Evaluating Safety and Effectiveness of a Fully Visualized Vaginal Access Platform in Transvaginal Hysterectomy for Uterine Fibroids

What this Trial Is About

Researchers are evaluating a new technique for hysterectomy called the vNOTES method in patients with uterine fibroids who need total hysterectomy. This study compares a new fully visualized vaginal access platform with the traditional vNOTES approach to assess if the new method is effective and safe. The trial is conducted as a multicenter, prospective randomized controlled study to carefully measure surgical outcomes and patient recovery. Participants are randomly assigned to either the experimental group using the multi-channel vaginal sealing instrument with full visualization or the control group using the traditional method. The new platform is inserted through the vagina, inflates with air pressure to expose the vaginal dome fully, and completes the hysterectomy under laparoscopic guidance. The traditional approach involves incising the vaginal fornix and part of cervical ligaments to establish the surgical platform. During the study, researchers will record the success of establishing the surgical platform, time taken, bleeding amounts, anesthesia indicators, and surgical complications. Follow-up includes measuring hospital stay length, pain scores, and quality of life for six months post-surgery. Vital signs like heart rate and blood pressure are monitored during surgery. The study aims to provide detailed safety and efficacy data over the entire surgical and recovery period.

Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy