Comparable quality of bowel preparation with single-day versus three-day low-residue diet: Randomized controlled trial

Abstract

Background and Aims: There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy. Methods: A non-inferiority, randomized, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level. Results: A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (P-value for non-inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1-day LRD group (254 vs 221 in the 3-day LRD group, P = 0.032). The 1-day regimen was better tolerated than the 3-day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1-day LRD as very easy to follow. Conclusion: The 1-day LRD is non-inferior to 3-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.