Clinical and translational gastroenterology · 2023
Bowel Preparation Efficacy and Safety of 1 L vs 2 L Polyethylene Glycol With Ascorbic Acid for Colonoscopy: A Randomized Controlled Trial.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод в очереди
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Jeon Han Jo, Keum Bora, Bang Eun Ju, Lee Kang Won, Kim Sang Hyun, Lee Jae Min, Choi Hyuk Soon, Kim Eun Sun, Jeen Yoon Tae, Lee Hong Sik, Chun Hoon Jai
Аннотация
INTRODUCTION: Polyethylene glycol with ascorbic acid (PEG/Asc) is a well-established bowel preparation solution with guaranteed effectiveness and safety. A new low-volume agent, 1 L-PEG/Asc, has recently been released. This study aimed to compare the bowel cleansing efficacy and safety of 1 L-PEG/Asc and 2 L-PEG/Asc administered to adult outpatients in a split-dose manner.
METHODS: Outpatients undergoing colonoscopy enrolled in a single-blinded, single-center, noninferiority study conducted between July and October 2021 were randomized in a 1:1 manner to a 1 L-PEG/Asc or 2 L-PEG/Asc group. Bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale in intention-to-treat and per-protocol populations.
RESULTS: Two hundred forty participants were randomized and allocated, with 120 patients in the 1 L and 2 L-PEG/Asc groups, respectively. Noninferiority was demonstrated for overall successful bowel cleansing (BBPS: 92.5% vs 90.8%; 95% confidence interval [CI], -0.054 to 0.087) and the high-quality cleansing rate of the right-sided colon (BBPS = 3, 40.0% vs 35.8%; 95% CI, -0.082 to 0.165; Harefield Cleansing Scale ≥3, 50.0% vs 43.3%; 95% CI, -0.060 to 0.194) in the intention-to-treat population. The overall incidence of adverse events was similar in both groups ([82/120] 68.3% vs [72/120] 60.0%; P = 0.178). The tolerability, acceptability, and compliance rates of both regimens were similar, with no significant differences.
DISCUSSION: Compared with 2 L-PEG/Asc, 1 L-PEG/Asc achieved successful overall bowel cleansing efficacy with high-quality cleansing in the proximal colon and proved its noninferiority. Therefore, 1 L-PEG/Asc is an acceptable alternative bowel cleansing solution.
METHODS: Outpatients undergoing colonoscopy enrolled in a single-blinded, single-center, noninferiority study conducted between July and October 2021 were randomized in a 1:1 manner to a 1 L-PEG/Asc or 2 L-PEG/Asc group. Bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale in intention-to-treat and per-protocol populations.
RESULTS: Two hundred forty participants were randomized and allocated, with 120 patients in the 1 L and 2 L-PEG/Asc groups, respectively. Noninferiority was demonstrated for overall successful bowel cleansing (BBPS: 92.5% vs 90.8%; 95% confidence interval [CI], -0.054 to 0.087) and the high-quality cleansing rate of the right-sided colon (BBPS = 3, 40.0% vs 35.8%; 95% CI, -0.082 to 0.165; Harefield Cleansing Scale ≥3, 50.0% vs 43.3%; 95% CI, -0.060 to 0.194) in the intention-to-treat population. The overall incidence of adverse events was similar in both groups ([82/120] 68.3% vs [72/120] 60.0%; P = 0.178). The tolerability, acceptability, and compliance rates of both regimens were similar, with no significant differences.
DISCUSSION: Compared with 2 L-PEG/Asc, 1 L-PEG/Asc achieved successful overall bowel cleansing efficacy with high-quality cleansing in the proximal colon and proved its noninferiority. Therefore, 1 L-PEG/Asc is an acceptable alternative bowel cleansing solution.