Noé Günter K, Schiermeier Sven, Papathemelis Thomas, Fuellers Ulrich, Khudyakovd Alexander, Altmann Harald-Hans, Borowski Stefan, Morawski Pawel P, Gantert Markus, De Vree Bart, Tkacz Zbigniew, Ugarteburu Rodrigo Gil, Anapolski Michael
Department of Obstetrics and Gynecology, University of Witten-Herdecke, Rheinlandclinics Dormagen, 41540 Dormagen, Germany.
Department of Obstetrics and Gynecology, University Witten-Herdecke, 258452 Witten, Germany.
J Clin Med. 2021 Jan 9;10(2):217. doi: 10.3390/jcm10020217.
Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210-5.). The short-term follow-up of this international multicenter study carried out now is presented in this article.
Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12-18 months.
The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period.
In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.
几个国家已在努力采用传统的天然组织修复策略并减少网片的使用。将天然组织修复与在顶端修复中应用足够的网片相结合可能提供一种有效的治疗方法。该研究小组确实进行并发表了一项随机试验，重点是传统天然组织修复与耻骨后膀胱颈悬吊术或骶骨阴道固定术的联合应用，且未观察到患者有严重或前所未知的风险（Noé G.K. 《Journal of Endourology》2015年；29(2):210 - 5）。本文介绍了目前这项国际多中心研究的短期随访情况。
四个欧洲国家的11家诊所和13名外科医生参与了该试验。为确保采用标准化方法并获得可比数据，所有外科医生都必须遵循耻骨后膀胱颈悬吊术的标准化方法，重点关注固定区域和预制网片（PVDF PRP 3×15 Dynamesh）的使用。该网片仅用于顶端修复。所有其他临床相关缺陷均采用天然组织修复治疗。采用阴道前壁修补术或经阴道无张力尿道中段吊带术治疗尿失禁。数据在安全服务器上独立收集14个月；登记并评估了501例手术。479例患者中有264例（55.1%）在12 - 18个月后返回进行体格检查和访谈。
平均随访时间为15个月。顶端修复的总体成功率得到96.9%的积极评价，满意度评分得到95.5%的积极评价。95.1%的患者给出了积极的总体推荐。95.2%的患者盆腔压力降低，98.0%的患者疼痛减轻，86.0%的患者尿急症状缓解。随访期间未发生重大并发症、网片暴露或网片相关并发症。
在临床常规中，耻骨后膀胱颈悬吊术及同期手术，主要采用天然组织修复方法，导致了高满意率和良好的临床结果。该手术也可推荐给有腹腔镜经验的普通妇科泌尿医生使用。
