Galilee Medical Center- Women's Health Division, Nahariya, Israel; The Azrieli Faculty of Medicine of Bar-Ilan Universit, Safed, Israel.
Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.
Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:180-185. doi: 10.1016/j.ejogrb.2024.10.032. Epub 2024 Oct 24.
Vaginal hysterectomy combined with uterosacral suspension (USLS) is a technique for treating pelvic organ prolapse. Vaginal natural orifice transluminal endoscopic surgery (vNOTES) has been described as an alternative minimal invasive approachfor treating various gynecological and non-gynecological pathologies. The aim was to compare the surgical time between conventional vaginal hysterectomy combined with USLS and vNOTES hysterectomy combined with USLS.
Multi-center randomized controlled trial performed 2019-2021 at Rambam Health Care Campus (Israel) and Imelda Hospital (Belgium). Thirty women underwent vNOTES procedures and 30 women underwent conventional vaginal procedures. The primary outcome was total surgical time. Secondary outcomes included hysterectomy time, USLS time, intraoperative bleeding, length of hospitalization, pain during the first 24 h postoperative, the need of analgesia, intraoperative and postoperative adverse events, and patient-reported outcomes questionnaires. Parametric statistical methods were used to analyze the data.
Compared to conventional vaginal procedures, vNOTES procedures were shorter in total surgical time (77 vs. 93 min, p = 0.004), hysterectomy time (26 vs 33 min, p < 0.001), and USLS time (20 vs 26 min. p = 0.02). Blood loss was higher in conventional vaginal compared to vNOTES surgery, as reflected by the mean blood loss estimate (143 vs 60 ml. p < 0.001) and the delta-hemoglobin (pre-operation minus the post-operation hemoglobin level (1.8 vs 1.2 ml/dL, p = 0.01). There was no difference between the groups regarding analgesics used, postoperative pain, surgical objective outcomes, and scores on patient-reported outcomes questionnaires. Adverse events were significantly more frequent in the conventional vaginal group than in the vNOTES group (p < 0.001 for intraoperative events and p = 0.05 for events that occurred in the follow-up time interval).
vNOTES hysterectomy with USLS has lower surgical times than conventional vaginal hysterectomy with USLS, lower blood loss and less adverse events. Other surgical objective and subjective outcomes were similar between the approaches.
阴道子宫切除术联合子宫骶骨悬吊术（USLS）是治疗盆腔器官脱垂的一种技术。阴道自然腔道内镜手术（vNOTES）已被描述为治疗各种妇科和非妇科疾病的一种替代微创方法。本研究旨在比较传统阴道子宫切除术联合 USLS 与 vNOTES 子宫切除术联合 USLS 的手术时间。
2019 年至 2021 年在以色列 Rambam 医疗保健园区和比利时 Imelda 医院进行的多中心随机对照试验。30 名女性接受 vNOTES 手术，30 名女性接受传统阴道手术。主要结局是总手术时间。次要结局包括子宫切除术时间、USLS 时间、术中出血、住院时间、术后 24 小时内疼痛、镇痛需求、术中及术后不良事件以及患者报告的结果问卷。采用参数统计方法分析数据。
与传统阴道手术相比，vNOTES 手术的总手术时间（77 分钟 vs. 93 分钟，p=0.004）、子宫切除术时间（26 分钟 vs. 33 分钟，p<0.001）和 USLS 时间（20 分钟 vs. 26 分钟，p=0.02）更短。传统阴道手术的术中出血量高于 vNOTES 手术，术中出血量估计均值（143 毫升 vs. 60 毫升，p<0.001）和 delta-血红蛋白（手术前减去手术后的血红蛋白水平（1.8 毫升/分升 vs. 1.2 毫升/分升，p=0.01）也有所升高。两组在使用的镇痛药、术后疼痛、手术客观结局以及患者报告的结果问卷评分方面无差异。传统阴道组的不良事件明显多于 vNOTES 组（术中事件 p<0.001，随访期间发生的事件 p=0.05）。
vNOTES 子宫切除术联合 USLS 的手术时间短于传统阴道子宫切除术联合 USLS，出血量少，不良事件少。两种方法的其他手术客观和主观结局相似。
