Revista espanola de enfermedades digestivas · 2026
One-liter polyethylene glycol with ascorbic acid provides comparable cleansing quality to two-liter regimen in bowel preparation for patients with inactive ulcerative colitis ‒ A randomized, multicenter, single-blind trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Lee Ji Min, Lee Kang-Moon, Shin Sung Jae, Kim Duk Hwan
Аннотация
INTRODUCTION: patient-centered care for ulcerative colitis (UC) involves reducing the burden associated with colonoscopy, particularly bowel preparation. Although low-volume preparations have become common in the general population, data on the use of 1-l polyethylene glycol with ascorbic acid (PEG+Asc) in patients with UC are limited. We compared the efficacy, safety, and acceptability of 1-l and 2-l PEG+Asc in patients with quiescent UC.
METHODS: this was a multicenter, randomized, single-blind, non-inferiority study. Adult outpatients with UC who had stable disease activity were randomly allocated to 1-l or 2-l of PEG+Asc for colonoscopy. The degree of bowel cleansing was assessed using the Boston Bowel Preparation Scale and rated as successful cleansing if the score was ≥ 6 with all segment scores ≥ 2. Patient acceptance (ease of administration and willingness to repeat) and tolerability (newly developed symptoms, such as nausea, bloating, and abdominal pain) were assessed using a four-point ordinal scale. Disease activity (partial or full Mayo score) and laboratory data before and after colonoscopy were assessed for safety concerns.
RESULTS: of the 196 randomized patients, 74 in the 1-l group and 70 in the 2-l group, respectively, completed the study. Successful cleansing was achieved in 98.6 % and 97.1 % of patients, respectively (absolute difference -1.4 %, one-sided 97.5 % confidence interval -5.9 %), meeting the non-inferiority margin in the per-protocol analysis. A conservative intention-to-treat analysis did not meet the non-inferiority threshold. Overall tolerability and acceptability were similar, although nausea was reported more frequently in the 1-l group. No significant changes in disease activity were observed, and minor electrolyte shifts occurred more often in the 1-l group but were clinically insignificant.
CONCLUSIONS: one-liter PEG+Asc is effective and safe for bowel preparation in patients with quiescent UC and offers a viable low-volume alternative to the 2-l regimen. Careful patient selection and monitoring may be advisable in elderly or comorbid patients.
METHODS: this was a multicenter, randomized, single-blind, non-inferiority study. Adult outpatients with UC who had stable disease activity were randomly allocated to 1-l or 2-l of PEG+Asc for colonoscopy. The degree of bowel cleansing was assessed using the Boston Bowel Preparation Scale and rated as successful cleansing if the score was ≥ 6 with all segment scores ≥ 2. Patient acceptance (ease of administration and willingness to repeat) and tolerability (newly developed symptoms, such as nausea, bloating, and abdominal pain) were assessed using a four-point ordinal scale. Disease activity (partial or full Mayo score) and laboratory data before and after colonoscopy were assessed for safety concerns.
RESULTS: of the 196 randomized patients, 74 in the 1-l group and 70 in the 2-l group, respectively, completed the study. Successful cleansing was achieved in 98.6 % and 97.1 % of patients, respectively (absolute difference -1.4 %, one-sided 97.5 % confidence interval -5.9 %), meeting the non-inferiority margin in the per-protocol analysis. A conservative intention-to-treat analysis did not meet the non-inferiority threshold. Overall tolerability and acceptability were similar, although nausea was reported more frequently in the 1-l group. No significant changes in disease activity were observed, and minor electrolyte shifts occurred more often in the 1-l group but were clinically insignificant.
CONCLUSIONS: one-liter PEG+Asc is effective and safe for bowel preparation in patients with quiescent UC and offers a viable low-volume alternative to the 2-l regimen. Careful patient selection and monitoring may be advisable in elderly or comorbid patients.