恶性肠道阻塞患者的手术与非手术治疗 (S1316):实用性比较有效性试验
Robert S Krouse1, Garnet L Anderson2, Kathryn B Arnold2
1Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA; Corporal Michael J Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.
The lancet. Gastroenterology & hepatology
|August 4, 2023
概括
恶性肠道阻塞的手术与非手术治疗对患者的结果没有显著差异. 这两种方法在91天内产生了相似数量的好天,为这种情况做出了明智的临床决定.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 胃肠病学 胃肠病学
背景情况:
- 恶性小肠阻塞呈现出一个糟糕的预后与不清楚的最佳管理策略.
- 这项研究解决了对恶性肠道阻塞的手术与非手术方法进行比较的需要.
研究的目的:
- 为了比较恶性肠道阻塞的手术和非手术治疗方法.
- 确定患有恶性肠道阻塞的患者的最佳治疗方法.
主要方法:
- 在美国,墨西哥,秘鲁和哥伦比亚的30个中心进行的实用性比较疗效试验 (S1316).
- 患有腹部癌症和恶性肠道疾病的参与者被随机分配 (1:1) 进行手术或非手术治疗,并提供患者选择的治疗途径.
- 主要结局是活着的日子和91天出院 (好日子),使用治疗意图原则进行分析.
主要成果:
- 在随机 (42.6 vs 43.9 天) 或患者选择 (54.8 vs 52.7 天) 途径中,在手术和非手术组之间没有观察到"好日子"的显著差异.
- 调整后的平均差异使得外科治疗增加了2.9个良好的日子,但这在统计学上并不显著 (p=0.50).
- 最常见的3-4级并发症是贫血,在手术组中更频繁地发生.
结论:
- 治疗方法 (手术与非手术) 对患有恶性肠道阻塞的患者在91天内良好的日数没有影响.
- 研究结果支持为患有恶性肠道阻塞住院的患者做出明智的决策,考虑手术和非手术选项.
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