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Study Objective Determine the feasibility of a transvaginal single-port robotic system for gynecologic surgical procedures Design Three-stage trials using animal, cadaveric, and human models. Setting The animal trials were performed in a certified animal center. Cadaveric procedures were carried out in a cadaver laboratory. Surgery on humans were performed in hospitals. Patients or Participants Human patients who required a gynecologic procedure were given the option of traditional laparoscopy or single-port transvaginal surgery. Twenty-two patients were enrolled in the study and all 22 completed it. There were 10 adnexal procedures, ranging from salpingectomy to ovarian cystectomy to salpingo-oophorectomy, and 12 total hysterectomies. Interventions A new robotic system was inserted through the posterior vaginal fornix, first in a sheep model, where 17 oophorectomies, 17 salpingectomies, 18 tubal sterilizations and 15 hysterectomies were performed for a total of 67 procedures. Next, cadavers were utilized to perform 15 transvaginal oophorectomies, 15 salpingectomies, 18 sterilization procedures, and 12 total hysterectomies. Finally, single-incision, transvaginal surgery was performed on 22 human subjects - 10 adnexectomies and 12 vaginal hysterectomies. Immediate postoperative course as well as three-month follow-up was carried out in the human participants. Measurements and Main Results The patients were assessed for standard intraoperative as well as postoperative parameters, including operative time, blood loss, and complications. There were no intraoperative or postoperative complications, nor any significant problems encountered at the three-month follow-up. Conclusion Vaginal surgery is recommended as the surgical approach of choice for hysterectomy by the American College of Obstetricians and Gynecologists. However, it remains the route least utilized by practitioners because of technical challenges, ranging from difficulty in accessing the peritoneal cavity to a restricted visualization of abdominal and pelvic contents. A new robotic system has been developed that facilitates entry through a single vaginal incision under direct vision, and then allows 360 degree optics of the entire abdomen and pelvis. |
