Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG
Cristiano Spada, Paola Cesaro, Franco Bazzoli, Giorgio Maria Saracco, Livio Cipolletta, Luigi Buri, Cristiano Crosta, Lucio Petruzziello, Liza Ceroni, Lorenzo Fuccio, Chiara Giordanino, Chiara Elia, Gianluca Rotondano, Maria A Bianco, Catrin Simeth, Danilo Consalvo, Giuseppe De Roberto, Giancarla Fiori, Mariachiara Campanale, Guido Costamagna, Cristiano Spada, Paola Cesaro, Franco Bazzoli, Giorgio Maria Saracco, Livio Cipolletta, Luigi Buri, Cristiano Crosta, Lucio Petruzziello, Liza Ceroni, Lorenzo Fuccio, Chiara Giordanino, Chiara Elia, Gianluca Rotondano, Maria A Bianco, Catrin Simeth, Danilo Consalvo, Giuseppe De Roberto, Giancarla Fiori, Mariachiara Campanale, Guido Costamagna
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.
Aim: 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.
Keywords: Bowel preparation; Citrates; Colonoscopy; Polyethylene glycol; Randomised clinical trial; Simeticone.
Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed