胃切除术后的预防性排水放置和术后的侵入性手术:胃切除术后的腹部排水 (ADIGE) 随机临床试验
Jacopo Weindelmayer1, Valentina Mengardo1, Filippo Ascari2
1General and Upper GI Surgery Division, Azienda Ospedaliera Universitaria Integrata, Borgo Trento, Verona, Italy.
JAMA surgery
|November 27, 2024
概括
建议在癌症胃切除术后进行例行预防性腹部排水,因为避免它增加了术后侵入性手术的需要. 进一步的研究可以确定高风险的患者,以定制的排水策略.
科学领域:
- 手术瘤学手术瘤学
- 胃肠道手术 胃肠道手术
- 临床试验 临床试验
背景情况:
- 癌症胃切除术后的预防性腹部排水是有争议的,小型研究表明潜在的益处,但带有偏差的高风险.
- 需要进一步的研究来确认排水是否有效地识别和管理术后腹膜内收集,从而可能避免重新手术或皮肤通排水.
研究的目的:
- 为了确定是否避免胃切除术后的常规腹腔排水增加了术后侵入性手术的需要.
主要方法:
- 一个多中心前性随机非劣势性试验 (ADIGE试验),涉及404名因癌症而接受胃切除术的患者.
- 患者被随机分配1:1接受预防性腹部排水或没有排水.
- 主要终点是30天内重新手术或皮肤通道排水,使用修改的治疗意图方法进行分析.
主要成果:
- 与排水组 (7.7%) 相比,没有排水的组需要明显更多的重新操作或皮肤通道排水 (15%),有利于使用排水.
- 主要组合终点的差异主要是由于无排水组的重新操作率更高 (12.4%与5.1%相比).
- 与排水有关的并发症不常见 (4名患者).
结论:
- 胃切除术后避免预防性腹部排水会增加术后侵入性手术的风险,因此建议继续使用.
- 未来的研究应该专注于确定特定的患者亚组,他们可能从预防性排水中获益最多.
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