Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy

Manuel Zorzi; Flavio Valiante; Bastianello Germanà; Gianluca Baldassarre; Bartolomea Coria; Michela Rinaldi; Helena Heras Salvat; Alessandra Carta; Francesco Bortoluzzi; Erica Cervellin; Maria Luisa Polo; Gianmarco Bulighin; Maurizio Azzurro; Daniele Di Piramo; Anna Turrin; Fabio Monica; the TriVeP Working Group

doi:10.1055/s-0035-1569574

Endoscopy, Table of Contents

Endoscopy 2016; 48(03): 223-231
DOI: 10.1055/s-0035-1569574

Original article

Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy

Manuel Zorzi

¹Veneto Cancer Registry, Regione Veneto, Padua, Italy

,

Flavio Valiante

²Gastroenterologia ed endoscopia digestiva, ULSS 2, Feltre, Italy

,

Bastianello Germanà

³Dipartimento delle Chirurgie Specialistiche, Gastroenterologia, Ospedale S. Martino, ULSS 1, Belluno, Italy

,

Gianluca Baldassarre

⁴Endoscopia Digestiva, Ospedale Alto Vicentino, ULSS 4, Santorso, Italy

,

Bartolomea Coria

⁵Centrale Operativa Screening, Servizio Igiene e Sanità Pubblica, ULSS 6, Vicenza, Italy

,

Michela Rinaldi

⁶Gastroenterologia, Ospedale di Conegliano, ULSS 7, Conegliano, Italy

,

Helena Heras Salvat

⁷Gastroenterologia, Ospedale S. Maria di Ca’ Foncello, ULSS 9, Treviso, Italy

,

Alessandra Carta

⁸Endoscopia Digestiva, Chirurgia, ULSS 10, San Donà di Piave, Italy

,

Francesco Bortoluzzi

⁹Gastroenterologia, ULSS 12, Venezia, Italy

,

Erica Cervellin

¹⁰Gastroenterologia, Ospedale di Dolo, ULSS 13, Dolo, Italy

,

Maria Luisa Polo

¹¹Centrale Operativa Screening, ULSS 14, Chioggia, Italy

,

Gianmarco Bulighin

¹²Gastroenterologia ed Endoscopia Digestiva, ULSS 20, San Bonifacio, Italy

,

Maurizio Azzurro

¹³Endoscopia Digestiva e Gastroenterologia, ULSS 21, Legnago, Italy

,

Daniele Di Piramo

¹⁴Gastroenterologia ed Endoscopia Digestiva, ULSS 22, Bussolengo, Italy

,

Anna Turrin

¹⁵Settore promozione e sviluppo igiene e sanità pubblica, Regione Veneto, Venezia, Italy

,

Fabio Monica

¹⁶Gastroenterologia ed Endoscopia, Azienda Ospedaliero Universitaria “Ospedali Riuniti,” Trieste, Italy

,

the TriVeP Working Group

› Author Affiliations

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.

Full Text

References

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Supplementary Material

Supplementary material