Gerullis Holger, Barski Dimitri, Georgas Evangelos, Borós Mihaly, Ramon Albert, Ecke Thorsten H, Selinski Silvia, Luedders Dörte, Kramer Mario W, Winter Alexander, Wawroschek Friedhelm, Otto Thomas
Department of Urology, Lukas Hospital Neuss, Neuss, Germany.
University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.
Adv Ther. 2017 Apr;34(4):995-1006. doi: 10.1007/s12325-017-0493-z. Epub 2017 Feb 23.
Mesh-related complications especially after vaginal implantation have raised awareness lately because of severe adverse reactions and legal aspects. About 20% of patients suffer from complications after mesh insertion in the anterior vaginal wall. Autologous plasma coating of meshes prior to implantation has shown potential to improve the biocompatibility of meshes in vivo and in vitro. This innovative approach has been developed according to the IDEAL recommendations for surgical innovations. The method has still to be assessed at stage 3 accordingly.
A protocol is developed for a prospective single-blinded randomized controlled phase II trial for biocompatibility optimization of anterior vaginal meshes for prolapse repair by autologous plasma coating versus non-coated meshes.
The protocol aims at fulfilling the requirements for stage 3 (assessment) according to IDEAL. Eligible for inclusion are women with primary cystocele, requiring a surgical procedure, suitable for randomization, and willing to be randomized. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomization) and will also be reviewed in clinic 12 and 24 months post surgery. Primary endpoint is the assessment of mesh-related complications following the Clavien-Dindo classifications. QoL, sexual function assessment, efficacy, and validation of an already developed long-term register are considered secondary endpoints. To afford a calculated 10% reduction of postoperative complications through plasma-coated meshes vs. non-coated meshes at 1-year follow-up, a total 214 women in each arm will be necessary to achieve 80% power at a significance level of 5%.
The protocol for this randomized clinical trial represents the conditions to assess the surgical innovation of plasma coating of meshes in order to improve the meshes' biocompatibility at stage 3 according to the IDEAL recommendations.
由于严重的不良反应和法律问题，与网片相关的并发症尤其是阴道植入后引起了人们的关注。在前阴道壁植入网片后，约20%的患者会出现并发症。在植入前对网片进行自体血浆包被已显示出在体内和体外改善网片生物相容性的潜力。这种创新方法是根据手术创新的IDEAL建议开发的。因此，该方法仍需在3期进行评估。
制定了一项前瞻性单盲随机对照II期试验方案，用于比较自体血浆包被与未包被的前阴道脱垂修复网片的生物相容性优化。
该方案旨在满足IDEAL对3期（评估）的要求。纳入标准为患有原发性膀胱膨出、需要手术治疗、适合随机分组且愿意被随机分组的女性。参与者将通过邮寄问卷进行随访（术后6个月和随机分组后12个月），并在术后12个月和24个月进行临床复查。主要终点是根据Clavien-Dindo分类法评估与网片相关的并发症。生活质量、性功能评估、疗效以及对已建立的长期登记册的验证被视为次要终点。为了在1年随访时通过血浆包被网片与未包被网片相比使术后并发症减少10%，每组共需要214名女性，以在5%的显著性水平下达到80%的检验效能。
该随机临床试验方案代表了评估网片血浆包被手术创新的条件，以便根据IDEAL建议在3期改善网片的生物相容性。
