Chen Yang-Tao, Wang Zhao-Chu, Xie Ya-Meng, Wang Xun, Wu Xu-Xiong, Li Yang, Shi Rong, Wang Jing
The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, No. 602, Bay17 Middle Road, Fuzhou 350004, China.
Surg Open Sci. 2025 May 30;27:15-30. doi: 10.1016/j.sopen.2025.05.010. eCollection 2025 Sep.
Transanal Opening of Intersphincteric Space (TROPIS) has emerged as a promising surgical approach for anal fistula management over recent years. This meta-analysis comprehensively evaluates the comparative efficacy and safety of TROPIS versus conventional treatments through systematic analysis of 24 clinical studies involving 2813 patients. Through systematic searches across 7 major biomedical databases (including PubMed, EMBASE, and Chinese repositories) from inception to March 2024, we identified comparative studies assessing TROPIS against six established interventions: incision-thread-drawing, seton placement, LIFT, EAFR, fistulotomy, and incision-suture techniques. Pooled analysis demonstrated TROPIS achieved superior clinical outcomes, with a 3.15-fold higher total efficacy rate (95 % CI 1.22-8.13, = 0.02) and 64 % lower complication risk compared to conventional methods (OR 0.28, 95 % CI 0.18-0.42, < 0.00001). Sensitivity analyses confirmed result stability across study designs, while publication bias assessment via funnel plots and Egger's test revealed no significant distortion. Importantly, TROPIS maintained its advantage across various complication subtypes including incontinence (OR 0.31), infection (OR 0.27), and recurrence (OR 0.19). These findings establish TROPIS as a clinically superior alternative that significantly improves therapeutic outcomes while reducing procedure-related risks, suggesting its potential to become the new reference standard in anal fistula management. The consistent results across diverse patient populations and comparator procedures underscore the robustness of this evidence synthesis.
经肛门括约肌间间隙开放术（TROPIS）近年来已成为一种有前景的肛瘘治疗手术方法。这项荟萃分析通过对涉及2813例患者的24项临床研究进行系统分析，全面评估了TROPIS与传统治疗方法相比的疗效和安全性。通过对7个主要生物医学数据库（包括PubMed、EMBASE和中文数据库）从建库至2024年3月进行系统检索，我们确定了评估TROPIS与六种既定干预措施对比的研究：切开挂线、挂线疗法、括约肌间瘘管结扎术（LIFT）、内镜辅助肛瘘修复术（EAFR）、肛瘘切开术和切开缝合技术。汇总分析表明，与传统方法相比，TROPIS取得了更好的临床效果，总有效率高出3.15倍（95%CI 1.22 - 8.13，P = 0.02），并发症风险降低64%（OR 0.28，95%CI 0.18 - 0.42，P < 0.00001）。敏感性分析证实了研究设计结果的稳定性，而通过漏斗图和Egger检验进行的发表偏倚评估显示无显著偏差。重要的是，TROPIS在包括失禁（OR 0.31）、感染（OR 0.27）和复发（OR 0.19）在内的各种并发症亚型中均保持优势。这些发现确立了TROPIS作为临床上更优的替代方法，可显著改善治疗效果并降低手术相关风险，表明其有可能成为肛瘘治疗的新参考标准。不同患者群体和对照手术的一致结果强调了这一证据综合分析的稳健性。
