Barski Dimitri, Gerullis Holger, Georgas Evangelos, Bär Andreas, Lammers Bernhard, Ramon Albert, Ysebaert Dirk, Klosterhalfen Bernd, Boros Mihaly, Otto Thomas
Department of Urology, Lukas Hospital, 41464 Neuss, Germany.
Department of Urology, Lukas Hospital, 41464 Neuss, Germany ; German Centre for Assessment and Evaluation of Innovative Techniques in Medicine (DZITM), 41464 Neuss, Germany.
Biomed Res Int. 2014;2014:296498. doi: 10.1155/2014/296498. Epub 2014 Sep 16.
Optimized biocompatibility is a major requirement for alloplastic materials currently applied for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) repair. In the preliminary studies the mesh modification by coating with autologous plasma resulted in the increased adherence score in vitro and improved biocompatibility in an animal model. The first use of plasma coated meshes in human is presented.
Between 04/2013 and 05/2014, 20 patients with the indication for SUI and POP repair were selected in a single institution. The applied meshes were modified by autologous plasma coating prior to implantation. A retrospective chart review for peri- and early postoperative complications was performed. Functional outcome and QoL were evaluated pre- and postoperatively.
The functional outcome and QoL improved significantly in all groups. Two reoperations (Grade IIIB) with the release of TVT-mesh in anesthesia due to the obstruction were needed. No other severe complications were registered.
For the first time we applied a mesh modification in a human setting according to IDEAL criteria of surgical innovations. The procedure of mesh coating with autologous plasma is safe and a prospective randomized trial proving a positive effect of plasma coating on the biocompatibility and morbidity outcome with long-term registry is planned.
优化生物相容性是目前用于压力性尿失禁(SUI)和盆腔器官脱垂(POP)修复的异体材料的主要要求。在初步研究中,用自体血浆包被网片可提高体外黏附评分,并改善动物模型中的生物相容性。本文介绍了血浆包被网片在人体中的首次应用。
2013年4月至2014年5月期间,在一家单一机构中选择了20例有SUI和POP修复指征的患者。植入前,应用的网片通过自体血浆包被进行改良。对围手术期和术后早期并发症进行回顾性病历审查。术前和术后评估功能结局和生活质量。
所有组的功能结局和生活质量均显著改善。因梗阻需要进行两次再次手术(IIIB级),在麻醉下松解经阴道无张力尿道中段吊带(TVT)网片。未记录到其他严重并发症。
我们首次根据手术创新的IDEAL标准在人体中应用网片改良。自体血浆包被网片的操作是安全的,计划进行一项前瞻性随机试验,以长期登记证明血浆包被对生物相容性和发病结局的积极作用。