Department of obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Gansu Provincial Maternal and Child Health Center Gansu Provincial Central Hospital, Lanzhou, Gansu, P.R. China.
BMC Womens Health. 2024 Jul 5;24(1):390. doi: 10.1186/s12905-024-03226-5.
There is a scarcity of prospective clinical research evidence regarding the utilization of transvaginal natural orifice translumenal endoscopic surgery (vNOTES) as a treatment option for ovarian cysts. The objective of this study was to assess the feasibility and safety of employing vNOTES for the management of ovarian cysts.
Our study included women between the ages of 18 and 70 who intended to undergo surgical intervention for benign lesions. Stratified blocked randomization was employed to allocate participants into groups. The main objective was to assess whether the assigned group adhered to the recommended surgical technique for ovarian cystectomy or adnexectomy, without any deviation to alternative surgical methods.
A total of 196 patients were included in the study, with all surgeries in each group being conducted according to the assigned procedures. Among them, the ovarian cystectomy layer included 58 cases in the vNOTES group and 58 cases in the conventional laparoscopy (CL) groups. The adnexectomy layer included 40 cases in the vNOTES group and 40 cases in the CL group. Utilizing a sensitivity analysis, the two-sided 95% lower confidence limit was determined to be 5.5% for the disparity in proportions between the vNOTES groups and CL groups. These lower limits fell below the predetermined non-inferiority margin of 10%.
The study findings demonstrate that vNOTES was not inferior to CL in terms of adnexectomy or ovarian cystectomy. vNOTES can be considered a more minimally invasive surgical approach, as it results in reduced postoperative pain, faster recovery, and absence of visible incisions. Overall, vNOTES proves to be a safe, feasible, and less invasive treatment option.
This study retrospectively registered with the China Clinical Trial Registry with the registration number ChiCTR2100052223(22-10-2021).
关于经阴道自然腔道内镜手术（vNOTES）作为卵巢囊肿治疗选择的应用，前瞻性临床研究证据稀缺。本研究旨在评估 vNOTES 用于管理卵巢囊肿的可行性和安全性。
我们的研究纳入了年龄在 18 岁至 70 岁之间、计划接受良性病变手术干预的女性。采用分层区组随机化将参与者分配到组中。主要目的是评估分配组是否遵守卵巢囊肿切除术或附件切除术的推荐手术技术，没有任何向替代手术方法的偏差。
共有 196 例患者纳入研究，每组的所有手术均按指定程序进行。其中，vNOTES 组卵巢囊肿切除术层有 58 例，传统腹腔镜（CL）组有 58 例。vNOTES 组附件切除术层有 40 例，CL 组有 40 例。通过敏感性分析，双侧 95%置信区间下限确定为 vNOTES 组和 CL 组之间比例差异的 5.5%。这些下限低于预定的非劣效性边界 10%。
研究结果表明，vNOTES 在附件切除术或卵巢囊肿切除术中不劣于 CL。vNOTES 可以被认为是一种更微创的手术方法，因为它会导致术后疼痛减轻、恢复更快且没有可见的切口。总体而言，vNOTES 是一种安全、可行且微创的治疗选择。
本研究在中国临床试验注册中心以注册号 ChiCTR2100052223（2021 年 10 月 20 日）进行了回顾性注册。
