同一天的AMBULATORY c (SAMBA):一个多中心,前性,随机临床试验协议.
Catherine Arvieux1,2, Fatah Tidadini3,4, Sandrine Barbois3
1Department of Digestive and Emergency Surgery, Grenoble Alpes University Hospital, Grenoble, France. carvieux@chu-grenoble.fr.
Trials
|September 9, 2024
概括
针对急性尾炎的门诊尾切除正在被测试与住院护理在一个大型的试验. 这项研究旨在证实其安全性和可行性,潜在地改善患者康复和医院效率.
科学领域:
- 手术方面的创新.
- 临床试验方法论的方法论.
- 胃肠道手术 胃肠道手术
背景情况:
- 以前的元分析表明,门诊尾切除术是可行的和安全的.
- 由于缺乏高质量的证据,需要进行随机对照试验.
- 门诊尾切除术旨在降低医疗保健成本并改善患者的体验.
研究的目的:
- 为了证明门诊尾切除术与住院尾切除术的非劣势.
- 主要终点:手术后30天的整体疾病死亡率 (D30).
- 评估门诊尾切除术对无并发性急性尾炎的可行性和可靠性.
主要方法:
- 未来的,随机的,受控的,多中心的非劣势性试验 (SAMBA).
- 1400名患者 (15-74岁) 患有急性无并发性尾炎,正在进行腹腔镜检查.
- 随机分配到门诊 (日间手术) 或住院护理;主要结局D30病死率.
主要成果:
- 数据收集正在进行中;结果尚未提供.
- 研究时间:2023年1月至2025年6月.
- 二次结果包括重新住院,重新干预,以及患者报告的结果.
结论:
- 萨姆巴试验将为门诊尾切除提供关键证据.
- 结果将为临床实践和医院管理策略提供信息.
- 成功实施依赖于适当的技术基础设施.
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