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

Research output: Contribution to journalArticle

Abstract

Background Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4 L (PEG 4 L) 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 4 L. Methods In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2 L or PEG 4 L 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 4 L (n = 209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4 L group respectively. Clensia was demonstrated to be equivalent to PEG 4 L. 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 4 L 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 4 L, P = 0.9388). Conclusions The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4 L, with better gastrointestinal tolerability and acceptability.

Original languageEnglish
Pages (from-to)651-656
Number of pages6
JournalDigestive and Liver Disease
Volume49
Issue number6
DOIs
Publication statusPublished - Jun 1 2017

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Keywords

  • Bowel preparation
  • Citrates
  • Colonoscopy
  • Polyethylene glycol
  • Randomised clinical trial
  • Simeticone

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Spada, C., Cesaro, P., Bazzoli, F., Saracco, G. M., Cipolletta, L., Buri, L., Crosta, C., Petruzziello, L., Ceroni, L., Fuccio, L., Giordanino, C., Elia, C., Rotondano, G., Bianco, M. A., Simeth, C., Consalvo, D., De Roberto, G., Fiori, G., Campanale, M., & Costamagna, G. (2017). Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG. Digestive and Liver Disease, 49(6), 651-656. https://doi.org/10.1016/j.dld.2017.01.167