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Comparable quality of bowel preparation with single‐day versus three‐day low‐residue diet: Randomized controlled trial
Author(s) -
Machlab Salvador,
MartínezBauer Eva,
López Pilar,
Piqué Núria,
PuigDiví Valentí,
Junquera Félix,
Lira Alba,
Brullet Enric,
Selva Anna,
GarcíaIglesias Pilar,
Calvet Xavier,
Campo Rafel
Publication year - 2021
Publication title -
digestive endoscopy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.5
H-Index - 56
eISSN - 1443-1661
pISSN - 0915-5635
DOI - 10.1111/den.13860
Subject(s) - medicine , randomized controlled trial , colonoscopy , laxative , regimen , statistical significance , randomization , bowel preparation , cathartic , colorectal cancer , constipation , cancer
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.