Abstract
Background
Tubal ectopic pregnancy poses a severe threat to the life of women in early pregnancy. There is an increasing tendency to use minimally invasive laparoscopic surgery to treat tubal ectopic pregnancies. Many retrospective studies have shown that Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) has a lower rate of perioperative complications, faster postoperative recovery, and better cosmetic outcomes when treating tubal ectopic pregnancy. However, the lack of unbiased, detailed perioperative and long-term postoperative data to support the feasibility and safety of vNOTES remains contentious and may impede its acceptance in gynecology.
Methods
The vNOTESTEP study is a randomized controlled trial (RCT) that will recruit about 72 gynecologic patients with indications of laparoendoscopy for treating tubal ectopic pregnancy. Patients will be randomly divided into the vNOTES or transumbilical laparoendoscopic single-site (TU-LESS) group and undergo corresponding approach. After obtaining the participants’ consent, a perioperative assessment and a 5-year postoperative follow-up with eight visits will be conducted. Data collection will be performed perioperatively and postoperatively at designated time points, e.g., 1st, 2nd, and 3rd postoperative day; 1st, 3rd, and 6th month; and 1st, 2nd, 3rd, 4th, and 5th year after the surgery. The baseline information collection will include subjects’ sociodemographics and their health- and gestation-related history obtained from the Hospital Information System and face-to-face interviews. As planned, perioperative and postoperative outcomes will be examined based on intraoperative assessment, in-patient clinical observation, and follow-up WeChat questionnaires or clinic services. Among these outcomes, long-term postoperative results, such as sexual function, pregnancy, vaginal delivery, and incisional hernia, will be the focus.
Discussion
The vNOTESTEP study aims to assess the perioperative and long-term postoperative outcomes of vNOTES in the treatment of tubal ectopic pregnancy compared to TU-LESS, using a RCT design and focusing on patients’ sexual function, pregnancy, vaginal delivery, and incisional hernia. This two-arm, prospective vNOTESTEP study, incorporating a comprehensive long-term follow-up items, has the potential to furnish substantial and robust clinical evidence for refining and establishing guidelines for gynecologic vNOTES procedures. This initiative is also expected to enhance patients' perceptions and acceptance of this innovative minimally invasive surgical approach.
Trial registration number:
ChiCTR2400082909(registered on April 10th, 2024)