Francesco Fanfani1, Stefano Restaino2, Salvatore Gueli Alletti3, Anna Fagotti4, Giorgia Monterossi3, Cristiano Rossitto3, Barbara Costantini3, Giovanni Scambia3. 1. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. Electronic address: francesco.fanfani@rm.unicatt.it. 2. Department of Obstetrics and Gynecology, Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", University of Trieste, Trieste, Italy. 3. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. 4. Minimally Invasive Gynecology, St. Maria Hospital, University of Perugia, Terni, Italy.
Abstract
STUDY OBJECTIVE: To show the safety, feasibility, and perioperative outcomes of total TELELAP ALF-X hysterectomy (SOFAR S.p.A., ALF-X Surgical Robotics Department, Trezzano Rosa, Milan, Italy). DESIGN: Phase II study (Canadian Task Force II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: From October 2013 to May 2014, 80 women underwent total TELELAP ALF-X hysterectomy. The study population was divided into 2 groups according to surgical procedures: total hysterectomy ± bilateral salpingo-oophorectomy (group 1) and endometrial cancer patients staged with pelvic lymphadenectomy (group 2). INTERVENTIONS: Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: The median age was 51 years (range, 48-79), and the median body mass index was 24 kg/m(2) (range, 17.3-34.2). Forty-five patients (56.2%) had previous surgery. The median operative time was 140 minutes (range, 58-320) in group 1 and 197 minutes (range, 129-290) in group 2 (p < .001). The median docking time was 8 minutes (range, 3-25). During the study period, a significant trend in operative time reduction was observed. Procedures were successfully performed without conversion in 93.7% of cases. We observed 2 (2.5%) intraoperative complications, 3 (3.7%) conversions to standard laparoscopy, and 2 (2.5%) to laparotomy. The median time to discharge was 2 days (range, 1-5). One patient (1.2%) was readmitted in the early postoperative period. CONCLUSION: As new technology evolves, critical appraisal of patient-related outcomes, use, cost, and access to minimally invasive hysterectomy must remain a priority. Despite the relative small number of our series, we showed the feasibility and safety of total TELELAP ALF-X hysterectomy for benign and malignant disease.
STUDY OBJECTIVE: To show the safety, feasibility, and perioperative outcomes of total TELELAP ALF-X hysterectomy (SOFAR S.p.A., ALF-X Surgical Robotics Department, Trezzano Rosa, Milan, Italy). DESIGN: Phase II study (Canadian Task Force II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: From October 2013 to May 2014, 80 women underwent total TELELAP ALF-X hysterectomy. The study population was divided into 2 groups according to surgical procedures: total hysterectomy ± bilateral salpingo-oophorectomy (group 1) and endometrial cancerpatients staged with pelvic lymphadenectomy (group 2). INTERVENTIONS: Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: The median age was 51 years (range, 48-79), and the median body mass index was 24 kg/m(2) (range, 17.3-34.2). Forty-five patients (56.2%) had previous surgery. The median operative time was 140 minutes (range, 58-320) in group 1 and 197 minutes (range, 129-290) in group 2 (p < .001). The median docking time was 8 minutes (range, 3-25). During the study period, a significant trend in operative time reduction was observed. Procedures were successfully performed without conversion in 93.7% of cases. We observed 2 (2.5%) intraoperative complications, 3 (3.7%) conversions to standard laparoscopy, and 2 (2.5%) to laparotomy. The median time to discharge was 2 days (range, 1-5). One patient (1.2%) was readmitted in the early postoperative period. CONCLUSION: As new technology evolves, critical appraisal of patient-related outcomes, use, cost, and access to minimally invasive hysterectomy must remain a priority. Despite the relative small number of our series, we showed the feasibility and safety of total TELELAP ALF-X hysterectomy for benign and malignant disease.
Authors: Salvatore Gueli Alletti; C Rossitto; S Cianci; E Perrone; S Pizzacalla; G Monterossi; G Vizzielli; S Gidaro; G Scambia Journal: J Robot Surg Date: 2017-06-17