Marcello Maida, MD1, Gaetano Morreale, MD1, Emanuele Sinagra, MD2, Sandro Sferrazza, MD3, Michele Manganaro, MD1, Giuseppe Scalisi, MD4, Dario Schillaci, MD5, Giovanni Vettori, MD3, Giuseppe Conoscenti, MD2, Concetta Di Bartolo, MD4, Serena Garufi, MD1, Clara Maria Virgilio, MD4, Salvatore Camilleri, MD1
1S. Elia-Raimondi Hospital, Caltanissetta, Sicilia, Italy; 2Fondazione Istituto San Raffaele Giglio, Cefalù, Sicilia, Italy; 3Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy; 4ARNAS Garibaldi, Catania, Sicilia, Italy; 5Basarocco Hospital, Niscemi, Sicilia, Italy
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 2L 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.
Discussion: 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.
Citation: Marcello Maida, MD; Gaetano Morreale, MD; Emanuele Sinagra, MD; Sandro Sferrazza, MD; Michele Manganaro, MD; Giuseppe Scalisi, MD; Dario Schillaci, MD; Giovanni Vettori, MD; Giuseppe Conoscenti, MD; Concetta Di Bartolo, MD; Serena Garufi, MD; Clara Maria Virgilio, MD; Salvatore Camilleri, MD. P0124 - EFFECTIVENESS AND TOLERABILITY OF VERY LOW-VOLUME PREPARATION FOR COLONOSCOPY: A PROSPECTIVE, MULTICENTER OBSERVATIONAL STUDY. Program No. P0124. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.