Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for colonoscopy (Clensia): a multicenter randomized observer-blind clinical trial vs. a low-volume PEG with ascorbic acid (PEG-ASC)

Abstract

Background and study aims Quality of inspection during colonoscopy is strictly related to the level of cleansing. High-volume (PEG-based) solutions are highly effective and safe, but their high volume affects tolerability and compliance. The 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).

Patients and methods This was a multicenter, randomized, observer-blind, parallel-group, phase 3 clinical trial, where 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 am to 12 pm, or to take a split regimen if colonoscopy was scheduled after 11 am to 12 pm. The 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, 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 183 in the PEG-ASC group. Successful bowel cleansing was 78.3 % and 74.3 % in PMF104 and in PEG-ASC, respectively (P = 0.37). Both preparations were equally safe (mild adverse events were observed in 9.2 % and 9.3 % of patients in the PMF104 and in the PEG-ASC group, respectively) and acceptable (no or mild distress during the intake in 81.4 % and 80.8 % in the PMF104 in the PEG-ASC, respectively [P = 0.74]).

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

• References

• 1 Lee TJ, Nair S, Beintaris I. et al. Recent advances in colonoscopy. F1000Res 2016; 11;5: 328
• 2 Rex DK, Johnson DA, Anderson JC. et al. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol 2009; 104: 739-750
• 3 von Karsa L, Patnick J, Segnan N. et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy 2013; 45: 51-59
• 4 Rex DK, Schoenfeld PS, Cohen J. et al. Quality indicators for colonoscopy. Gastrointest Endosc 2015; 81: 31-53
• 5 Kaminski MF, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2017; 49: 378-397
• 6 Clark BT, Protiva P, Nagar A. et al. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology 2016; 150: 396-405; quiz e14-15
• 7 Radaelli F, Paggi S, Hassan C. et al. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut 2017; 66: 270-277
• 8 Hassan C, Bretthauer M, Kaminski MF. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 142-150
• 9 Johnson DA, Barkun AN, Cohen LB. et al. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology 2014; 147: 903-924
• 10 Bucci C, Rotondano G, Hassan C. et al. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. . Gastrointest Endosc 2014; 80: 566-576
• 11 Zorzi M, Valiante F, Germanà B. et al. Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy. Endoscopy 2016; 48: 223-231
• 12 Martel M, Barkun AN, Menard C. et al. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology 2015; 149: 79-88
• 13 Xie Q, Chen L, Zhao F. et al. A meta-analysis of randomized controlled trials of low-volume polyethylene glycol plus ascorbic acid versus standard-volume polyethylene glycol solution as bowel preparations for colonoscopy. PloS One 2014; 9: e99092
• 14 Spada C, Cesaro P, Bazzoli F. et al. Evaluation of Clensia^®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG. Dig Liver Dis 2017; 49: 651-656
• 15 Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc 2004; 59: 482-486
• 16 Rex DK, Ahnen DJ, Baron JA. et al. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol 2012; 107: 1315-1329; quiz 1314-1330