Routine GI Endoscopy

Abstract

Background and Aim: Post-marketing studies comparing low-volume polyethylene glycol (PEG)-based regimens are limited. The aim of this randomized controlled non-inferiority study was to compare the efficacy and tolerability of two commercially available low-volume PEG-based preparations: PLENVU (Norgine) macrogol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride and Prepkit-C (Fresenius Kabi) macrogol 3350, sodium chloride, potassium chloride and sodium sulfate, sodium picosulfate, magnesium oxide, citric acid and aspartame in an unselected adult colonoscopy outpatient population. Methods: Patients undergoing outpatient colonoscopy were randomized to receive either split-dose Prepkit-C or PLENVU. Patient compliance, satisfaction, and tolerability were captured using a standardized questionnaire on the day of the procedure. A blinded endoscopist assessed the quality of bowel preparation using the Boston Bowel Preparation Scale (BBPS) and Aronchick Scale during the colonoscopy. The procedure times, rates of cecal intubation, and polyp detection rates were also recorded. Results: The study was terminated at 19 months, as recruitment was halted due to the coronavirus disease 2019 pandemic, and an unplanned interim analysis was performed. A total of 164 patients were randomly assigned to either Prepkit-C (n = 82) or PLENVU (n = 82). In the PLENVU group, 89% of patients achieved satisfactory preparation (total BPPS score ≥6 and each subscore ≥2), compared with 85.4% in the Prepkit-C group, resulting in an estimated difference of 3.7% (95% CI, -6.6% to 13.9%;P = 0.48). The median BBPS score with PLENVU was significantly better in the right, middle, and left colonic subsegments with PLENVU (BBPS score, 3;IQR, 2-3) than with Prepkit-C (BBPS score, 2;IQR, 2-3) (P < 0.001). A significantly higher proportion of patients in the PLENVU group had a BBPS score of ≥7, compared with patients in the Prepkit-C group (80% vs 57%;P = 0.002). A significantly greater proportion of patients had good-excellent quality of bowel preparation in the PLENVU group compared with the Prepkit-C group (84% vs 57%;P < 0.001) (Fig. 1). More patients in the PLENVU group reported moderate to severe nausea compared with those in the Prepkit-C group (P = 0.028);however, there were no other differences in patient satisfaction or tolerability between the two groups. Conclusion: The quality of bowel preparation achieved with PLENVU is at least non-inferior to that with Prepkit-C in a real-world unselected group of colonoscopy outpatients, with equivalent tolerability outcomes. This is despite a lower volume of preparation (by 500 mL) that is required to be ingested with PLENVU. Further studies are required in patients at risk of suboptimal bowel preparation.