Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy

Abstract

Background: Elective colonoscopy is used increasingly to screen at risk patients for colonic malignancy. Bowel preparation quality is a critical factor for successful screening. Preparations used include high doses of potent laxatives, e.g. sodium phosphate solution or high volume polyethylene glycol. Because of constraints and limited patient acceptability, there remains a need for a more acceptable bowel preparation with at least equivalent cleansing to existing preparations.

Aim: To determine if a 2-L polyethylene glycol solution with electrolytes and ascorbic acid (polyethylene glycol + ascorbic acid) produces equivalent bowel cleansing to sodium phosphate solution, and is acceptable to patients and well tolerated.

Methods: This was a single blind, parallel group, equivalence study comparing polyethylene glycol + ascorbic acid with sodium phosphate solution in 352 patients undergoing elective colonoscopy. A blinded, independent expert scored a video recording of each colonoscopy. Patients completed a questionnaire reporting acceptability of the bowel preparation process.

Results: Clinically successful bowel preparation was reported in 72.5% of cases prepared using polyethylene glycol + ascorbic acid and in 63.9% of cases prepared using sodium phosphate solution (treatment difference +8.6%, 95% confidence interval -2.3%, +19.4%). The new solution was well accepted and better tolerated than sodium phosphate solution.

Conclusions: The new 2-L solution of polyethylene glycol + ascorbic acid was at least as efficacious as sodium phosphate solution with comparable efficacy and a better tolerability profile.