Department of Surgery, "Achillopouleion" General Hospital, Volos, Greece.
Department of Surgery, University Hospital of Larissa, Larissa, Greece.
Langenbecks Arch Surg. 2024 Mar 19;409(1):98. doi: 10.1007/s00423-024-03288-x.
Magnetic anal sphincter (MAS) augmentation is a novel surgical option for the treatment of fecal incontinence. Current clinical evidence is conflicting. The purpose of this meta-analysis was to report the safety profile, potential benefits, and the functional efficacy of this device.
The study followed the PRISMA guidelines. Literature databases (Medline, Scopus, Web of Science, CENTRAL) were screened for eligible articles. The primary endpoint was the pooled effect of MAS in the Cleveland Clinic Incontinence Score (CCIS) score. Quality evaluation was based on the ROBINS-I and Risk of Bias 2 tool.
Overall, 8 studies with 205 patients were included. MAS resulted in a significant reduction of CCIS values (p = 0.019), and improvement only in the embarrassment domain of FIQoL scores (p = 0.034). The overall morbidity rate was 61.8%. Postoperative adverse events included MAS explantation in 12%, infection in 5.1%, pain in 10% and obstructed defecation in 5.8% of patients.
The application of MAS in patients with fecal incontinence results in the improvement of some clinical parameters with a notable morbidity rate. Due to several study limitations, further, high-quality RCTs are required to delineate the efficacy and safety of MAS.
磁性肛门括约肌（MAS）增强术是治疗粪便失禁的一种新的手术选择。目前的临床证据存在争议。本荟萃分析的目的是报告该设备的安全性概况、潜在益处和功能疗效。
本研究遵循 PRISMA 指南。筛选了 Medline、Scopus、Web of Science 和 CENTRAL 等文献数据库中符合条件的文章。主要终点是 MAS 在克利夫兰诊所失禁评分（CCIS）中的汇总效果。质量评估基于 ROBINS-I 和偏倚风险 2 工具。
共有 8 项研究纳入了 205 例患者。MAS 显著降低了 CCIS 值（p=0.019），仅在 FIQoL 评分的尴尬域有所改善（p=0.034）。总体发病率为 61.8%。术后不良事件包括 MAS 植入物取出 12%、感染 5.1%、疼痛 10%和排便梗阻 5.8%。
在粪便失禁患者中应用 MAS 可改善某些临床参数，但发病率较高。由于存在一些研究局限性，需要进一步开展高质量的 RCT 来明确 MAS 的疗效和安全性。
