Saint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.
Trials. 2024 Oct 2;25(1):647. doi: 10.1186/s13063-024-08448-4.
Pelvic organ prolapse (POP) is one of the most common pathologies of the pelvic floor, and it can be found among 40-60% of women who have given birth. Correction of the defect of the DeLancey level II without reconstruction of the apical defect is doomed to failure. Also, in the structure of pelvic floor defects, there is often an incompetency of the perineal body, as a consequence of traumatic delivery. Perineoplasty is considered to be the main method of correction for perineal body incompetency. However, it is worth mentioning that there are no randomized trials, which estimate the influence of simultaneous correction of the perineal body on the effectiveness of transvaginal apical fixation.
It is planned to include 310 patients in this trial. Patients who met the inclusion/exclusion criteria will be randomized into 2 groups: 1st group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy without perineoplasty, 2nd group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy and perineoplasty. Patients will be called to an appointment 6, 12, and 24 months after discharge.
The aim of this trial is to evaluate the efficiency and safety of simultaneous perineoplasty on the clinical and anatomical efficacy of mesh-augmented sacrospinal fixation in advanced pelvic organ prolapse repair. Based on previous studies, it was difficult to estimate and comprehend whether colpoperinoplasty actually reduces the risk of prolapse recurrence.
NCT05422209. Registered on 18 May 2022.
盆腔器官脱垂（POP）是盆底最常见的病理之一，在分娩过的女性中，有 40%-60%会出现这种情况。如果不重建顶点缺陷，仅纠正 DeLancey II 级缺陷，注定会失败。此外，在盆底缺陷的结构中，常常存在会阴体的功能不全，这是分娩创伤的结果。会阴成形术被认为是纠正会阴体功能不全的主要方法。然而，值得注意的是，目前尚无随机试验评估同期纠正会阴体对阴道顶点固定效果的影响。
计划在这项试验中纳入 310 名患者。符合纳入/排除标准的患者将随机分为 2 组：第 1 组患者将接受网片增强的脊柱固定术，同时行前、后阴道修补术，不进行会阴成形术；第 2 组患者将接受网片增强的脊柱固定术，同时行前、后阴道修补术和会阴成形术。患者将在出院后 6、12 和 24 个月预约就诊。
本试验的目的是评估同期会阴成形术对网片增强的脊柱固定术治疗晚期盆腔器官脱垂修复的临床和解剖效果的有效性和安全性。基于先前的研究，很难评估和理解会阴成形术是否确实降低了脱垂复发的风险。
NCT05422209。于 2022 年 5 月 18 日注册。
