Department of Obstetrics/Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Trials. 2020 Feb 26;21(1):226. doi: 10.1186/s13063-019-3966-3.
Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III-IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.
The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (β = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair.
This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III-IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective.
ClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.
盆腔器官脱垂（POP）是一种常见的健康问题，对女性的生活质量有重大负面影响。经阴道网片修补术是一种持久的重建手术，但网片套件对于欠发达国家来说较为昂贵。我们之前的病例系列研究表明，使用自切网片的成功率较高（1 年随访时为 91.8%），且并发症发生率较低。本试验旨在比较自切钛涂层聚丙烯网片术与网片套件治疗有症状的 III-IV 期前或顶脱垂在疗效、安全性和成本效益方面的差异。
该试验为一项随机对照多中心非劣效性试验。主要结局测量指标为 1 年随访时的复合成功率。次要结局指标为 POP-Q 评分评估各阴道段（前、后和顶）的解剖学结局，问卷调查评估生活质量的主观改善，术中参数、并发症和成本。分析将根据意向治疗原则进行。基于 90%和 10%的可比成功率（β=0.2，单侧α=0.025），总共将从 11 个中心招募约 312 名患者，包括 10%的失访率。本研究旨在证明自切网片术是否不劣于网片套件术，并研究钛涂层网片在阴道脱垂修复中的应用。
本多中心非劣效性试验将评估严重有症状的 III-IV 期前或顶脱垂女性中，自切网片与网片套件在疗效和安全性方面的差异。如果我们能够证明自切网片术在成功率方面不劣于网片套件术，那么自切网片术可能更具成本效益。
ClinicalTrials.gov，NCT03283124。注册于 2018 年 1 月 17 日。
