Endoscopy 2016; 48(03): 223-231
DOI: 10.1055/s-0035-1569574
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Manuel Zorzi
1  Veneto Cancer Registry, Regione Veneto, Padua, Italy
Flavio Valiante
2  Gastroenterologia ed endoscopia digestiva, ULSS 2, Feltre, Italy
Bastianello Germanà
3  Dipartimento delle Chirurgie Specialistiche, Gastroenterologia, Ospedale S. Martino, ULSS 1, Belluno, Italy
Gianluca Baldassarre
4  Endoscopia Digestiva, Ospedale Alto Vicentino, ULSS 4, Santorso, Italy
Bartolomea Coria
5  Centrale Operativa Screening, Servizio Igiene e Sanità Pubblica, ULSS 6, Vicenza, Italy
Michela Rinaldi
6  Gastroenterologia, Ospedale di Conegliano, ULSS 7, Conegliano, Italy
Helena Heras Salvat
7  Gastroenterologia, Ospedale S. Maria di Ca’ Foncello, ULSS 9, Treviso, Italy
Alessandra Carta
8  Endoscopia Digestiva, Chirurgia, ULSS 10, San Donà di Piave, Italy
Francesco Bortoluzzi
9  Gastroenterologia, ULSS 12, Venezia, Italy
Erica Cervellin
10  Gastroenterologia, Ospedale di Dolo, ULSS 13, Dolo, Italy
Maria Luisa Polo
11  Centrale Operativa Screening, ULSS 14, Chioggia, Italy
Gianmarco Bulighin
12  Gastroenterologia ed Endoscopia Digestiva, ULSS 20, San Bonifacio, Italy
Maurizio Azzurro
13  Endoscopia Digestiva e Gastroenterologia, ULSS 21, Legnago, Italy
Daniele Di Piramo
14  Gastroenterologia ed Endoscopia Digestiva, ULSS 22, Bussolengo, Italy
Anna Turrin
15  Settore promozione e sviluppo igiene e sanità pubblica, Regione Veneto, Venezia, Italy
Fabio Monica
16  Gastroenterologia ed Endoscopia, Azienda Ospedaliero Universitaria “Ospedali Riuniti,” Trieste, Italy
the TriVeP Working Group› Author Affiliations
Further Information

Publication History

submitted: 01 April 2015

accepted after revision: 13 October 2015

Publication Date:
13 January 2016 (online)

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.

Fig. e3, Appendix e1, e2