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