经阴道自然腔道单孔腹腔镜行卵巢囊肿剥除术的可行性和安全性研究

Feasibility and safety of transvaginal natural orifice transluminal endoscopic surgery for ovarian cystectomy

目的探讨经阴道自然腔道单孔腹腔镜(transvaginal natural orific transluminal endoscopic surgery,vNOTES)行卵巢囊肿剥除术的可行性和安全性。方法该研究是基于“经阴道自然腔道单孔腹腔镜手术(vNOTES)在妇产科良性附件手术中应用的有效性和安全性研究”(临床试验注册号:ChiCTR2100052223)的亚组分析。研究人员于北京医院妇科进行的一项1∶1随机、单中心、非劣效性平行对照试验,非劣效性界值为10%,选取2019年8月至2022年2月在北京医院行卵巢囊肿剥除术的18~50岁符合研究纳入标准的患者,采用分层区组随机方法,根据手术范围分层后,利用随机数字表将纳入的受试者按1∶1随机分入观察组和对照组。观察组通过vNOTES行卵巢囊肿剥除术,对照组通过传统多孔腹腔镜行卵巢囊肿剥除术。主要评价指标为两组通过随机分配的术式完成卵巢囊肿剥除术而未转行其他术式完成手术的比率。次要评价指标为手术时间、术中出血量、术后并发症、术后24 h及1周内视觉模拟(VAS)疼痛评分、术后健康情况和性功能评分等相关数据。结果共有94例受试者纳入研究,观察组和对照组各47例,所有受试者均按照分配的手术方式顺利完成手术,未在术中转行其他手术术式。对手术成功率进行敏感性分析,假设观察组有1例在手术过程中改用其他手术方式,对照组手术全部成功,双侧比例差异的95%置信上限估计为6%,低于10%非劣效性界值。两组受试者术前基线情况、手术时间、术中出血量、健康状况评分及性功能评估差异均无统计学意义(P>0.05)。观察组术后排气时间低于对照组,差异有统计学意义[(18.9±7.7)h vs.(38.2±14.0)h,(P<0.05)];观察组术后7d内每天的VAS疼痛评分均明显低于对照组,差异有统计学意义(P<0.05)。观察组术后3个月、6个月健康情况评分[分别为(129.7±9.1)分和(127.6±10.2)分]较对照组[分别为(119.4±9.8)分和(119.7±10.8)分]高,性功能评估评分[分别为(23.2±8.4)分和(23.2±7.5)分]亦较对照组[分别为(11.1±10.7)分和(10.3±10.7)分]高,差异均有统计学意义(P<0.05)。结论经阴道自然腔道单孔腹腔镜进行卵巢囊肿剥除术是安全可行的,具有疼痛轻、腹部无任何创口、身体恢复快等独特的优势,是一种微创的手术方式,可作为卵巢良性肿瘤治疗的手术方式。

Objective To investigate the feasibility and safety of transvaginal natural orifice transluminal endoscopic surgery(vNOTES)for benign ovarian cystectomy.Methods This study was a subgroup analysis of“Efficacy and Safety Study of Transvaginal Single-port Laparoscopic Surgery(v NOTES)in Benign Gynecological Adnexal Surgery”(Clinical Trial Registry:ChiCTR2100052223).A parallel study of1∶1 single-center non-inferior randomized controlled trial with a non-inferiority cut-off value of 10%was conducted in Beijing Hospital.Women who aged 18-50years undergoing surgery for benign lesions from 1August 2019 to 1 February 2022 were enrolled.This study used a stratified block randomized method.All of the included patients were grouped 1∶1 by random table method in each stratum based on the extent of surgical resection.The included subjects were allocated to the observation group receiving vNOTES and the control group receiving conventional laparoscopy for ovarian cystectomy.The primary outcome evaluation indicator was the rate of completion of ovarian cystectomy without switching to other procedures in the two groups.Secondary evaluation indicators were operation time,intraoperative blood loss,postoperative complications,visual analog pain scor(eVAS)within 24 hours and one week after operation,postoperative sexual function score and other related data.Results There were 94 patients in total,including 47 in the observation group and 47 in the control group.All patients successfully completed the operation according to the assigned operation method,and were not transferred to other surgical methods during the operation.Sensitivity analysis was performed on the surgical success rate,assuming that 1 case in the observation group was switched to other surgical methods during the operation,and all the operations in the control group were successful,the 95%upper limit of confidence for the difference in the two-sided proportions was estimated at 6%,which was below the10%noninferiority cut-off value.There were no significant differences in preoperative baseline conditions,operation time,intraoperative blood loss,health status score or sexual function evaluation between the two groups(P>0.05).The postoperative exhaust time in the observation group were lower than those in the control group[(18.9±7.7)h vs.(38.2±14.0)h],with significant differences(P<0.05).The VAS pain score of the observation group was significantly lower than that of the control group every day within 7 days after surgery,and the difference was statistically significant(P<0.05).The health condition scores at 3 and 6 months after operation in the observation group[(129.7±9.1)and(127.6±10.2)points,respectively]were higher than those in the control group[(119.4±9.8)and(119.7±10.8)points,respectively],and the sexual function evaluation scores[(23.2±8.4)and(23.2±7.5)points,respectively]were also higher than those in the control group[(11.1±10.7)and(10.3±10.7)scores,respectively],with statistically significant differences(P<0.05).Conclusion Transvaginal natural orifice transluminal endoscopic surgery for ovarian cystectomy is safe and feasible,with unique advantages such as less pain,less scarring,and faster recovery.It is a more minimally invasive surgical method and can be used as a treatment for benign ovarian tumors.