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

5 Citations (Scopus)

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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Colonoscopy
Randomized Controlled Trials
Citrates
Compliance
Colon

Keywords

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

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy : Multicentre randomized controlled trial versus 4L PEG. / Spada, Cristiano; Cesaro, Paola; Bazzoli, Franco; Saracco, Giorgio Maria; Cipolletta, Livio; Buri, Luigi; Crosta, Cristiano; Petruzziello, Lucio; Ceroni, Liza; Fuccio, Lorenzo; Giordanino, Chiara; Elia, Chiara; Rotondano, Gianluca; Bianco, Maria A.; Simeth, Catrin; Consalvo, Danilo; De Roberto, Giuseppe; Fiori, Giancarla; Campanale, Mariachiara; Costamagna, Guido.

In: Digestive and Liver Disease, Vol. 49, No. 6, 01.06.2017, p. 651-656.

Research output: Contribution to journalArticle

Spada, C, Cesaro, P, Bazzoli, F, Saracco, GM, Cipolletta, L, Buri, L, Crosta, C, Petruzziello, L, Ceroni, L, Fuccio, L, Giordanino, C, Elia, C, Rotondano, G, Bianco, MA, 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, vol. 49, no. 6, pp. 651-656. https://doi.org/10.1016/j.dld.2017.01.167
Spada, Cristiano ; Cesaro, Paola ; Bazzoli, Franco ; Saracco, Giorgio Maria ; Cipolletta, Livio ; Buri, Luigi ; Crosta, Cristiano ; Petruzziello, Lucio ; Ceroni, Liza ; Fuccio, Lorenzo ; Giordanino, Chiara ; Elia, Chiara ; Rotondano, Gianluca ; Bianco, Maria A. ; Simeth, Catrin ; Consalvo, Danilo ; De Roberto, Giuseppe ; Fiori, Giancarla ; Campanale, Mariachiara ; Costamagna, Guido. / Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy : Multicentre randomized controlled trial versus 4L PEG. In: Digestive and Liver Disease. 2017 ; Vol. 49, No. 6. pp. 651-656.
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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.",
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T1 - Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy

T2 - Multicentre randomized controlled trial versus 4L PEG

AU - Spada, Cristiano

AU - Cesaro, Paola

AU - Bazzoli, Franco

AU - Saracco, Giorgio Maria

AU - Cipolletta, Livio

AU - Buri, Luigi

AU - Crosta, Cristiano

AU - Petruzziello, Lucio

AU - Ceroni, Liza

AU - Fuccio, Lorenzo

AU - Giordanino, Chiara

AU - Elia, Chiara

AU - Rotondano, Gianluca

AU - Bianco, Maria A.

AU - Simeth, Catrin

AU - Consalvo, Danilo

AU - De Roberto, Giuseppe

AU - Fiori, Giancarla

AU - Campanale, Mariachiara

AU - Costamagna, Guido

PY - 2017/6/1

Y1 - 2017/6/1

N2 - 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.

AB - 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.

KW - Bowel preparation

KW - Citrates

KW - Colonoscopy

KW - Polyethylene glycol

KW - Randomised clinical trial

KW - Simeticone

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