OBJECTIVES The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding. METHODS This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay. RESULTS Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups. DISCUSSION Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.

中文翻译：

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消化性溃疡出血患者内镜止血后喂养的最佳时机

目的 消化性溃疡出血患者内镜止血后的最佳禁食持续时间尚未确定。我们研究了消化性溃疡高危出血患者内镜止血后进食的适当时机。方法 本研究是一项随机、单中心、非劣效性试验。2014 年 2 月至 2019 年 3 月期间，连续出现消化性溃疡出血的患者被随机分配至成功内镜止血后 24 或 48 小时恢复进食。共有 209 名符合条件的患者被纳入意向治疗分析，200 名符合方案 (PP) 分析。主要结局指标是止血后 7 天内的复发性出血。在 PP 人群中进行了非劣效性检验，非劣效性边际设定为 10%。次要结果包括 30 天再出血和死亡率、输血需求和住院时间。结果 在 PP 分析中，24 小时组和 48 小时组 7 天时的再出血率为 7.9% 和 4.0%；非劣效性检验未达到统计学显着性（差异：3.9%，95% 置信区间 [CI]：-2.7 至 10.5，非劣效性 P 值 = 0.034）。24 小时组和 48 小时组 30 天内再出血率分别为 10.9% 和 4.0%（差异：6.9%，95% CI：-0.5 至 14.2），30 天死亡率分别为 5.9% 和 14.1 %，分别在 PP 分析中（差异：-8.2%、95% CI：-16.5 到 0.1）。两组的输血需求和住院时间相似。讨论 对于高危消化性溃疡出血患者，内镜止血后 24 小时早期再喂养并非不劣于 48 小时后再喂养。我们的结果不允许建议在 24 小时内重新喂养，而不是在该人群中稍后重新喂养。