title: Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG.
abstract: BACKGROUND
  Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability.
  
  
  OBJECTIVE
  To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L.
  
  
  METHODS
  In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good.
  
  
  RESULTS
  422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388).
  
  
  CONCLUSIONS
  The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability.
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy. Electronic address: cristianospada@gmail.com.
authors.forename: Cristiano
authors.initials: C
authors.lastname: Spada
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cesaro
authors.affiliation: DIMEC Department of Medical and Surgical Sciences, Gastroenterology Unit, University of Bologna, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Bazzoli
authors.affiliation: Department of Gastroenterology, Molinette Hospital (Molinette), University of Turin, Italy.
authors.forename: Giorgio Maria
authors.initials: GM
authors.lastname: Saracco
authors.affiliation: Division of Gastroenterology and Digestive Endoscopy Unit, Hospital "A. Maresca", Torre del Greco, Italy.
authors.forename: Livio
authors.initials: L
authors.lastname: Cipolletta
authors.affiliation: Gastroenterology and Digestive Endoscopy Unit, Cattinara Hospital, Trieste, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Buri
authors.affiliation: Endoscopy Division, European Institute of Oncology, Milan, Italy.
authors.forename: Cristiano
authors.initials: C
authors.lastname: Crosta
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Lucio
authors.initials: L
authors.lastname: Petruzziello
authors.affiliation: DIMEC Department of Medical and Surgical Sciences, Gastroenterology Unit, University of Bologna, Italy.
authors.forename: Liza
authors.initials: L
authors.lastname: Ceroni
authors.affiliation: DIMEC Department of Medical and Surgical Sciences, Gastroenterology Unit, University of Bologna, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Fuccio
authors.affiliation: Department of Gastroenterology, Molinette Hospital (Molinette), University of Turin, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Giordanino
authors.affiliation: Department of Gastroenterology, Molinette Hospital (Molinette), University of Turin, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Elia
authors.affiliation: Division of Gastroenterology and Digestive Endoscopy Unit, Hospital "A. Maresca", Torre del Greco, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Rotondano
authors.affiliation: Division of Gastroenterology and Digestive Endoscopy Unit, Hospital "A. Maresca", Torre del Greco, Italy.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Bianco
authors.affiliation: Gastroenterology and Digestive Endoscopy Unit, Cattinara Hospital, Trieste, Italy.
authors.forename: Catrin
authors.initials: C
authors.lastname: Simeth
authors.affiliation: Gastroenterology and Digestive Endoscopy Unit, Cattinara Hospital, Trieste, Italy.
authors.forename: Danilo
authors.initials: D
authors.lastname: Consalvo
authors.affiliation: Endoscopy Division, European Institute of Oncology, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Roberto
authors.affiliation: Endoscopy Division, European Institute of Oncology, Milan, Italy.
authors.forename: Giancarla
authors.initials: G
authors.lastname: Fiori
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Mariachiara
authors.initials: M
authors.lastname: Campanale
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy; IHU, Strasbourg, USIAS, University of Strasbourg, France.
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D000368:Aged; D002400:Cathartics / Q000008:administration & dosage*; D002951:Citrates / Q000008:administration & dosage*; D003113:Colonoscopy; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011092:Polyethylene Glycols / Q000008:administration & dosage*
chemical_list: D002400:Cathartics; D002951:Citrates; D011092:Polyethylene Glycols
keywords: Bowel preparation; Citrates; Colonoscopy; Polyethylene glycol; Randomised clinical trial; Simeticone