Salvatore Gueli Alletti

Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial

OBJECTIVE To compare postoperative pain after laparoendoscopic single-site surgery (LESS) approach with conventional multiaccess laparoscopy (LPS). STUDY DESIGN Prospective randomized trial. SETTING University hospital. PATIENT(S) Benign adnexal disease. INTERVENTION(S) Postoperative pain was measured by using the visual analog scale (VAS) at 20 minutes, 2 hours, 4 hours, and 8 hours after surgery. The need for postoperative rescue doses of analgesia was also recorded. MAIN OUTCOME MEASURE(S) Pain after surgery. RESULT(S) A total of 60 patients were enrolled. Within 8 hours, patients who underwent conventional LPS complained of statistically significant greater postoperative pain at VAS evaluation than those undergoing LESS, both at rest and after Valsalva maneuver, with a higher need for rescue analgesia. CONCLUSION(S) LESS provides an advantage over conventional multiaccess LPS in terms of postoperative pain and need for rescue analgesia, with similar perioperative outcomes.

Laparoscopic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study

OBJECTIVE To assess the feasibility of laparoscopic radical surgery in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). DESIGN Prospective phase II study (Canadian Task Force classification II-1). INTERVENTION Patients with LACC (FIGO stage IB2-III) were evaluated for accrual at the Gynecologic Oncology Unit of Catholic University, Rome/Campobasso. Neoadjuvant CT/RT included whole-pelvic irradiation (total dose, 45.0-50.4 Gy) combined with cisplatin and 5-fluorouracil. Objective response to treatment was evaluated according to Response Evaluation Criteria in Solid Tumors criteria. Laparoscopic radical hysterectomy (RH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 to 8 weeks after CT/RT. The feasibility of laparoscopic RH, as well as the rate, pattern, and severity of early and late postoperative complications, were analyzed. RESULTS Between January 2010 and October 2013, a total of 58 patients were enrolled into the study. After CT/RT, 23 patients (39.6%) underwent type B2 RH, 31 (53.4%) underwent type C1 RH, and 4 (6.9%) underwent type C2 RH. Pelvic lymphadenectomy was performed in all cases. Laparoscopic RH was feasible in 55 of 58 cases (feasibility rate, 94.8%). No intraoperative complications were recorded. During the observation period (median, 22 months; range, 5-50 months), there were 28 complications, of which only 21.4% were grade 2 complications and 14.3% were grade 3 complications. As of January 2015, disease recurrence was documented in 4 cases (6.9%). CONCLUSION Total laparoscopic radical surgery is feasible in patients with LACC receiving preoperative CT/RT, providing perioperative outcomes comparable to those registered in early-stage disease.

Telelap ALF-X vs Standard Laparoscopy for the Treatment of Early-Stage Endometrial Cancer: A Single-Institution Retrospective Cohort Study

STUDY OBJECTIVE To compare the surgical and clinical outcomes of patients affected by early-stage endometrial cancer treated using the Telelap ALF-X platform versus conventional laparoscopic surgery. DESIGN Single institution retrospective cohort study (Canadian Task Force classification II-2). SETTING Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy. PATIENTS The study involved 89 patients affected by early-stage endometrial cancer who underwent elective surgical staging between October 2013 and September 2014. Among them, 43 (48.3%) underwent Telelap ALF-X staging (ALF-X group), and 46 (51.7%) underwent conventional laparoscopic staging (laparoscopic group). INTERVENTIONS All selected patients underwent laparoscopic staging with radical hysterectomy (class A sec Querleu-Morrow), bilateral salpingo-oophorectomy, and pelvic lymphadenectomy if required. The 2 surgical groups were further divided into patients who did not require pelvic lymphadenectomy (subgroup 1) and those who underwent pelvic lymphadenectomy (subgroup 2). MEASUREMENTS AND MAIN RESULTS In the ALF-X group, the median operative time was 128 minutes (range, 69-260 minutes) for subgroup 1 and 193 minutes (range, 129-290 minutes) for subgroup 2. In the laparoscopic group, the median operative time was 82 minutes (range, 25-180 minutes) in subgroup 1 and 104 minutes (range, 36-160 minutes) in subgroup 2. The difference in operative time between subgroups was statistically significant in both the ALF-X and laparoscopic groups (p = .000). In subgroup 1 of the ALF-X group, there was 1 conversion to standard laparoscopy (2.3%) and 2 conversions to laparotomy (4.7%) (p = .234). No conversions to laparotomy occurred in the laparoscopic group. Postoperative complications included 1 case of pelvic hematoma (2.3%) in subgroup 1 of the ALF-X group and 1 case of subocclusion and 1 case of pulmonary edema (4.3%) in subgroup 1 of the laparoscopic group. CONCLUSION Based on operative outcomes and complication rates, our results suggest that the Telelap ALF-X approach is feasible and safe for endometrial cancer staging; however, further studies are needed to definitively assess the role of Telelap ALF-X early-stage endometrial cancer staging.

Telelap Alf-X–Assisted Laparoscopy for Ovarian Cyst Enucleation: Report of the First 10 Cases

This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robotic-assisted laparoscopic system. Here we report a series of 10 patients treated using the Telelap ALF-X system in the first clinical application on patients at the Division of Gynecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intraoperative data, including docking time, operative time, estimated blood loss, intraoperative and perioperative complications, and conversion to either standard laparoscopy or laparotomy, were collected. The cysts were removed with an ovary-sparing technique with respect to conservative surgical principles. The median operative time was 46.3 minutes, and patients without postoperative complications were discharged at 1 or 2 days after the procedure. Telelap ALF-X laparoscopic enucleation of benign ovarian cysts with an ovary-sparing technique is feasible, safe, and effective; however, more clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques.

Secondary Laparoscopic Cytoreduction in Recurrent Ovarian Cancer: A Large, Single-Institution Experience

STUDY OBJECTIVE To analyze the feasibility and safety of laparoscopic secondary cytoreductive surgery in a retrospective series of patients with platinum-sensitive recurrent ovarian cancer. DESIGN Retrospective cohort study (Canadian Task Force classification II-2). SETTING Catholic University of the Sacred Heart, Rome, Italy. PATIENTS Between October 2010 and October 2016, 58 patients with recurrent ovarian cancer were selected for a retrospective analysis of data. INTERVENTIONS All patients underwent a laparoscopic secondary cytoreduction with single or multiple procedures. RESULTS The most frequent pattern of recurrence was peritoneal (48.3%); 6 patients (10.3%) experienced parenchymal disease (spleen, n = 5; liver, n = 1), and 24 patients (41.4%) had lymph node recurrence. Complete debulking was achieved in all patients. The median operative time was 204 minutes (range, 55-448 minutes), median estimated blood loss was 70 mL (range, 20-300 mL), and the median length of hospital stay was 4 days (range, 1-21 days). Four patients (6.8%) experienced intraoperative complications. Early postoperative complications were documented in 6 patients (10.3%), but only 1 G3 complication was noted. The median duration of follow-up since secondary cytoreduction was 24 months (range, 9-71 months). Twenty-one patients (36.2%) experienced a second disease relapse. The median progression-free survival (PFS) was 28 months, and the 2-year PFS was 58.7%. Five patients died (8.6%); the 2-year overall survival was 90.7%. CONCLUSIONS For selected patients, laparoscopy is a feasible and safe approach to optimal cytoreduction for patients with recurrent ovarian cancer.

Use of robot-specific resources and operating room times: the case of Telelap Alf-X robotic hysterectomy

The aim of this study was to identify, quantify and evaluate the use of robotic materials and operating theatre times in Telelap ALF‐X robotic hysterectomy.

Learning a new robotic surgical device: Telelap Alf X in gynaecological surgery

To assess the learning curve associated with tele‐assisted surgery.

3 mm Senhance robotic hysterectomy: a step towards future perspectives

In the last two decades, surgical approach for hysterectomy has evolved significantly [1]. On the one hand single-site surgery, minilaparoscopy and the more recent percutaneous approach have led to an increasing search of minimal invasiveness [2]; on the other hand, technology reached the highest expression in robotics [3, 4]. Whereas minimizing laparoscopic access permitted to achieve a further and significant reduction of invasiveness while maintaining surgical adequacy, robotic technology allowed the possibility to overcome common limits of laparoscopic approach extending the advantages of endoscopic surgery to “difficult cases” for whom the only surgical way would have been an extensive laparotomy. Apparently, these two trends deeply diverge from each other. However, technological improvement is constantly redefining the concept of the “minimal” surgical approach. In 2013 the introduction of Telelap ALF-X robotic system (now called SenhanceTM—Transenterix USA) represented a unique innovation in this panorama: robotic technology applied to a pure laparoscopic setting with reusable instruments and 5 mm ancillary trocar [5]. System description Senhance surgical platform is based on three independent robotic arms that are remotely controlled by the Surgeon. From the control unit, named “cockpit”, the surgeon drives the robotic arms by utilizing robotic controls that replicate the laparoscopic manipulators. Immediately below the 3D-HD screen, an infrared sensor, the “eye tracking system”, constantly tracks the surgeon’s eye movement and drives the camera according to the specific point the surgeon is looking at. On each robotic arm, 5 or 3 mm strength and reusable instruments can be hooked and inserted in the peritoneal cavity through standard trocars. A 10-mm balloon trocar is inserted in the umbilicus for the 10-mm 3D-HD camera (Viking System). Once the operative procedure has started, each robotic arm detects the force applied on tissues: these data are processed by the system and translated in “haptic feedback” on the control manipulator. Main characteristics of this innovative technology have been widely investigated in terms of safety and efficacy in gynecological procedures in our Division of Gynecologic Oncology of the Policlinico Agostino Gemelli in Rome [6]. Basing on this premises, looking back to published data in terms of ultra-minimally invasive instrumentation and considering the high versatility of the system, Transenterix recently introduced a totally new CE-marked robotic instrumentation: driven by utilizing surgeons’ requests, a set of 3-mm monopolar reusable robotic instruments was developed to cross the line of both minimally invasive and robotic surgery. Representing an absolute innovation, for the first time in the robotic era, 3 mm instruments are hooked on a robotic platform. From July to September 2017, four patients with indication of hysterectomy with bilateral salpingo-oophorectomy for risk-reducing purpose or premalignant endometrial disease were considered eligible for 3 mm Senhance surgery. IRB approval was obtained and the patients were enrolled after the signing of informed consent. The same surgeon with an experience of more than 100 Senhance procedures performed all surgeries. A standard laparoscopic port placement was adopted for the surgical procedures. * Salvatore Gueli Alletti gueliallettis@gmail.com

Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy

BACKGROUND Vaginal cuff dehiscence following hysterectomy is considered an infrequent but potentially devastating complication. Different possible techniques for cuff closure have been proposed to reduce this threatening adverse event. OBJECTIVE The aim of the present randomized study was to compare laparoscopic and transvaginal suture of the vaginal vault at the end of a total laparoscopic hysterectomy, in terms of incidence of vaginal dehiscence and vaginal cuff complications. Factors associated with vaginal dehiscence were also analyzed. This article presents the results of the interim analysis of the trial. STUDY DESIGN Patients undergoing total laparoscopic hysterectomy for benign indications were randomized at the time of colpotomy to receive vaginal closure through transvaginal vs laparoscopic approach using a 1:1 ratio. Allocation concealment was obtained using a password‐protected randomization database. Monopolar energy for colpotomy was set at 60W. Vaginal closure was performed with a single‐layer running braided and coated 0‐polyglactin suture. In all cases an attempt was performed to include the posterior peritoneum in the suture. Laparoscopic knots were tied intracorporeally. All patients were scheduled for a postoperative follow‐up visit 3 months after surgery, to detect possible vaginal cuff complications. Univariate and multivariable analyses were performed to identify independent predictors of vaginal cuff dehiscence after total laparoscopic hysterectomy. RESULTS After enrollment of 1408 patients, a prespecified interim analysis was conducted. Thirteen (0.9%) women did not undergo the postoperative assessment and were excluded. Baseline characteristics of the 1395 patients included (695 in the transvaginal group and 700 in the laparoscopic group) were similar between groups. Patients in the transvaginal group had a significantly higher incidence of vaginal dehiscence (2.7% vs 1%; odds ratio, 2.78; 95% confidence interval, 1.16–6.63; P = .01) and of any cuff complication (9.8% vs 4.7%; odds ratio, 2.19; 95% confidence interval, 1.43–3.37; P = .0003). Based on these findings, the data monitoring committee recommended that the trial be terminated early. After multivariable analysis, transvaginal closure of the vault was independently associated with a higher incidence of vaginal dehiscence and any vaginal complication; premenopausal status and smoking habit were independently associated with a higher risk of dehiscence. CONCLUSION Laparoscopic closure of the vaginal cuff at the end of total laparoscopic hysterectomy is associated with a significant reduction of vaginal dehiscence, any cuff complication, vaginal bleeding, vaginal cuff hematoma, postoperative infection, need for vaginal resuture, and reintervention.

One-Step Nucleic Acid Amplification (OSNA): A fast molecular test based on CK19 mRNA concentration for assessment of lymph-nodes metastases in early stage endometrial cancer

Introduction The aim of the current study is to evaluate the detection rate of micro- and macro-metastases of the One-Step Nucleic Acid Amplification (OSNA) compared to frozen section examination and subsequent ultra-staging examination in early stage endometrial cancer (EC). Material and methods From March 2016 to June 2016, data of 40 consecutive FIGO stage I EC patients were prospectively collected in an electronic database. The sentinel lymph node mapping was performed in all patients. All mapped nodes were removed and processed. Sentinel lymph nodes were sectioned and alternate sections were respectively examined by OSNA and by frozen section analysis. After frozen section, the residual tissue from each block was processed with step-level sections (each step at 200 micron) including H&E and IHC slides. Results Sentinel lymph nodes mapping was successful in 29 patients (72.5%). In the remaining 11 patients (27.5%), a systematic pelvic lymphadenectomy was performed. OSNA assay sensitivity and specificity were 87.5% and 100% respectively. Positive and negative predictive values were 100% and 99% respectively, with a diagnostic accuracy of 99%. As far as frozen section examination and subsequent ultra-staging analysis was concerned, we reported sensitivity and specificity of 50% and 94.4% respectively; positive and negative predictive values were 14.3% and 99%, respectively, with an accuracy of 93.6%. In one patient, despite negative OSNA and frozen section analysis of the sentinel node, a macro-metastasis in 1 non-sentinel node was found. Conclusions The combination of OSNA procedure with the sentinel lymph node mapping could represent an efficient intra-operative tool for the selection of early-stage EC patients to be submitted to systematic lymphadenectomy.