| Popis: |
Study Objective When feasible, vaginal hysterectomy has been shown to be the safest and most cost-effective route to remove the uterus compared to abdominal, laparoscopic or robotic techniques. However, in the US, vaginal hysterectomy is performed in only 20% of cases. This study evaluates the safety and feasibility of a novel humanoid shaped robot assisted surgical system for transvaginal laparoscopic hysterectomy. Design A multi-center, single arm, prospective study of robotic transvaginal laparoscopic hysterectomy in women with nonmalignant indications. Setting The surgical-gynecologic services of participating hospitals. Patients or Participants 30 eligible female patients aged was 57.2 years, BMI 18 to 40 kg/m2. Interventions Total transvaginal laparoscopic hysterectomy with salpingectomy or salpingo-oophorectomy performed with a novel robotic system. Measurements and Main Results The transvaginal robotic system performed as intended and all procedures were completed successfully with no conversions to open or laparoscopic surgery. No intraoperative complications, transfusion, bladder or rectal injuries were observed and no robotic system malfunctions or other device-related deficiencies were reported. The procedures had an average time of 57 minutes (range: 24 to 88 min) with the estimated blood loss for 80% of subjects less than 100ml (24/30), 13% between 100-200ml (4/30) and 7% at 400ml (2/30). All patients’ vaginal cuff and point of entry healed as expected at the six weeks follow up visit. Conclusion The positive results of this clinical series show this new approach using a humanoid shaped robot assisted surgical system to be both a safe and effective tool for laparoscopic transvaginal hysterectomy. |
