145 Effectiveness and Tolerability of Very Low-Volume Preparation for Colonoscopy: A Prospective, Multicenter Observational Study

Abstract

INTRODUCTION: The effectiveness of bowel cleansing is essential for a quality colonoscopy since it affects diagnostic accuracy and adenoma detection rate. This study aimed to assess the effectiveness and tolerability of NER1006, a novel 1L PEG preparation, compared to 4 and 2 L PEG solutions in a real-life setting. METHODS: All in- and out-patients scheduled for a screening, surveillance or diagnostic colonoscopy, after an afternoon only or afternoon/morning 1, 2 or 4L PEG-based preparation were consecutively enrolled from September 2018 to February 2019 in 5 Italian centres. Bowel cleansing was assessed through the Boston Bowel Preparation Scale (BBPS), a bowel cleansing success was defined as a total BBPS ≥6 with a partial BBPS ≥2 in each segment and a high-quality cleansing of the right colon as a partial BBPS = 3. Tolerability was evaluated through a semi-quantitative scale with a score ranging from 1 to 10. RESULTS: 1289 patients meeting inclusion criteria were enrolled in the study. Of these, 490 performed a 4L PEG preparation, 566 a 2L PEG cleansing and 233 a 1L PEG preparation. Overall, bowel cleansing by BBPS was 6.3 ± 1.5, 6.2 ± 1.5 and 7.3 ± 1.5 (P < 0.001) for 4L, 2L and 1L PEG preparation respectively. Cleansing success was achieved in 72.4%, 74.5% and 90.1% (P < 0.001), while high-quality cleansing of the right colon in 15.5%, 11.7% and 39.5% (P < 0.001) for 4L, 2L and 1L PEG preparation groups, respectively. The 1L preparation was the most tolerated compared to the 2 and 4L PEG solutions, with an average score of 7.8 ± 1.7 vs 7.1 ± 2.0 and 7.3 ± 2.0 (P < 0.001) respectively, in the absence of serious adverse events. At multivariate analysis, age (OR = 0.98, 95% CI = 0.97–0.99; P = 0.02), absence of diabetes (OR = 1.51, 95% CI = 1.01–2.25; P = 0.04), adequate cleansing at previous colonoscopy (OR = 2.37, 95% CI = 1.37–4.09; P = 0.002), afternoon-morning split regimen (OR = 2.52, 95% CI = 1.65–3.83; P < 0.001), low-fiber diet for at least 3 days preceding colonoscopy (OR = 2.31, 95% CI = 1.61–3.31; P < 0.001), colonoscopy within 5 hours after the end of preparation (OR = 2.16, 95% CI = 1.30–3.60; P = 0.003) and tolerability score (OR = 1.22, 95% CI = 1.14–1.31; P < 0.001) were independently associated with bowel cleansing success. CONCLUSION: The novel 1L PEG-ASC solution (NER1006) presents greater effectiveness compared to higher-volume PEG preparation in terms of overall bowel cleansing and high-quality cleansing of the right colon with the advantage of better tolerability respect to comparators.

Colonoscopia de calidad, limpieza y preparación colónica

“…En estudios aleatorizados controlados fase 3 9,10 la preparación de muy bajo volumen NER1006 (1L PEG + ácido ascórbico) vs. 2L y 4L reportó que 1L fue la más efectiva y con mejor apego y tolerancia en comparación con 2L y 4L 9 ; NER1006 también demostró seguridad en pacientes con falla renal leve a moderada 10 .…”