Endoscopy 2018; 50(04): S87
DOI: 10.1055/s-0038-1637286
ESGE Days 2018 oral presentations
21.04.2018 – Colon cleansing
Georg Thieme Verlag KG Stuttgart · New York

HIGHER HAREFIELD CLEANSING SCALE SCORES ARE ASSOCIATED WITH IMPROVED LESION DETECTION: POST HOC ANALYSIS OF THREE RANDOMISED AND CENTRAL READER-ASSESSED PHASE 3 CLINICAL TRIALS

J Manning
1   Borders General Hospital, Melrose, Berwickshire, United Kingdom
,
C Hassan
2   Nuovo Regina Margherita Hospital, Gastroenterology and Endoscopic, Rome, Italy
,
J Halonen
3   Norgine, Medical Affairs, Harefield, United Kingdom
,
B Amlani
3   Norgine, Medical Affairs, Harefield, United Kingdom
,
M Epstein
4   Investigative Clinical Research, Annapolis, Maryland, United States
› Author Affiliations
Further Information

Publication History

Publication Date:
27 March 2018 (online)

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Aims:

Effective colonoscopy requires successful bowel cleansing. The bowel preparation NER1006 (PLENVU®) was assessed in three identically designed randomised phase 3 clinical trials. These trials used validated cleansing scales and treatment-blinded central readers for a standardised cleansing quality assessment. This post hoc analysis assessed the relationship between colon cleansing quality using the Harefield Cleansing Scale (HCS), and overall colon detection rates for adenomas (ADR) and polyps (PDR).

Methods:

Patients aged 18 – 85 years were included if they had fully reported HCS scores, adenoma and polyp counts, and also identical segmental HCS scores (range 0 – 4) in all five HCS colon segments. A logistic regression analysis examined the odds ratio (OR), 95% confidence interval (CI) and P-value (P) for the resulting trend in lesion detection, when segmental HCS scores increased incrementally from zero to four.

Results:

469 patients were included in this analysis (Table 1). When uniform segmental HCS scores were increased from 0, 1, 2, 3, and 4, the resulting ADRs increased continuously (0%, 10.0%, 25.6%, 32.4% and 53.8%) as did the PDRs (0%, 30%, 43.3%, 51.4%, and 61.5%). The corresponding OR (CI) and [P] were, for ADR 1.61 (1.182 – 2.199) [0.0026], and for PDR 1.38 (1.021 – 1.863) [0.0361].

Tab. 1:

Uniform HCS scores vs. lesion detection

0/0/0/0/0 N = 4

1/1/1/1/1 N = 10

2/2/2/2/2 N = 379

3/3/3/3/3 N = 37

4/4/4/4/4 N = 39

ADR, n (%)

0

1 (10.0)

97 (25.6)

12 (32.4)

21 (53.8)

PDR, n (%)

0

3 (30.0)

164 (43.3)

19 (51.4)

24 (61.5)

Logistic regression analysis of the trend for uniform HCS scores vs. ADR: Odds ratio (95% CI) [P-value]

1.61 (1.182 – 2.199) [0.0026]

Logistic regression analysis of the trend for uniform HCS scores vs. PDR: Odds ratio (95% CI) [P-value]

1.38 (1.021 – 1.863) [0.0361]

Conclusions:

ADR and PDR increased continuously with improved colon cleansing quality. There was a strong association between uniform segmental HCS scores and both ADR and PDR.