Endoscopy 2018; 50(04): S89-S90
DOI: 10.1055/s-0038-1637294
ESGE Days 2018 oral presentations
21.04.2018 – Colon cleansing
Georg Thieme Verlag KG Stuttgart · New York

EFFICACY AND SAFETY OF A NEW LOW-VOLUME PEG BOWEL PREPARATION FOR COLONOSCOPY (CLENSIA®): A MULTICENTER RANDOMIZED TRIAL VS LOW VOLUME PEG WITH ASCORBIC ACID (PEG-ASC)

P Kump
1   Medical University Graz, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Graz, Austria
,
C Hassan
2   Nuovo Regina Margherita Hospital, Gastroenterology Department, Rome, Italy
,
C Spada
3   Fondazione Poliambulanza, Digestive Endoscopy Unit, Brescia, Italy
,
E Brownstone
4   KH Rudolfstiftung, Internal Medicine IV, Vienna, Austria
,
C Datz
5   Oberndorf Hospital, Teaching Hospital of the Paracelsus Medical University, Department of Internal Medicine, Salzburg, Austria
,
M Haefner
6   Medical University of Vienna, Department of Gastroenterology and Hepatology, Vienna, Austria
,
F Renner
7   Krankenhaus der Barmherzigen Schwestern, Interne Abteilung, Ried, Austria
,
R Schoefl
8   KH der Elisabethinen, Internal Medicine IV, Linz, Austria
,
F Schreiber
1   Medical University Graz, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Graz, Austria
› Author Affiliations
Further Information

Publication History

Publication Date:
27 March 2018 (online)

Also available at
 

Aims:

Quality of inspection during colonoscopy is strictly related to the level of cleansing. High-volume solutions are highly effective and safe, but high volume affects tolerability and compliance. Aim of this study was to compare a new low volume PEG with citrate and simethicone solution (PMF 104, Clensia®) with a low volume PEG with ascorbic acid solution (PEG-ASC; Moviprep®).

Methods:

This is a multicenter, randomized, observer-blind, parallel-group, phase-3 clinical trial. Patients were randomized between PMF 104 and PEG-ASC. In both groups, patients were instructed to take a full dose regimen the evening before if colonoscopy was scheduled before 11 – 12 am, or to take a split regimen if colonoscopy was scheduled after 11 – 12 am. Primary end-point was an equivalence between PMF104 and PEG-ASC in the rate of adequate level of cleansing (Ottawa scale ≤6), with safety, mucosal visibility, tolerability, acceptance and compliance being also assessed.

Results:

Of the 403 enrolled patients 367 patients (Mean age (SD): 55.6 (14.4) years; male: 166 (45.2%)) were included in the per protocol (PP) analysis: 184 being randomized in the PMF 104 group and the remaining 183 in the PEG-ASC. Overall, rate of successful bowel cleansing was 78.3% in PMF104 and 74.3% in PEG-ASC (p = 0.37). Successful bowel cleansing was higher with split dose regimen (86.2% for PMF 104 and 78.7% for PEG-ASC) as compared with full dose regimen (75% for PMF104 and 72.5% for PEG-ASC). Both the preparations were equally safe (9.2% of patients in the PMF104 and 9.3% of patients in the PEG-ASC groups experienced mild adverse events) and acceptable (patients reported no or mild distress during the intake in 81.4% in the PMF104 and 80.8% in the PEG-ASC, p = 0.74).

Conclusions:

The new low volume product Clensia® is equivalent to the reference low volume PEG-ASC in terms of bowel cleansing, safety and acceptance.