Comparing Vaginal Natural Orifice Transluminal Endoscopic Surgery and Laparoscopic Hysterectomy for Large Uterus in Benign Conditions

What this Trial Is About

This research evaluates two types of minimally invasive hysterectomy surgeries for women with large benign uteri, which are uteri weighing more than 280 grams. Hysterectomy is a common gynecological surgery performed via laparotomy, laparoscopy, or the vaginal route. The study aims to compare the new vaginal natural orifice transluminal endoscopic system vNOTES approach with the standard laparoscopic hysterectomy, focusing on safety and complications for large uteri, as current data on optimal approaches are limited and inconsistent. The study compares two surgical methods laparoscopic hysterectomy, performed in a standardized way with or without robotic assistance, and vNOTES hysterectomy, which uses a vaginal approach with an endoscopic system. The vNOTES method offers the advantage of combining vaginal and endoscopic surgery, potentially reducing pain, complications, and hospital stay without scarring. Each participant will undergo one of these procedures according to random assignment. Participants will be women over 18 years old with large benign uteri who agree to participate. Researchers will monitor patients for complications from surgery through six weeks post-operation, as well as any need to switch to another surgical method during the procedure. The study includes preoperative consultations and follow-up visits to assess safety and recovery. Participation is expected to last from surgery through at least six weeks of post-surgical monitoring.

Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy