Department of Obstetrics and Gynecology, The First Affiliated Hospital (Southwest Hospital), Army Medical University, Chongqing.
Departments of Gynecological Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital l & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen.
Int J Surg. 2023 Oct 1;109(10):2996-3002. doi: 10.1097/JS9.0000000000000551.
Natural orifice transluminal endoscopic surgery (NOTES) is performed increasingly often despite the lack of high-quality evidence confirming its safety, especially for malignant diseases. The aim of this prospective study is to verify that vaginal NOTES (vNOTES) can be performed safely and effectively in early endometrial cancer staging surgery.
This prospective study was conducted in two tertiary hospitals in southern China from January 2021 to May 2022. A total of 120 patients with stage I endometrial cancer were included. vNOTES or multiport laparoscopic staging surgery was selected according to each patient's wishes. The primary outcome was the sentinel lymph node detection rate, analyzed by a noninferiority test. The secondary outcomes were perioperative outcomes.
Among the 120 patients enrolled, 57 underwent vNOTES, and 63 underwent multiport laparoscopy. The patient-specific detection rates of sentinel lymph nodes were 94.73 and 96.82% in the vNOTES and laparoscopy groups, respectively. Additionally, the bilateral detection rates were 82.46 and 84.13%, and the side-specific detection rates were 88.60 and 90.48% in these two groups, respectively. All three detection rates in the vNOTES group were noninferior to those of laparoscopy group at a noninferiority cutoff of -15%. The median operation times of the vNOTES and laparoscopy groups were 132.35 and 138.73 min ( P =0.362), and the median estimated blood loss were 75 and 50 ml ( P =0.096), respectively. No intraoperative complications occurred in either group. The pain scores on the Numerical Rating Scale at both 12 h and 24 h after operation were significantly lower in the vNOTES group ( P <0.001) and the median postoperative hospital stay was significantly shorter in the vNOTES group ( P =0.001).
This study illustrates the potential applicability of vNOTES in gynecological malignancy surgery by demonstrating its safety and effectiveness in endometrial cancer staging. However, its long-term survival outcomes require further exploration.
尽管缺乏高质量证据证实其安全性，尤其是在恶性疾病方面，经自然腔道内镜外科手术（NOTES）的应用仍日益增多。本前瞻性研究旨在验证阴道NOTES（vNOTES）在早期子宫内膜癌分期手术中是否安全有效。
本前瞻性研究于 2021 年 1 月至 2022 年 5 月在我国南方的两家三级医院进行。共纳入 120 例 I 期子宫内膜癌患者。根据每位患者的意愿选择阴道NOTES 或多孔腹腔镜分期手术。主要结局为前哨淋巴结检测率，采用非劣效性检验进行分析。次要结局为围手术期结局。
120 例患者中，57 例行 vNOTES，63 例行多孔腹腔镜手术。vNOTES 和腹腔镜组的患者特定前哨淋巴结检测率分别为 94.73%和 96.82%。此外，双侧检测率分别为 82.46%和 84.13%，侧别特异性检测率分别为 88.60%和 90.48%。vNOTES 组的所有三种检测率在非劣效性截距为-15%时均不劣于腹腔镜组。vNOTES 组和腹腔镜组的中位手术时间分别为 132.35 分钟和 138.73 分钟（ P =0.362），中位估计出血量分别为 75 毫升和 50 毫升（ P =0.096）。两组均无术中并发症。vNOTES 组术后 12 小时和 24 小时的数字评分量表疼痛评分均明显低于腹腔镜组（ P <0.001），vNOTES 组的中位术后住院时间明显短于腹腔镜组（ P =0.001）。
本研究通过证明 vNOTES 在子宫内膜癌分期中的安全性和有效性，说明了其在妇科恶性肿瘤手术中的潜在适用性。然而，其长期生存结局仍需要进一步探索。
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