Effect of Dose Interval of Oral Sulfate Solution on Bowel Preparation Quality: A Multicenter Noninferiority Randomized Controlled Trail
Author(s)
Xiangyu Sui, MD1, Yi Zeng, MD2, Zhiyao Huang, MD1, Zhaoshen Li, MD,PhD1, Shengbing Zhao, MD1, Yu Bai, MD,PhD1.
1Department of Gastroenterology, Changhai Hospital, Shanghai, China, 2Department of Colorectal Surgery, Changhai Hospital, Shanghai, China.
1Department of Gastroenterology, Changhai Hospital, Shanghai, China, 2Department of Colorectal Surgery, Changhai Hospital, Shanghai, China.
OBJECTIVES: Although split-dose bowel preparation is recommended to optimize colon cleansing, no standardized dosing regimen has been established. This study aimed to evaluate whether different dose intervals of oral sulfate solution (OSS) affect the bowel preparation quality in a split-dose regimen.
METHODS: This endoscopist-blinded, noninferiority randomized controlled trial was conducted across 17 centers in China between March and December 2024. Participants were randomized 1:1 into either the short-interval group, with a 6-8 hours interval between doses, or the long-interval group, with a 10-12 hours interval. The primary outcome was the rate of adequate bowel preparation, defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 and each segment score ≥2. The study population was divided into the intention-to-treat (ITT) set and the per-protocol (PP) set.
RESULTS: A total of 551 participants were randomized, 546 were included in the ITT analysis, and 405 completed the PP analysis. In the ITT analysis, the short-interval group showed no significant difference in the adequate bowel preparation rate compared with the long-interval group (96.7% vs. 97.8%, P=0.441), with a difference of -1.08% (95% CI: -3.82%, 1.66%). Similarly, no significant difference was observed in the PP analysis (97.51% vs. 99.02%, difference= -1.51%, 95% CI: -4.05%, 1.04%, P = 0.434). No significant differences were observed in polyp detection rate (55.5% vs. 56.3%, P=0.855), adenoma detection rate (33.9% vs. 37.9%, P=0.339), adverse events (35.0% vs. 30.5%, P=0.260), or changes in peripheral blood electrolytes (all P > 0.05) between the short and long-interval groups.
CONCLUSIONS: The short and long dose intervals of OSS showed comparable efficacy and safety in split-dose regimen, supporting flexible administration timing without compromising bowel preparation quality.
METHODS: This endoscopist-blinded, noninferiority randomized controlled trial was conducted across 17 centers in China between March and December 2024. Participants were randomized 1:1 into either the short-interval group, with a 6-8 hours interval between doses, or the long-interval group, with a 10-12 hours interval. The primary outcome was the rate of adequate bowel preparation, defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 and each segment score ≥2. The study population was divided into the intention-to-treat (ITT) set and the per-protocol (PP) set.
RESULTS: A total of 551 participants were randomized, 546 were included in the ITT analysis, and 405 completed the PP analysis. In the ITT analysis, the short-interval group showed no significant difference in the adequate bowel preparation rate compared with the long-interval group (96.7% vs. 97.8%, P=0.441), with a difference of -1.08% (95% CI: -3.82%, 1.66%). Similarly, no significant difference was observed in the PP analysis (97.51% vs. 99.02%, difference= -1.51%, 95% CI: -4.05%, 1.04%, P = 0.434). No significant differences were observed in polyp detection rate (55.5% vs. 56.3%, P=0.855), adenoma detection rate (33.9% vs. 37.9%, P=0.339), adverse events (35.0% vs. 30.5%, P=0.260), or changes in peripheral blood electrolytes (all P > 0.05) between the short and long-interval groups.
CONCLUSIONS: The short and long dose intervals of OSS showed comparable efficacy and safety in split-dose regimen, supporting flexible administration timing without compromising bowel preparation quality.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO83
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Gastrointestinal Disorders