Patients with clinical International Federation of Gynecology and Obstetrics (FIGO) stage II endometrial adenocarcinoma, IB1–IIA1 cervical carcinoma, and IB2–IIB cervical cancer after neoadjuvant chemotherapy (NACT) with clinical response ≥50% were enrolled to perform RSSRH plus PL.

All patients were evaluated preoperatively through: anamnesis, physical examination, vaginal-pelvic examination, chest X-ray, trans-vaginal ultrasound scan, and pelvic magnetic resonance imaging (MRI) scan. An Eastern Cooperative Oncology Group performance status of 2 or less, an adequate renal, hepatic, and cardiac function, and an adequate granulocyte and platelet count ≥2,000/mL and ≥100,000/mL, respectively were required for this surgery. Lymph node and/or adnexal involvement at computed tomography/MRI, uterine size ≥12 weeks of pregnancy and the impossibility to sustain a steep Trendelenburg position were considered the exclusion criteria for the RSSRH. The da Vinci Si Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) was used by the same surgical team consisting of the primary surgeon (E.V.), the bedside assistant (G.C.) and a robotics-dedicated scrub technician and circulating nurse.

The following data were collected prospectively: clinical patient characteristics, pathologic characteristics (tumor stage and grade, surgical margins, status and number of removed pelvic lymph nodes, length of dissected parametrial tissue, and vagina), operative time (considering surgical incision to skin closure), estimated blood loss, blood transfusions (if hemoglobin value was <7 g/dL), length of hospitalization, post-operative complications divided into early (in the first 30 days after surgery) and late complications (more than 30 days after surgery). Common Terminology Criteria for Adverse Events (CTCAEs) version 4.0 was used to define complications [11]. Moreover, type of adjuvant therapy (radiotherapy and/or chemotherapy), median follow up in one month and recurrence were recovered. Adjuvant therapy was tailored to the pathologic findings at primary operation after multidisciplinary tumor board (gynecologic oncology, pathology, radiation oncology, medical oncology) discussion. Treatment was based on the results of prospective, randomized clinical trials and National Comprehensive Cancer Network Guidelines [12]. All the information concerning the follow up was collected over telephone calls to the patients.

The study was approved by our institutional review board (#0011950/16). All the patients enrolled completed an informed consent for surgery and preoperative evaluations in accordance with the ethical principles of the local and the international regulations (declaration of Helsinki) [13].

All patients were administered antibiotic prophylaxis (Augmentin 2.2 g intravenously; GlaxoSmithKline, Research Triangle Park, NC, USA) and perioperative low molecular weight enoxaparin (Lovenox 40 mg/24 hr subcutaneously; Sanofi-Aventis U.S. LLC, Bridgewater, NJ, USA). The vaginal cavity was cleansed with povidone iodine solution and a Foley catheter was placed in the bladder. No uterus manipulator devices were used, but the cervix was closed with a modified tenaculum called “simple nebs arising incision landmark” (SNAIL^®) [14]. A medical grade silicone balloon, named colpo-pneumo occluder (CooperSurgical, Inc., Trumbull, CT, USA) was also placed in the vagina in order to preserve an adequate pneumoperitoneum during colpotomy. In addition, intraoperative lower extremity sequential compression devices for venous thrombosis prophylaxis were used. All procedures were performed under general endotracheal anesthesia.

A 2 cm long incision over the lower rim of the umbilicus, down to the level of the fascia was made after lubrication of the Single-Site™ port (Intuitive Surgical Inc.) by dipping it in a sterile solution (e.g., saline or water). Using an atraumatic clamp, the Single-Site™ port was grasped just above the lower rim. The leading edge of the folded port was inserted into the incision with a downward motion, while counter-traction was provided by retractors within the incision. Insufflation to reach a pneumoperitoneum of approximately 12 mmHg started. Next, the table was placed in the Trendelenburg position (30 degrees). The da Vinci Si 8.5 mm 30-degrees endoscope was inserted vertically and used during the whole course of surgery. Subsequently, a 5×250 mm curved cannula (Arm 2) was lubricated and inserted through the designated lumen while the external rim of the port was held by the assistant to avoid displacement. The cannula was guided near the uterus and then held still to allow docking. This was done by holding the cannula still in one hand while the other hand brings and mounts the arm to the second 5×250 mm curved cannula (Arm 1). Finally, the instruments were introduced: a monopolar spatula or scissors, for the lymphadenectomy step, on Arm 2 and a bipolar Maryland on Arm 1 to perform right lymphadenectomy and reverse for left lymphadenectomy (Fig. 1). The assistant's 5 mm accessory cannula, with which the assistant holds and moves either a suction/irrigator or a 5-mm endo-clip instrument, was inserted in last. A careful inspection of the entire abdominal cavity was performed with the robotic endoscope in order to identify any suspicious peritoneal lesions that would exclude the patient from having the procedure completed by robotic technique. Moreover, peritoneal washing was routinely performed.

A radical type B1 or C1 hysterectomy plus PL, according to Querleu and Morrow classification [15], was performed beginning from surgical preparation of the retroperitoneal spaces: Paravesical space, Lasko's fossa and medial pararectal fossa or “Okabayashi's pararectal space,” In case of positive pelvic nodes at definitive examination, after adequate counseling, a laparoscopic single port aortic lymphadenectomy was performed 3 weeks after the RSSRH until the left renal vein. In all patients, the lymph nodes were placed in the endobag and were extracted throughout the vagina with a surgical specimen. The vaginal vault was closed with single stitches using the vaginal way and each layer of the access port was sutured separately. Starting from the end of surgery for the first 24 hours, analgesic therapy with tramadol 100 mg plus ketorolac 60 mg was administered by continuous infusion. Paracetamol 1,000 mg was administered only on patient's demand. Visual analog scale was used for pain assessment. In all cases the urine catheter was removed 12 hours after B1 radical surgery and 3 days after operation after C1. In these last cases, an intermittent self-catheter was used for voiding until the residual urine volume was less than 100 mL. Criteria considered for discharge were physiologic recovery of bladder and rectal function and no pain.

A total of twenty patients underwent RSSRH plus PL from April 2014 to November 2016. Patient characteristics are summarized in Table 1. Four patients had undergone previous abdominal surgical procedures. A total of 17 patients underwent type C1 RSSRH and 3 patients type B1. A PL was performed in all cases. No conversion to laparoscopy or laparotomy was needed.

The median operation time skin-to-skin was 190 minutes (range, 90–310 minutes) and no additional assistant port was necessary. The median blood loss was 75 mL (range, 20–700 mL), no patients required intraoperative, nor postoperative blood transfusions. The median length of dissected parametria was 20 mm (range, 10–25 mm) for the right parametrium and 15 mm (range, 10–35 mm) for the left parametrium and 20 mm (range, 10–50 mm). The median number of pelvic lymph nodes removed was 16 (range, 5–27) and only in one case with complete clinical response after NACT in locally advanced cervical cancer (LACC), 2 nodes were found positive for metastasis. No major intraoperative complications were observed in our cohort (Table 2).

We reported the following early postoperative complications in 4 patients (20%): one intestinal perforation, one pelvic abscess, and one dehiscence of the vaginal vault, respectively on the third, the fifth and on the twenty-first postoperative day and one excessive lymphorrhea. The following procedures: a laparotomy in the first case, a laparoscopy in the second one and a vaginal suture were necessary to solve the complications, lymphorrhea resolved spontaneously in one week. No late post-operative complications were reported. The median hospital stay was 6 days (range, 4–16 days) (Table 3).

Clinical follow-up took place through physical and vaginal-pelvic examinations every 3 months for the first 2 years after treatment. Adjuvant treatment was performed in 10 patients (50%). Radio-chemotherapy was performed in 2 FIGO stage II EC, in 2 patients with early cervical cancer (ECC) for microscopical parametrial involvement and in one LACC after NACT for nodal involvement. The third patient with EC underwent only adjuvant brachytherapy because cervical involvement was excluded at the final pathologic exam. Four LACC after NACT patients underwent adjuvant radiotherapy for macroscopic residual disease, grade 3, lymph vascular space involvement.

Currently, with a median follow-up of 24 months (range, 5–38 months) 18 patients are alive with no evidence of disease. One patient with LACC and complete pathological response after NACT died after 2 months for brain and spinal cord metastasis and another patient with clinical ECC FIGO stage IB1 but with initial parametrial involvement died after 20 months for distant metastasis (Table 4).