Reisenauer Christl, Andress Jürgen, Schoenfisch Birgitt, Huebner Markus, Brucker Sara Yvonne, Lippkowski Andrea, Beilecke Kathrin, Marschke Juliane, Tunn Ralf
Department of Gynecology and Obstetrics, University Hospital Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.
Women's Center Bern, Bremgartenstrasse 117, 3001, Bern, Switzerland.
Int Urogynecol J. 2022 Feb;33(2):411-419. doi: 10.1007/s00192-021-04853-4. Epub 2021 Jun 8.
The purpose of the study was to analyze anatomical and functional outcomes after sacrocolpopexy (SCP) for vaginal vault prolapse pelvic organ prolapse quantification (POPQ) II-III by random use of absorbable (Vicryl) and non-absorbable sutures (Ethibond) for vaginal mesh fixation.
This study was designed as a two-center randomized controlled study (RCT). The primary objective was to evaluate the anatomical outcome. Success was defined when the vaginal apex (point C; POPQ) did not descend more than 50% of the total vaginal length (tvl) during Valsalva. Patients completed a pelvic examination incorporating the POPQ and questionnaires (the German pelvic floor questionnaire and the PISQ-12 questionnaire) at baseline and 6 months postsurgery. Perioperative adverse events (AE) were recorded. Sample size calculations, based on a 10% non-inferiority limit required 100 participants per group, with power = 90%.
In 190 out of 195 women (ETH group n = 96; VIC group n = 94) anatomical success was achieved. The relative risk of anatomical success failure in the VIC group versus the ETH group was 0.69, with a 95% confidence interval 0.12-4.02. The change in the symptom scores did not differ significantly between the ETH and the VIC group. In the ETH group, three suture penetrations into the vagina were observed, and none in the VIC group 6 months postoperatively.
Anatomical success after SCP for vaginal vault prolapse POPQ II-III is not affected by suture type for vaginal monofilament mesh attachment. Moreover, we did not see any differences in functional outcomes between the two groups. Three suture penetrations into the vagina were observed in the ETH group, and none in the VIC group 6 months postoperatively.
本研究的目的是分析通过随机使用可吸收缝线（薇乔）和不可吸收缝线（爱惜邦）固定阴道网片，对盆腔器官脱垂定量分期（POPQ）为II - III期的阴道穹隆脱垂进行骶骨阴道固定术后的解剖学和功能学结果。
本研究设计为一项双中心随机对照试验（RCT）。主要目标是评估解剖学结果。当在用力屏气时阴道顶端（C点；POPQ）下降不超过阴道总长度（tvl）的50%时，定义为成功。患者在基线和术后6个月完成包含POPQ的盆腔检查以及问卷调查（德国盆底问卷和PISQ - 12问卷）。记录围手术期不良事件（AE）。基于10%的非劣效性界限进行样本量计算，每组需要100名参与者，检验效能为90%。
195名女性中的190名（ETH组n = 96；VIC组n = 94）获得了解剖学成功。VIC组与ETH组解剖学成功失败的相对风险为0.69，95%置信区间为0.12 - 4.02。ETH组和VIC组症状评分的变化无显著差异。在ETH组，术后6个月观察到3例缝线穿透阴道，而VIC组未观察到。
对于POPQ II - III期的阴道穹隆脱垂，骶骨阴道固定术后的解剖学成功不受阴道单丝网片固定缝线类型的影响。此外，我们未观察到两组在功能学结果上有任何差异。术后6个月，ETH组观察到3例缝线穿透阴道，而VIC组未观察到。
