A New, Rapid, Effective, Tolerable, and Safe Preparation Suitable for Colonoscopy at Any Time of the Day: A Multicenter Study

Abstract

Purpose: Background: The interval between bowel preparation and colonoscopy determines the quality of cleansing. A split-dose regimen is more effective than taking the entire dose the day before colonoscopy. A morning-only preparation is effective and more convenient, but usually used only for afternoon colonoscopy. A reduced-volume polyethylene glycol and electrolyte solution (PEG-ELS) plus ascorbic acid (Asc) may require less time for preparation and allow a morning procedure. Objective: To assess the efficacy and time requirements of two different regimens for morning-only preparation for colonoscopy. Methods: Design: Randomized trial with central allocation and masking of investigators to group assignment. Setting: Twelve endoscopy centers in Japan. Participants: 444 adults aged 20 or older requiring colonoscopy for various clinical indications. Intervention: A standard PEG-ELS (group A) or reduced-volume PEG-ELS + Asc (similar formulation available as MOVIPREP® - Norgine) with additional water (group B) was ingested on the morning of the colonoscopy. No dietary restrictions were applied until the evening before examination. Laxatives and prokinetics were prohibited. Measurements: Quality of colon cleansing was evaluated independently by 3 investigators masked to group allocation reviewing multiple photographs. Time interval between the initiation and completion of preparation was recorded. Adverse events were assessed by clinical and laboratory indicators. Results: 437 participants (A 219, B 218) completed the preparation. Quality of cleansing was adequate (excellent or satisfactory) in both groups and comparable (A 96.8% vs. B 98.6%; NS). Significantly less time was required to complete the preparation in group B (A 3.183±0.987 vs. B 2.659±0.829 hours; p<0.0001). Most adverse events were minor, but events precluding complete preparation were observed in 7 (A 6 vs. B 1). One patient in group A developed a transient ileus, and nausea and/or vomiting occurred in the other 6. Limitations: All participants were Japanese. Applicability of the study result to a western population has not been tested. Conclusion: Morning-only preparation using a PEG-ELS + Asc solution is as effective, and seems to be safer and more tolerable than using standard PEG-ELS. In addition, it requires significantly less time, allowing the procedure to be conducted at any time of day. Disclosure: All authors are Advisory Committee/Board Members: Ajinomoto Pharmaceuticals Co. Ltd., Tokyo, Japan. This research was supported by an industry grant from Ajinomoto Pharmaceuticals Co. Ltd., Tokyo, Japan.