Fanfani Francesco, Restaino Stefano, Gueli Alletti Salvatore, Fagotti Anna, Monterossi Giorgia, Rossitto Cristiano, Costantini Barbara, Scambia Giovanni
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
Department of Obstetrics and Gynecology, Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", University of Trieste, Trieste, Italy.
J Minim Invasive Gynecol. 2015 Sep-Oct;22(6):1011-7. doi: 10.1016/j.jmig.2015.05.004. Epub 2015 May 14.
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).
Phase II study (Canadian Task Force II-2).
Catholic University of the Sacred Heart, Rome, Italy.
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).
Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy.
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.
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.
展示全TELELAP ALF-X子宫切除术(意大利米兰特雷扎诺罗萨的索法尔股份公司,ALF-X手术机器人部门)的安全性、可行性及围手术期结果。
II期研究(加拿大工作组II-2)。
意大利罗马的圣心天主教大学。
2013年10月至2014年5月,80名女性接受了全TELELAP ALF-X子宫切除术。根据手术程序,研究人群分为2组:全子宫切除术±双侧输卵管卵巢切除术(第1组)和接受盆腔淋巴结清扫术分期的子宫内膜癌患者(第2组)。
全TELELAP ALF-X子宫切除术±双侧输卵管卵巢切除术,伴或不伴盆腔淋巴结清扫术。
中位年龄为51岁(范围48 - 79岁),中位体重指数为24 kg/m²(范围17.3 - 34.2)。45名患者(56.2%)曾接受过手术。第1组中位手术时间为140分钟(范围58 - 320分钟),第2组为197分钟(范围129 - 290分钟)(p < 0.001)。中位对接时间为8分钟(范围3 - 25分钟)。在研究期间,观察到手术时间有显著缩短趋势。93.7%的病例手术成功完成,未转为其他术式。我们观察到2例(2.5%)术中并发症,3例(3.7%)转为标准腹腔镜手术,2例(2.5%)转为开腹手术。中位出院时间为2天(范围1 - 5天)。1例患者(1.2%)在术后早期再次入院。
随着新技术的发展,对与患者相关的结局、使用情况、成本以及微创子宫切除术的可及性进行严格评估仍应是首要任务。尽管我们的系列病例数量相对较少,但我们展示了全TELELAP ALF-X子宫切除术治疗良性和恶性疾病的可行性和安全性。