Abstract
Background
Natural orifice transluminal endoscopic surgery (NOTES) is a series of novel and controversial minimally invasive surgical (MIS) approaches. NOTES performed in a transvaginal fashion (vNOTES) reportedly has many advantages over other NOTES approaches and is preferentially used for treating benign gynecologic conditions. However, the lack of detailed, large-scale perioperative and long-term postoperative data to support the feasibility and safety of vNOTES, especially on its impact on patients’ postoperative outcomes, remains contentious and may impede its acceptance in gynecology.
Methods
The Chengdu Longitudinal Cohort Study on vNOTES in Treating Benign Gynecologic Indications (the CLOCKBEGIN study) is a randomized controlled trial (RCT) that will recruit about 3,400 gynecologic patients with benign indications who underwent vNOTES or transumbilical laparoendoscopic single-site surgery for oviduct salpingostomy, tubal ligation, salpingectomy, ovarian cystectomy, adnexectomy, hysterectomy, or myomectomy. 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 CLOCKBEGIN study aims to assess the perioperative and long-term postoperative outcomes of vNOTES in the treatment of major benign gynecologic conditions compared to TU-LESS, focusing on patients’ sexual function, pregnancy, vaginal delivery, and incisional hernia. This large cohort, two-arm, prospective CLOCKBEGIN study, incorporating a comprehensive long-term follow-up strategy and employing a double-blinded randomized RCT design, 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:
ChiCTROOC- 2200059282 (registered on April 28th, 2022)