title: Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy.
abstract: OBJECTIVE
  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.
  
  
  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 %).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EudraCT 2012 - 003958 - 82.
authors.affiliation: Veneto Cancer Registry, Regione Veneto, Padua, Italy.
authors.forename: Manuel
authors.initials: M
authors.lastname: Zorzi
authors.affiliation: Gastroenterologia ed endoscopia digestiva, ULSS 2, Feltre, Italy.
authors.forename: Flavio
authors.initials: F
authors.lastname: Valiante
authors.affiliation: Dipartimento delle Chirurgie Specialistiche, Gastroenterologia, Ospedale S. Martino, ULSS 1, Belluno, Italy.
authors.forename: Bastianello
authors.initials: B
authors.lastname: Germanà
authors.affiliation: Endoscopia Digestiva, Ospedale Alto Vicentino, ULSS 4, Santorso, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Baldassarre
authors.affiliation: Centrale Operativa Screening, Servizio Igiene e Sanità Pubblica, ULSS 6, Vicenza, Italy.
authors.forename: Bartolomea
authors.initials: B
authors.lastname: Coria
authors.affiliation: Gastroenterologia, Ospedale di Conegliano, ULSS 7, Conegliano, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Rinaldi
authors.affiliation: Gastroenterologia, Ospedale S. Maria di Ca' Foncello, ULSS 9, Treviso, Italy.
authors.forename: Helena
authors.initials: H
authors.lastname: Heras Salvat
authors.affiliation: Endoscopia Digestiva, Chirurgia, ULSS 10, San Donà di Piave, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Carta
authors.affiliation: Gastroenterologia, ULSS 12, Venezia, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bortoluzzi
authors.affiliation: Gastroenterologia, Ospedale di Dolo, ULSS 13, Dolo, Italy.
authors.forename: Erica
authors.initials: E
authors.lastname: Cervellin
authors.affiliation: Centrale Operativa Screening, ULSS 14, Chioggia, Italy.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Polo
authors.affiliation: Gastroenterologia ed Endoscopia Digestiva, ULSS 20, San Bonifacio, Italy.
authors.forename: Gianmarco
authors.initials: G
authors.lastname: Bulighin
authors.affiliation: Endoscopia Digestiva e Gastroenterologia, ULSS 21, Legnago, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Azzurro
authors.affiliation: Gastroenterologia ed Endoscopia Digestiva, ULSS 22, Bussolengo, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Di Piramo
authors.affiliation: Settore promozione e sviluppo igiene e sanità pubblica, Regione Veneto, Venezia, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Turrin
authors.affiliation: Gastroenterologia ed Endoscopia, Azienda Ospedaliero Universitaria "Ospedali Riuniti," Trieste, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Monica
mesh_terms: D000328:Adult; D000368:Aged; D001205:Ascorbic Acid / Q000008:administration & dosage; D001726:Bisacodyl / Q000008:administration & dosage; D002400:Cathartics / Q000008:administration & dosage*; D019343:Citric Acid / Q000008:administration & dosage; D003113:Colonoscopy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012841:Simethicone / Q000008:administration & dosage
chemical_list: D002400:Cathartics; D001726:Bisacodyl; D019343:Citric Acid; D011092:Polyethylene Glycols; D012841:Simethicone; D001205:Ascorbic Acid