GatekeeperTM 假肢植入门通道治疗气体失禁和污染:长期随访
Jaume Tur-Martinez1, Laura Lagares-Tena1, Juan Hinojosa-Fano1
1Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain.
Journal of clinical medicine
|October 26, 2024
概括
守门人TM设备为便失禁提供了一种安全的,最少的侵入性治疗方法,显著减少了气体失禁和污染事件. 大多数患者表示满意,并会重复该程序,表明其对难以管理的症状的有效性.
科学领域:
- 胃肠病学 胃肠病学
- 结肠直肠手术 结肠直肠手术
- 医疗器械 医疗器械
背景情况:
- 便失禁 (FI),特别是气体失禁 (GI) 和污染,带来了管理挑战.
- 现有的治疗方法对这些特定的FI亚型具有有限的疗效.
研究的目的:
- 评估GatekeeperTM设备的安全性和有效性,用于治疗主要有污染和/或气体失禁的便失禁.
- 评估患者报告的结果和干预后的禁欲的客观措施.
主要方法:
- 一个前性的,单中心病例系列,涉及13名用多烯酸假肢 (GatekeeperTM) 治疗的患者.
- 在基线和随访间隔长达24个月时,使用日记,圣马克得分,视觉模拟量表 (VAS),3D-内腔超声波和直肠计量来评估禁欲.
- 关键的结果措施包括减少污染和胃肠道发作以及患者满意度.
主要成果:
- 在所有患者中,GatekeeperTM植入程序都没有任何事件.
- 一年后观察到污染和胃肠道发作显著减少 (p=0.002对于污染,p=0.01对于胃肠道).
- 患者报告的结局显示VAS得分有显著改善 (p=0.03),70%的患者愿意重复治疗.
结论:
- GatekeeperTM是一种安全的,最少的侵入性选择,用于管理便失禁,特别是污垢和气体失禁.
- 该设备显示症状显著减少,污染明显改善.
- 需要进一步的研究来证实这些研究结果在更大的FI亚型患者队列中.
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