与单独的PCNL相比,PCNL与尿路镜相结合的好处在尿病 (PRECISE):一个多中心随机对照试验协议
Chris A Suijker1, Riemer A Kingma1, Dirk Bakker2
1Department of Urology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
BJU international
|September 25, 2025
概括
内镜联合内手术 (ECIRS) 可能提供比单独的皮肤透神经切除术 (PCNL) 更好的石头清除. PRECISE试验将比较这些技术用于结石,评估疗效,安全性和成本.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 最少侵入性的手术
- 腎石病的管理方法
背景情况:
- 穿皮骨切除术 (PCNL) 经常导致残留结石,增加发病率和重新干预率.
- 内镜联合内外科手术 (ECIRS),结合PCNL与尿尿管镜,呈现出无结石率的潜在改善.
- 由于潜在的风险和资源影响,需要进行全面的随机对照试验来评估ECIRS与PCNL的对比.
研究的目的:
- 为了比较ECIRS与标准PCNL治疗结石的疗效和安全性.
- 评估ECIRS和PCNL之间无石头率,与石头相关的发病率和资源利用率的差异.
- 评估两种手术方法的长期结果,包括成本效益和环境影响.
主要方法:
- PRECISE试验是一项前性,随机的多中心研究,以1:1的比例比较ECIRS和PCNL.
- 将招募350名符合皮肤结石手术条件的成年患者.
- 主要终点是手术后4周的A级 (0毫米) 无结石率,通过CT扫描进行评估.
主要成果:
- 主要终点是手术后4周的A级 (0毫米) 无结石率,通过CT扫描进行评估.
- 二级终点包括各种无结石率 (≤2毫米,≤4毫米),减少结石量,一年无结石率和辐射暴露.
- 其他结果包括并发症,手术时间,与石头有关的事件 (SREs),与健康有关的生活质量 (HRQoL) 和高达5年的成本效益.
结论:
- PRECISE试验将提供关键数据,比较ECIRS与PCNL的有效性和安全性.
- 调查结果将为临床决策提供关于治疗结石的最佳手术方法的信息.
- 这项研究旨在确定ECIRS是否与PCNL相比提供更好的石头清理和降低病率,并对经济和环境因素进行分析.
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