Abstract
Background
To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures.
Methods
Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included.
Results
Median age was 52 years (range 19–79 years), and median BMI was 23.7 (range 17.3–34.0 kg/m2). Sixty-two patients (32.5 %) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7 %) myomectomy (Group B), 46 patients (31.5 %) total hysterectomy (Group C), and 34 (23.3 %) endometrial cancer staging (Group D). Median docking time was 7 min (range 3–36). Median OT was 35 min (range 17–145) in the Group A, 40 min (range 10–50) in the Group B, 133 min (range 58–320) in the Group C, and 160 min (range 69–290) in the Group D. Reduction in OT over the study period for hysterectomy (p < 0.001) and adnexal surgery (p < 0.002) was observed. We registered two laparoscopic conversion (3.2 %) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9 %) laparoscopic and two (5.8 %) laparotomic conversions. One patient (2.17 %) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding.
Conclusions
We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.
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Disclosures
Francesco Fanfani, Giorgia Monterossi, Anna Fagotti, Cristiano Rossitto, Salvatore Gueli Alletti, Barbara Costantini, Valerio Gallotta, Luigi Selvaggi, Stefano Restaino, and Giovanni Scambia have no conflict of interest or financial ties to disclose. The TELELAP ALF-X was offered by the SOFAR s.p.a. for the study period.
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Fanfani, F., Monterossi, G., Fagotti, A. et al. The new robotic TELELAP ALF-X in gynecological surgery: single-center experience. Surg Endosc 30, 215–221 (2016). https://doi.org/10.1007/s00464-015-4187-9
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DOI: https://doi.org/10.1007/s00464-015-4187-9