Hyo-Joon Yang1, Soo-Kyung Park1, Jee Hyun Kim2, Jong Pil Im2, Dong Han Yeom3, Geom Seog Seo3, Dong Il Park1. 1. Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. 2. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. 3. Digestive Disease Research Institute, Wonkwang University College of Medicine, Jeonbuk, Korea.
Abstract
BACKGROUND AND AIM: The present study aimed to evaluate the non-inferiority of low-volume oral sulfate solution (OSS) to 4-L polyethylene glycol (PEG) solutions administered in a split-dose regimen as bowel preparation for colonoscopy. The safety and tolerability were also compared between the two regimens. METHODS: In this prospective, randomized, single-blind, active-control, parallel group, and non-inferiority trial, consecutive outpatients and health checkup recipients aged 19-65 years undergoing elective colonoscopy were enrolled to receive OSS or 4-L PEG in a split-dose regimen. The quality of bowel preparation was evaluated using the Boston Bowel Preparation Scale. The occurrence of any adverse events, acceptance, compliance, and satisfaction during bowel preparation were evaluated by participant interviews. RESULTS: Overall, 210 participants were randomized, and 199 were administered by the study agents. Adequate bowel preparation was achieved in 98.0% (97/99) of the OSS group, which was non-inferior to the PEG group (96%; 96/100) with a difference of +2.8% (95% confidence interval; -2.8, +6.8). There were no differences in the incidence of adverse events except for abdominal pain, which was more frequent in the OSS (7.1%, 7/99) than in the PEG (1.0%, 1/100; P = 0.035) group. Acceptance, compliance, and satisfaction were significantly higher in the OSS than in the PEG group (all P < 0.05). CONCLUSIONS:Split-dose OSS was non-inferior to split-dose 4-L PEG with regard to bowel preparation efficacy before colonoscopy in adult outpatients or screening colonoscopy recipients aged ≤65 years withacceptable safety and superior tolerability.
RCT Entities:
BACKGROUND AND AIM: The present study aimed to evaluate the non-inferiority of low-volume oral sulfate solution (OSS) to 4-L polyethylene glycol (PEG) solutions administered in a split-dose regimen as bowel preparation for colonoscopy. The safety and tolerability were also compared between the two regimens. METHODS: In this prospective, randomized, single-blind, active-control, parallel group, and non-inferiority trial, consecutive outpatients and health checkup recipients aged 19-65 years undergoing elective colonoscopy were enrolled to receive OSS or 4-LPEG in a split-dose regimen. The quality of bowel preparation was evaluated using the Boston Bowel Preparation Scale. The occurrence of any adverse events, acceptance, compliance, and satisfaction during bowel preparation were evaluated by participant interviews. RESULTS: Overall, 210 participants were randomized, and 199 were administered by the study agents. Adequate bowel preparation was achieved in 98.0% (97/99) of the OSS group, which was non-inferior to the PEG group (96%; 96/100) with a difference of +2.8% (95% confidence interval; -2.8, +6.8). There were no differences in the incidence of adverse events except for abdominal pain, which was more frequent in the OSS (7.1%, 7/99) than in the PEG (1.0%, 1/100; P = 0.035) group. Acceptance, compliance, and satisfaction were significantly higher in the OSS than in the PEG group (all P < 0.05). CONCLUSIONS: Split-dose OSS was non-inferior to split-dose 4-LPEG with regard to bowel preparation efficacy before colonoscopy in adult outpatients or screening colonoscopy recipients aged ≤65 years with acceptable safety and superior tolerability.
Authors: Milena Di Leo; Andrea Iannone; Monica Arena; Giuseppe Losurdo; Maria Angela Palamara; Giuseppe Iabichino; Pierluigi Consolo; Maria Rendina; Carmelo Luigiano; Alfredo Di Leo Journal: World J Gastroenterol Date: 2021-12-07 Impact factor: 5.742