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Transvaginal natural orifice transluminal endoscopic surgery for tubal ectopic pregnancy(vNOTESTEP): a protocol for a
Xinyu Xiao1, Tianjiao Liu1, Xin Li2
1Department of Gynecology of Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 1617, Riyue Avenue, Chengdu, Sichuan, 610091, People's Republic of China.
Background:
Tubal ectopic pregnancy is a life-threatening condition in early pregnancy. Minimally invasive laparoscopic surgery is increasingly used for the treatment of this disease. Retrospective studies suggest that Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) offers lower perioperative complications, faster recovery, and better cosmetic outcomes compared to other approaches. However, the lack of comprehensive perioperative and long-term postoperative data limits its widespread adoption in gynecology.
Methods:
The vNOTESTEP study is a randomized controlled trial (RCT) enrolling 72 patients requiring laparoendoscopic surgery for tubal ectopic pregnancy. After obtaining informed consent, preoperative assessments will be conducted. Following randomization, salpingectomy will be performed using either vNOTES or TU-LESS approach. The postoperative assessment and a structured 5-year follow-up, including eight visits, will be conducted. Baseline sociodemographic and clinical data will be collected from the Hospital Information System and patient interviews. Outcomes will be assessed perioperatively and postoperatively at designated time points (1st, 2nd, and 3rd postoperative day; 1st, 3rd, and 6th month; 1st-5th year). Key long-term outcomes include sexual function, pregnancy, vaginal delivery, and incisional hernia.
Discussion:
This RCT aims to provide robust clinical evidence on the perioperative and long-term outcomes of vNOTES versus TU-LESS for tubal ectopic pregnancy, focusing on key reproductive and surgical outcomes. The study seeks to refine patient selection criteria and contribute to guideline development for gynecologic vNOTES.
Trial Registration Number:
ChiCTR2400082909 (registered on April 10th, 2024).
