Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, The Republic of Korea
Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, The Republic of Korea.
BMJ Open. 2020 Jun 16;10(6):e034218. doi: 10.1136/bmjopen-2019-034218.
The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels and regains maximum tensile strength. Nonetheless, no comparative data exist about the relative efficacy and safety of anterior colporrhaphy using non-absorbable versus absorbable sutures. The objective of this study is to compare the surgical outcomes of anterior colporrhaphy using non-absorbable sutures with those of anterior colporrhaphy using absorbable sutures.
This is a randomised, multicentre, superiority trial. Anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either non-absorbable or absorbable sutures. The primary outcome is composite surgical success 1 year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary. The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. The planned number of participants is 192.
This study was approved by the Institutional Review Board of Seoul National University Hospital (H-1810-037-977). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
NCT03736811.
阴道前壁是最常发生脱垂的部位。传统上，阴道前壁脱垂通过阴道前修补术进行修复，但该手术复发率较高。有几个因素可能会影响阴道前修补术的结果，而使用可吸收缝线也可能与高复发率有关，因为缝线可能无法保持足够的强度，直到缝合的耻骨宫颈筋膜重塑并恢复最大拉伸强度。尽管如此，关于使用不可吸收缝线与可吸收缝线进行阴道前修补术的相对疗效和安全性，尚无比较数据。本研究的目的是比较使用不可吸收缝线与使用可吸收缝线进行阴道前修补术的手术结果。
这是一项随机、多中心、优效性试验。将采用传统方法，使用不可吸收或可吸收缝线对纤维肌肉层进行中线缝合，进行阴道前修补术。主要结局是术后 1 年的综合手术成功率，定义为不存在以下所有情况：（1）阴道前壁下降超过处女膜，（2）存在阴道膨出症状，（3）因复发性阴道前壁脱垂而再次接受手术或阴道托治疗。次要结局包括复合主要终点的各个组成部分、解剖学结局、特定于疾病的生活质量和与阴道前修补术相关的不良事件。计划的参与者人数为 192 人。
本研究已获得首尔国立大学医院机构审查委员会的批准（H-1810-037-977）。研究结果将发表在同行评议的期刊上，并将在科学会议上报告。
NCT03736811。
