背景:关于将经阴道自然腔道内镜手术(vNOTES)作为卵巢囊肿的治疗选择,缺乏前瞻性临床研究证据。这项研究的目的是评估使用vNOTES治疗卵巢囊肿的可行性和安全性。
方法:我们的研究包括18至70岁的女性,她们打算接受良性病变的手术治疗。采用分层阻断随机化将参与者分组。主要目的是评估指定组是否遵守推荐的卵巢囊肿切除术或附件切除术的手术技术,对替代手术方法没有任何偏差。
结果:共有196名患者被纳入研究,每组的所有手术都按照指定的程序进行。其中,卵巢囊肿切除层为vNOTES组58例,传统腹腔镜(CL)组58例。附件层包括vNOTES组40例和CL组40例。利用敏感性分析,对于vNOTES组和CL组之间的比例差异,双侧95%置信下限确定为5.5%.这些下限低于10%的预定非劣效性界限。
结论:研究结果表明,在附件切除术或卵巢囊肿切除术方面,vNOTES不亚于CL。vNOTES可以被认为是一种更微创的手术方法,因为它减少了术后疼痛,更快的恢复,没有可见的切口。总的来说,VNOTES被证明是安全的,可行,和侵入性较小的治疗选择。
背景:本研究在中国临床试验注册中心进行了回顾性注册,注册号为ChiCTR2100052223(22-10-2021)。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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%.
CONCLUSIONS: 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.
BACKGROUND: This study retrospectively registered with the China Clinical Trial Registry with the registration number ChiCTR2100052223(22-10-2021).