turrin A; Settore promozione e sviluppo igiene e sanità pubblica, Regione Veneto, Venezia, Italy.; Monica F; Gastroenterologia ed Endoscopia, Azienda Ospedaliero Universitaria 'Ospedali Riuniti,' Trieste, Italy.
Source
Publisher: Georg Thieme Verlag Country of Publication: Germany NLM ID: 0215166 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1438-8812 (Electronic) Linking ISSN: 0013726X NLM ISO Abbreviation: Endoscopy Subsets: MEDLINE
Subject
Language
English
Abstract
Background and Study Aims: The high volume and poor palatability of 4 L of polyethylene glycol (PEG)-based bowel cleansing preparation required before a colonoscopy represent a major obstacle for patients. The aim of this study was to compare two low volume PEG-based preparations with standard 4 L PEG in individuals with a positive fecal immunochemical test (FIT) within organized screening programs in Italy.
Patients and Methods: A total of 3660 patients with a positive FIT result were randomized to receive, in a split-dose regimen, 4 L PEG or 2 L PEG plus ascorbate (PEG-A) or 2 L PEG with citrate and simethicone plus bisacodyl (PEG-CS). The noninferiority of the low volume preparations vs. 4 L PEG was tested through the difference in proportions of adequate cleansing.
Results: A total of 2802 patients were included in the study. Adequate bowel cleansing was achieved in 868 of 926 cases (93.7 %) in the 4 L PEG group, in 872 out of 911 cases in the PEG-A group (95.7 %, difference in proportions + 1.9 %, 95 % confidence interval [CI] - 0.1 to 3.9), and in 862 out of 921 cases in the PEG-CS group (93.6 %, difference in proportions - 0.2 %, 95 %CI - 2.4 to 2.0). Bowel cleansing was adequate in 95.5 % of cases when the preparation-to-colonoscopy interval was between 120 and 239 minutes, whereas it dropped to 83.3 % with longer intervals. Better cleansing was observed in patients with regular bowel movements (95.6 %) compared with those with diarrhea (92.4 %) or constipation (90.8 %).
Conclusion: Low volume PEG-based preparations administered in a split-dose regimen guarantee noninferior bowel cleansing compared with 4 L PEG. Constipated patients require a personalized preparation.
Trial Registration: EudraCT 2012 - 003958 - 82.
(© Georg Thieme Verlag KG Stuttgart · New York.)
Patients and Methods: A total of 3660 patients with a positive FIT result were randomized to receive, in a split-dose regimen, 4 L PEG or 2 L PEG plus ascorbate (PEG-A) or 2 L PEG with citrate and simethicone plus bisacodyl (PEG-CS). The noninferiority of the low volume preparations vs. 4 L PEG was tested through the difference in proportions of adequate cleansing.
Results: A total of 2802 patients were included in the study. Adequate bowel cleansing was achieved in 868 of 926 cases (93.7 %) in the 4 L PEG group, in 872 out of 911 cases in the PEG-A group (95.7 %, difference in proportions + 1.9 %, 95 % confidence interval [CI] - 0.1 to 3.9), and in 862 out of 921 cases in the PEG-CS group (93.6 %, difference in proportions - 0.2 %, 95 %CI - 2.4 to 2.0). Bowel cleansing was adequate in 95.5 % of cases when the preparation-to-colonoscopy interval was between 120 and 239 minutes, whereas it dropped to 83.3 % with longer intervals. Better cleansing was observed in patients with regular bowel movements (95.6 %) compared with those with diarrhea (92.4 %) or constipation (90.8 %).
Conclusion: Low volume PEG-based preparations administered in a split-dose regimen guarantee noninferior bowel cleansing compared with 4 L PEG. Constipated patients require a personalized preparation.
Trial Registration: EudraCT 2012 - 003958 - 82.
(© Georg Thieme Verlag KG Stuttgart · New York.)