Endoscopy 2019; 51(04): S71
DOI: 10.1055/s-0039-1681379
ESGE Days 2019 oral presentations
Friday, April 5, 2019 17:00 – 18:30: Colon cleansing 1 Club D
Georg Thieme Verlag KG Stuttgart · New York

EVALUATION OF A LOW VOLUME BOWEL CLEANSING PREPARATION (ORAL SULPHATE SOLUTION) VERSUS MACROGOL: A PHASE III, MULTICENTRE, RANDOMISED COMPARATIVE CLINICAL TRIAL

E Fedorov
1   Department of Operative Endoscopy, Moscow State Healthcare Institution Clinical Hospital No. 31 of Moscow City Health Department, Moscow, Russian Federation
,
S Kashin
2   State Healthcare Institution of Yaroslavl Region 'Regional Clinical Cancer Hospital', Yaroslavl, Russian Federation
,
V Veselov
3   Federal State Budgetary Institution 'State Scientifical Center of Coloproctology' at the Ministry of Health of Russian Federation, Moscow, Russian Federation
,
E Tikhomirova
4   Laboratory of Surgical Gastroenterology and Endoscopy NI Pirogov RNIMU, Moscow, Russian Federation
,
D Zavialov
2   State Healthcare Institution of Yaroslavl Region 'Regional Clinical Cancer Hospital', Yaroslavl, Russian Federation
,
A Veselov
3   Federal State Budgetary Institution 'State Scientifical Center of Coloproctology' at the Ministry of Health of Russian Federation, Moscow, Russian Federation
,
A Kornowski
5   Ipsen Pharma, Boulogne-Billancourt, France
,
T Gorskaya
6   Ipsen, Moscow, Russian Federation
,
M Volteau
7   Ipsen Pharma, Les Ulis, France
,
T Ponchon
8   Hôpital Edouard Herriot, Lyon, France
› Author Affiliations
Further Information

Publication History

Publication Date:
18 March 2019 (online)

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Aims:

This study aimed to demonstrate the non-inferiority of low-volume oral sulphate solution (OSS) to macrogol 4000+electrolytes for bowel preparation, and assess the efficacy, safety and acceptability of OSS.

Methods:

This prospective, randomised, investigator-blinded, parallel group, multicentre, non-inferiority phase III study (NCT02321462) was conducted at three centres in Russia between March and December 2015. Adults undergoing diagnostic colonoscopy were randomised to receive OSS or macrogol as a split dose. Anonymised videos of the examinations were centrally reviewed. The primary endpoint was the proportion of patients with successful overall bowel preparation, defined as Boston Bowel Preparation Scale (BBPS) global score ≥6. Secondary endpoints included patient compliance and safety.

Results:

296 patients were randomised (OSS: 147, macrogol: 149): 294 in the Intention-to-Treat (ITT) population, 274 in the Per-Protocol (PP) population. 22 OSS patients and 21 macrogel patients had inflammatory bowel disease (IBD). Bowel preparation success (BBPS ≥6) was high in both groups (OSS: 97.2% [95% CI: 89.5 – 99.3]; macrogol: 97.7% [95% CI: 90.7 – 99.4]; PP population). The adjusted difference between the groups was -0.5% (95% CI -4.2 – 3.3), demonstrating non-inferiority of OSS compared to macrogol (non-inferiority margin was -15%;). Compliance was higher in the OSS group than the macrogol group (95.7% vs. 82.3%, respectively, p = 0.0011; ITT population). Nausea was the most frequent adverse event (AE); more patients experienced nausea in the OSS group than in the macrogol group (25.2% vs. 10.2%, respectively [p = 0.0008], after the first dose). Differences between treatment groups in the frequency of other preparation-related AEs (vomiting, abdominal distension, abdominal pain, abdominal discomfort) were not significant. AE intensity was generally mild. The safety profile of patients with IBD not in active phase was similar to the overall population.

Conclusions:

This study demonstrated that split-dose OSS was non-inferior to macrogol. Despite a higher incidence of nausea in the OSS group, compliance was better with OSS.