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机器人经腹腔镜单部位与机器人多部位经阴道骶骨阴道固定术治疗阴道顶端脱垂的比较。

Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse.

机构信息

Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.

Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.

出版信息

Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.

Abstract

BACKGROUND

Sacrocolpopexy is a commonly performed procedure for repair of apical compartment prolapse. A Y-shaped mesh is attached to the prolapsed cervix or vagina and suspended to the anterior longitudinal ligament of the sacrum. In addition to conventional laparoscopic and multi-port robotic routes, the robotic laparoendoscopic single-site approach has emerged as a viable, feasible, and widely applicable minimally invasive approach to sacrocolpopexy.

OBJECTIVE

To compare robotic laparoendoscopic single-site with multi-port robotic sacrocolpopexy for women with either utero-vaginal or vaginal apical prolapse.

MATERIALS AND METHODS

In this single-center randomized controlled trial, 70 women at Pelvic Organ Prolapse Quantitative stages 2-4 were assigned randomly to undergo sacrocolpopexy by robotic laparoendoscopic single-site or multi-port robotic approaches from August 2017 to November 2018. Of 35 women randomized to each group, 32 underwent sacrocolpopexy. Operating time was the primary outcome of the trial. Secondary outcomes included intraoperative bleeding, length of hospitalization, pain during the first postoperative 24 hours (according to a 0-10 visual analogue scale), need for analgesics, and intraoperative and postoperative adverse events. At 6 weeks and 6 months after surgery, patients underwent a physical examination according to Pelvic Organ Prolapse Quantitative measurements, to assess the anatomical success of the surgery. The Pelvic Floor Distress Inventory-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual-12 questionnaires were administered prior to surgery and at 6-month follow-up. The Patient Scar Assessment Questionnaire and the Activity Assessment Scale were administered at 6 weeks and 6 months after the surgery. Exclusion criteria included contraindication to general anesthesia, a history of prior sacrocolpopexy, suspicious adnexal masses, suspicious thickened endometrium, and morbid obesity (body mass index of 40 kg/m or more).

RESULTS

The mean age of the patients was 58.4 years. More than half of the patients (54%) had stage III prolapse. Mean total operative times were 181.3 ± 32.6 and 157.5 ± 42 minutes for robotic laparoendoscopic single-site and multi-port robotic sacrocolpopexy, respectively; the difference was 23.8 minutes (95% confidence interval, 4.2-43.4, P = .018). The mean differences in duration between the procedures were as follows: 29.8 minutes, 95% confidence interval, 9.2-50.4, P = .005 for anesthesia time; 33.1 minutes, 95% confidence interval, 16.5-49.7, P < .0001 for console time; 8.6 minutes, 95% confidence interval, 1.1-16.3, P = .025 for supracervical hysterectomy time; 8.3 minutes, 95% confidence interval, 1.8-14.8, P = 0.03 for mesh suturing and fixation to the promontory; and 4.7 minutes, 95% confidence interval, 1.5-7.7, P = .004 for peritoneum suturing. Statistically significant differences were not observed between the groups in regard to estimated blood loss, intraoperative complications, and demand for analgesics during hospital stay. Quality-of-life parameters were similar. Patients' assessments of their scars were more favorable in the robotic laparoendoscopic single-site group.

CONCLUSION

For sacrocolpopexy, the operative time was longer for the robotic laparoendoscopic single-site than for the multi-port robotic approach. Both approaches are feasible, and short-term outcomes, quality-of-life parameters, and anatomic repair are comparable. Our results are generalizable only to the specific robotic platforms used in the study.

摘要

背景

骶骨阴道固定术是一种常用于修复穹窿部位脱垂的常见手术。将 Y 形补片固定在脱垂的宫颈或阴道上,并悬挂在前纵韧带的骶骨上。除了传统的腹腔镜和多端口机器人途径外,机器人腹腔镜单部位方法已经成为一种可行、可行且广泛适用的微创方法来进行骶骨阴道固定术。

目的

比较机器人腹腔镜单部位和多端口机器人骶骨阴道固定术治疗子宫阴道或阴道穹窿脱垂的女性。

材料和方法

在这项单中心随机对照试验中,从 2017 年 8 月至 2018 年 11 月,70 名盆腔器官脱垂定量分期 2-4 期的女性被随机分配接受机器人腹腔镜单部位或多端口机器人方法进行骶骨阴道固定术。每组 35 名女性中,有 32 名接受了骶骨阴道固定术。手术时间是该试验的主要结果。次要结果包括术中出血、住院时间、术后 24 小时内的疼痛(根据 0-10 视觉模拟量表)、对镇痛药的需求以及术中及术后不良事件。术后 6 周和 6 个月,根据盆腔器官脱垂定量测量进行体格检查,以评估手术的解剖学成功。在术前和 6 个月随访时,使用盆腔器官窘迫问卷-20 和盆腔器官脱垂/尿失禁性问卷-12 进行问卷调查。术后 6 周和 6 个月时,使用患者疤痕评估问卷和活动评估量表进行评估。排除标准包括全身麻醉禁忌、既往骶骨阴道固定术史、可疑附件肿块、可疑增厚子宫内膜和病态肥胖(体重指数 40kg/m 或以上)。

结果

患者的平均年龄为 58.4 岁。超过一半的患者(54%)患有 III 期脱垂。机器人腹腔镜单部位和多端口机器人骶骨阴道固定术的总手术时间分别为 181.3±32.6 分钟和 157.5±42 分钟;差异为 23.8 分钟(95%置信区间,4.2-43.4,P=0.018)。手术时间之间的平均差异如下:麻醉时间 29.8 分钟,95%置信区间,9.2-50.4,P=0.005;控制台时间 33.1 分钟,95%置信区间,16.5-49.7,P<0.0001;宫颈切除时间 8.6 分钟,95%置信区间,1.1-16.3,P=0.025;补片缝合和固定到穹窿的时间为 8.3 分钟,95%置信区间,1.8-14.8,P=0.03;腹膜缝合时间为 4.7 分钟,95%置信区间,1.5-7.7,P=0.004。两组间术中出血量、术中并发症和住院期间对镇痛药的需求无统计学差异。生活质量参数相似。患者对机器人腹腔镜单部位组的疤痕评估更为有利。

结论

对于骶骨阴道固定术,机器人腹腔镜单部位手术的手术时间长于多端口机器人手术。两种方法均可行,短期结果、生活质量参数和解剖修复结果相当。我们的研究结果仅适用于研究中使用的特定机器人平台。

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