Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG

被引：37

作者：

Spada, Cristiano ^{[1
]}

Cesaro, Paola ^{[1
]}

Bazzoli, Franco ^{[2
]}

Saracco, Giorgio Maria ^{[3
]}

Cipolletta, Livio ^{[4
,5
]}

Buri, Luigi ^{[6
]}

Crosta, Cristiano ^{[7
]}

Petruzziello, Lucio ^{[1
]}

Ceroni, Liza ^{[2
]}

Fuccio, Lorenzo ^{[2
]}

Giordanino, Chiara ^{[3
]}

Elia, Chiara ^{[3
]}

Rotondano, Gianluca ^{[4
,5
]}

Bianco, Maria A. ^{[4
,5
]}

Simeth, Catrin ^{[6
]}

Consalvo, Danilo ^{[3
]}

De Roberto, Giuseppe ^{[7
]}

Fiori, Giancarla ^{[7
]}

Campanale, Mariachiara ^{[1
]}

Costamagna, Guido ^{[1
,8
]}

机构：

[1] Catholic Univ, Digest Endoscopy Unit, Rome, Italy

[2] Univ Bologna, DIMEC Dept Med & Surg Sci, Gastroenterol Unit, Bologna, Italy

[3] Univ Turin, Dept Gastroenterol, Molinette Hosp Molinette, Turin, Italy

[4] Hosp A Maresca, Div Gastroenterol, Torre Del Greco, Italy

[5] Hosp A Maresca, Digest Endoscopy Unit, Torre Del Greco, Italy

[6] Cattinara Hosp, Gastroenterol & Digest Endoscopy Unit, Trieste, Italy

[7] European Inst Oncol, Endoscopy Div, Milan, Italy

[8] IHU, Strasbourg, France

来源：

DIGESTIVE AND LIVER DISEASE | 2017年 / 49卷 / 06期

关键词：

Bowel preparation; Citrates; Colonoscopy; Polyethylene glycol; Randomised clinical trial; Simeticone; DOSE POLYETHYLENE-GLYCOL; SOCIETY-TASK-FORCE; COLORECTAL-CANCER; SODIUM-PHOSPHATE; SCREENING COLONOSCOPY; IMPROVING VISIBILITY; PREPARATION QUALITY; CLEANSING PRIOR; PLUS BISACODYL; CLINICAL-TRIAL;

D O I：

10.1016/j.dld.2017.01.167

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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. (C) 2017 The Authors. Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.

引用

页码：651 / 656

页数：6

共 30 条

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