Laparoscopic sacral hysteropexy versus laparoscopic sacral colpopexy plus supracervical hysterectomy in patients with pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The choice of whether or not to preserve the uterus in the case of patients with urogenital prolapse who undergo sacral colpopexy is still debated. We compared objective and subjective outcomes of laparoscopic sacral hysteropexy (LSHP) and laparoscopic sacral colpopexy with concomitant supracervical hysterectomy (LSCP/SCH) in patients with symptomatic pelvic organ prolapse. METHODS: This is a multicenter retrospective cohort study conducted at the Urogynecology Department of the Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome and at the Diaconesses Croix Saint Simon Hospital of Paris. We collected data of 136 patients; 78 underwent LSHP and 58 underwent LSCP/SCH for pelvic organ prolapse between January 2016 and December 2017. RESULTS: Patients of the two groups had similar preoperative characteristics. All patients completed 24-month follow-up evaluation. Overall, anatomical cure rate was 84.6% and 87.9% in the LSHP group and LSCP/SCH group, respectively, without statistically significant differences. In particular, in the LSHP group the anatomical success rate was 94.9%, 92.3% and 92.3% for the apical, anterior and posterior vaginal compartment whereas in the LSHP group LSCP/SCH was 100%, 91.4% and 94.8%, respectively. Subjective success rate was 89.7% among patients who underwent LSHP and 93.1% among women who underwent LSCP/SCH (p = 0.494). The median operative time (OT) was significantly shorter in LSHP. There were no significant differences between the groups in terms of estimated blood loss, conversion to laparotomy and intra- and postoperative complications. Patients' satisfaction was high in both groups without statistical differences. CONCLUSIONS: Both laparoscopic procedures are safe and effective in the treatment of pelvic organ prolapse. LSHP can be offered as an alternative in women who are strongly motivated to preserve the uterus in the absence of abnormal uterine findings.

Percutaneous-assisted vs mini-laparoscopic hysterectomy: comparison of ultra-minimally invasive approaches.

To assess the feasibility and the safety of the ultra-minimally invasive (U-MIS) approaches in gynecology, we compared our experience in percutaneous assisted hysterectomy (PSS-H) with a series of 3 mm mini-laparoscopy hysterectomy (m-LPS-H). 126 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive hysterectomy: 80 patients received PSS approach and 46 m-LPS approach. For both groups, we evaluated intra and perioperative outcomes, post-operative pain and cosmetic outcomes. The baseline characteristics were comparable between the two study groups. As well, no differences were reported in the clinical indications for hysterectomy, principally fibroids/adenomyosis, endometrial hyperplasia and early stage endometrial cancer. The median operative time was 88.5 (40-190) minutes for PSS-H group and 95.0 (42-231) minutes in m-LPS-H group (p = 0.131). No differences were detected in median estimated blood loss (p = 0.104) as well, in the uterine manipulator usage (p = 0.127) between the two different surgical approaches. Only 1 (2.2%) conversion to standard laparoscopy occurred in m-LPS-H group (p = 0.691). One intra-operative complication was recorded 1 (1.3%) in the PSS-H group (p = 0.367). The post-operative early complication was recorded in five cases of PSS-H group (p = 0.158), none for m-LPS-H procedures. The results in post-operative pain detection was statistically significant after 4 h in favor of m-LPS-H group (p = 0.001). After 30 days no differences in cosmetic satisfaction were detected between the two groups (p = 0.206). PSS-H and m-LPS-H are two valid U-MIS alternatives for benign gynecological conditions and low/intermediate risk endometrial cancer.

Minimally invasive surgery in urogynecology: a comparison of standard laparoscopic, minilaparoscopic, percutaneous surgical system, and robotic sacral colpopexy.

BACKGROUND: We compared surgical outcome of sacral colpopexy (SCP) performed with the most recent minimally invasive surgery such as 3-mm laparoscopy (Mini-LPS), percutaneous system (PSS), standard laparoscopy (LPS), and robotic surgery. METHODS: This is a multicenter retrospective cohort study conducted at Urogynecological Department of the IRCCS A. Gemelli University Polyclinic Foundation in Rome and at the Gynecological Clinic of Maggiore della Carità Hospital in Novara, and of the Polyclinic of Abano. We collected data of 115 patients who underwent laparoscopic SCP for pelvic organ prolapse between June 2017 and June 2018 using PSS, Mini-LPS, standard LPS, and da Vinci Si. RESULTS: Patients of all four groups had similar characteristics. The median operative time (OT) was significantly longer in robotic procedure compared to all other groups There were no significant differences between the four groups in terms of estimated blood loss, conversion to laparotomy, intraoperative complications and median postoperative ileus. Visual Analogue Scale (VAS) at 4 hours was significantly less for Mini-LPS compared to the other techniques. VAS at 24 hours was higher for robotic procedures than other techniques. CONCLUSIONS: Results rule out that minimize surgical invasiveness of laparoscopic techniques could bring improvements in SCP not only from a cosmetic point of view but also from a functional one without requiring longer OT and maintaining the same standard laparoscopic configuration. Even if robotic SCP is useful and safe because of its guarantee of efficiency, it cannot be considered the first choice for many women.

Percutaneous-Assisted versus Laparoscopic Hysterectomy: A Prospective Comparison.

OBJECTIVE: To evaluate the feasibility of percutaneous approach, we prospectively compared our experience in percutaneous-assisted hysterectomy (PSS-H) with that in a series of laparoscopic hysterectomies (LPS-Hs). METHODS: In this multicentric cohort study, from May 2015 to October 2017, 160 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive surgery (MIS): 80 patients received PSS-H and 80 LPS-H. In each group, 30 cases of low-/intermediate-risk endometrial cancer were enrolled. For both groups, we documented preoperative outcomes, postoperative pain, and cosmetic outcomes. RESULTS: No statistically significant differences were noted in baseline characteristics or operative time. We observed significant differences in estimated blood loss: median of 50 cc (PSS-H) and 100 cc (LPS-H) (p = 0.0001). In LPS-H, we reported 4 (5.0%) intraoperative complications and 1 (1.3%) in PSS-H. Thirty-day complications were 4 (5%) in PSS-H and 11 (13.8%) in LPS-H (p = 0.058). No significative differences were found in visual analog scale score, despite a relevant disparity in cosmetic outcome (p = 0.0001). For oncological cases, the 2 techniques had comparable intra- and postoperative outcomes and oncological accuracy. CONCLUSIONS: In this study, we reported that PSS-H is comparable to LPS-H for intra- and perioperative outcomes and postoperative pain, while PSS-H seems to be superior in cosmetic outcomes and patient satisfaction. PSS-H may represent a valid alternative in ultra-MIS for benign gynecological conditions and low-/intermediate-risk endometrial cancer.

Feasibility and perioperative outcomes of percutaneous-assisted laparoscopic hysterectomy: A multicentric Italian experience.

OBJECTIVE: This multicentric prospective phase II study aimed to investigate the feasibility, safety, and efficacy of percutaneous-assisted laparoscopic hysterectomy in terms of perioperative outcomes, feasibility, VAS score, and cosmetic outcomes. STUDY DESIGN: Between May 2015 and October 2017, 382 patients were considered eligible for minimally invasive percutaneous-assisted laparoscopic hysterectomy using Percuvance™, Percutaneous Surgical System - PSS, TELEFLEX ltd. Among them, 80 patients (20.9 %) met the inclusion criteria and were enrolled in the study. The coordinator center was the Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Enrolled patients underwent total percutaneous-assisted laparoscopic hysterectomy ±â€¯bilateral salpingo-oophorectomy ±â€¯nodal assessment. RESULTS: The median age was 52 (range, 32-80) years, and the median body mass index was 25 kg/m2 (range, 16-37). Thirty-five patients (43.8 %) had previous surgery. A median operative time of 82.5 (range, 40-190) minutes and a median estimated blood loss of 50 (50-500) mL were registered. We observed 1 (1.3 %) intraoperative complication. The median time to discharge was 1 (range, 1-5) day. Patients were extremely satisfied with the scar evaluation and postoperative pain control. Five (6.25 %) complications were recorded within 30 days after surgery. CONCLUSION: Percutaneous-assisted technique for extrafascial hysterectomy achieved excellent results in terms of feasibility, safety, and efficacy, even in complex cases and advanced surgical procedures. Therefore, the technique appears to balance the limitations and advantages of minimal surgical invasiveness and standard approach efficacy.

Single-Institution Propensity-Matched Study to Evaluate the Psychological Effect of Minimally Invasive Interval Debulking Surgery Versus Standard Laparotomic Treatment: From Body to Mind and Back.

STUDY OBJECTIVE: To further investigate the psycho-oncologic effect of minimally invasive surgery comparing patients submitted to minimally invasive interval debulking surgery (MI-IDS) with a balanced population treated by standard laparotomy (L-IDS). DESIGN: Single-institution propensity-matched study (Canadian Task Force classification II-2). SETTING: Division of Gynecologic Oncology, "Policlinico A. Gemelli" Foundation, Rome, Italy. PATIENTS: The investigational arm included 30 patients with advanced ovarian cancer treated with MI-IDS, whereas the control arm included a consecutive series of 30 patients with advanced ovarian cancer submitted to L-IDS. For every patient preoperative data were collected to assess the response to neoadjuvant chemotherapy. Perioperative data were also recorded. INTERVENTIONS: A General Well-Being Schedule (GWBS) and a clinical assessment of body uneasiness, the Body Uneasiness Test, were administered by a psycho-oncologist immediately before IDS and within 30 days after surgery to evaluate the psychological burden in both groups. MEASUREMENT AND MAIN RESULTS: Both groups were matched as closely as possible. No statistical differences were registered in terms of surgical procedures and residual tumor. A significantly longer median operative time in patients was counterbalanced by more favorable estimated blood loss and median length of stay and time to chemotherapy. No statistically significant differences were registered in terms of postoperative complications. Starting from a substantially homogenous psychological condition, psychometric evaluation underlined statistically significant differences in favor of MI-IDS. The mean GWBS score was 64.17 ± 11.77 in patients and 54.15 ± 14.76 in control subjects, with a statistically significant difference between the 2 groups (p = .004). CONCLUSION: MI-IDS seems to play an important role in the quality of life and oncologic outcomes. Even if presented data testified a further evolutionary step in oncologic patient care, more experience with larger groups of patients is desirable to deeply investigate and assess our results.

The video endoscopy inguinal lymphadenectomy for vulvar cancer: A pilot study.

OBJECTIVE: This prospective pilot study aims to validate feasibility, efficacy and safeness of the innovative technique of video endoscopy inguinal lymphadenectomy (VEIL) and compare it to open inguinal lymphadenectomy (OIL) in the staging and treatment of vulvar cancer (VC). MATERIAL AND METHODS: All patients affected by VC suitable for bilateral inguinal-femoral lymphadenectomy were prospectively enrolled and submitted to VEIL on one side and OIL contralaterally, sparing the saphenous vein. The surgical and post-surgical data were collected. Univariate analysis included chi square analysis or Fisher's exact test, when appropriate for categorical variables, and the Student t test and Mann-Whitney test when appropriate for continuous variables. RESULTS: Between October 2014 and June 2015 fifteen patients were valuable for the study. Although nodal retrieval was comparable for both procedures, operative time was higher after VEIL. No intraoperative complications were observed in both techniques. Postoperative complications were observed in 3 and 2 cases for OIL and VEIL respectively. One patient needed reoperation after OIL for wound necrosis and infection. According to Campisi's stage, lymphedema resulted significantly to be lower after VEIL (p = 0.024). CONCLUSIONS: Waiting for larger series and longer follow-up data, the VEIL seems to be feasible allowing a radical removal of inguinal lymph nodes as well as OIL with lower morbidity.

Laparoscopic Management of Abdominal Pregnancy.

OBJECTIVE: To illustrate the laparoscopic surgical management of a particular localization of extrauterine pregnancy misdiagnosed until 12 weeks gestational age, complicated by hemoperitoneum and abortion. DESIGN: Canadian Task Force III on the Periodic Health Examination's Levels of Evidence. SETTING: The prevalence of ectopic pregnancy among women presenting to an emergency department with first trimester bleeding, pain, or both ranges from 1% to 16% [1]. The most common localization of ectopic pregnancy is the fallopian tubes, whereas abdominal pregnancy accounts for at least 1% of extrauterine pregnancies. The reported incidence of abdominal pregnancy ranges from 1:10 000 to 1:30 000 pregnancies [2]. Abdominal pregnancy can be localized in the pelvic cul-de-sac, broad ligament, bowel, or pelvic sidewall. This rare type of ectopic pregnancy is often misdiagnosed until later in pregnancy, evolving in hemoperitoneum, abortion, embolism, or rarely, in diagnosed cases, live birth by cesarean section. In the literature, it is recommended that the placenta be left in situ in cases of abdominal pregnancy to avoid hemorrhage and organ injury, even though this approach may be associated with a higher rate of postoperative complications, such as infection, secondary bleeding, and cancer transformation [3]. We present a case of abdominal pregnancy in which the gestational sac was implanted in the broad ligament and resulted in hemoperitoneum at 12 weeks gestational age. INTERVENTION: In August 2010, a 35-year-old woman, gravida 3 para 1, presented at the Di Meglio ultrasound diagnostic center in Naples for a noninvasive prenatal ultrasound (bi-test) to confirm gestational age in what to that point had been considered a normal pregnancy at 12 weeks gestation. Ultrasound revealed an ectopic abdominal pregnancy with a live fetus located in the left parauterine side. A suspicious fluid level in the pouch Douglas was also detected, and so the woman was advised to go to an obstetric hospital for a medical evaluation of the clinical situation (starting hemoperitoneum). Later that same day, the woman presented at the Villa dei Platani Hospital in Avellino, where ultrasound confirmed increased fluid in the pouch of Douglas, along with initial signs of hemoperitoneum and loss of the fetal heartbeat. The woman was immediately transferred to the Malzoni Center for Advanced Endoscopic Gynecological Surgery in Avellino, where she underwent operative laparoscopy for removal of the abdominal pregnancy (surgeon, M.M.). Informed consent for the laparoscopic surgery was provided by the patient in accordance with local regulations. The patient also provided informed consent for the use of images and a video of the procedure. Institutional Review Board approval was not required. The procedure involved laparoscopic hemoperitoneum drainage (at least 500 mL of blood), left adnexectomy after transperitoneal identification of the left uretheral pathway, and complete removal of left broad ligament pregnancy abortion with consensual removal of the ectopic placenta. CONCLUSION: The laparoscopic management of abdominal pregnancy and hemoperitoneum resulting from rupture of the gestational chamber and abortion was optimal. With this minimally invasive technique, it was possible to drain the hemoperitoneum completely and then proceed to total removal of the gestational chamber and the fetus. Thanks to the magnification of the image by laparoscopy, it was also possible to completely remove the placenta and the cotyledons from the peritoneal surface, thereby avoiding possible postoperative bleeding, infection, and sepsis resulting from retention of incomplete removal of the placenta. On the first postoperative day, the patient was in excellent clinical condition, with a marked reduction in circulating ß-human chorionic gonadotropin. She was discharged on the second postoperative day and currently is in good health.

A new approach to supracervical hysterectomy during laparoscopic sacral colpopexy for pelvic organ prolapse: A randomized clinical trial.

AIMS: Laparoscopic sacral colpopexy (LSC) for pelvic prolapse is a complex procedure, characterized by long operative times and, when combined with supracervical hysterectomy, by a high risk of spreading of unsuspected cancerous tissue. The aim of the present study was to compare, in patients who underwent hysterectomy plus LSC for severe POP, different methods for cervical incision and uterine morcellation. METHODS: This is a prospective single Institution randomized double-blinded clinical trial enrolling 124 patients with severe POP from June 2014 to May 2015. Patients underwent laparoscopic supracervical hysterectomy (LSH) plus LSC for pelvic organ prolapse and were randomized in Group 1 (monopolar hook and conventional mechanical morcellator) and Group 2 (bipolar laparoscopic loop and bipolar morcellator), for supracervical incision and uterine morcellation, respectively. Our primary endpoints were the operative times and the secondary endpoints the incidence of intra- or post-operative complications. RESULTS: A total of 50 patients for group completed the study. Baseline characteristics were similar between the groups. Cervical cutting time (32 vs. 3.10 sec; P <0.01), morcellation (4.10 vs. 2.13 min; P <0.01) and operative time (131 vs. 118 min; P <0.05) resulted significantly lower in Group 2. No differences were found in terms of intra- or post-operative complications. CONCLUSIONS: Laparoscopic bipolar loop and morcellator guaranteed a faster and hemostatic tool during supracervical incision and a controlled and rotation-free uterine extraction. The significant surgical time reduction linked to these devices should be considered even more helpful and effective to perform a complex procedure represented by LSH plus LSC. Neurourol. Urodynam. 36:798-802, 2017. © 2016 Wiley Periodicals, Inc.

Needleoscopic Conservative Staging of Borderline Ovarian Tumor.

STUDY OBJECTIVE: To investigate the safety and technical feasibility of needleoscopic fertility-sparing staging of borderline ovarian tumors. DESIGN: Video article and review of the literature (Canadian Task Force classification Level III). SETTING: This 29-year-old woman had a right ovarian cyst suspicious for borderline ovarian tumor on preoperative magnetic resonance imaging and ultrasound showing the presence of a right unilocular ovarian cyst with a papillary projection. Informed consent for abdominal or laparoscopic approach was obtained from the patient in accordance with the local legislation. The patient also provided informed consent to use images and videos of the procedure. Institutional Review Board approval was not required for this kind of procedure. INTERVENTIONS: Treatment involved conservative staging with right ovarian cystectomy, peritoneal biopsies, infracolic omental biopsy, and peritoneal cytology. Instrumentation included two 2.4-mm needleoscopic instruments. The total operative time was 62 minutes, and estimated blood loss was <10 mL. No intraoperative complications were recorded. At the end of the surgical procedure, the outer diameter of the incision was increased by only up to 3 mm. The patient was discharged the day after the procedure. Histopathological analysis confirmed a serous borderline ovarian tumor. A 30 days postoperative follow-up, a satisfactory cosmetic result was reported by both the patient (score of 10 of out of a possible 10) and the surgeon (10 of 10). CONCLUSION: To the best of our knowledge, there are no previously published reports of needleoscopic treatment of borderline ovarian tumor, which represents a great challenge for ultra-minimally invasive approaches [1-3]. Based on our initial experience, the needleoscopic instruments could prove to be a beneficial tool in adnexal benign or borderline disease. At present, only a hybrid operative setting should be considered to overcome the lack of bipolar energy [4-6]. Further studies are needed to define the benefits, advantages, and costs of this novel approach.

Total Laparoscopic (S-LPS) versus TELELAP ALF-X Robotic-Assisted Hysterectomy: A Case-Control Study.

STUDY OBJECTIVE: To compare the feasibility and safety of the TELELAP ALF-X system and standard laparoscopy for total hysterectomy to treat patients with benign and early malignant gynecologic disease. DESIGN: Single-institution retrospective case-control study (Canadian Task Force classification II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: Between October 2013 and May 2015, 203 women underwent TELELAP-ALF X (group 1) or standard laparoscopic (group 2) total hysterectomy and were enrolled. INTERVENTIONS: Total standard laparoscopy vs TELELAP ALF-X robot-assisted hysterectomy for benign and early malignant gynecologic disease. MEASUREMENTS AND MAIN RESULTS: In group 1, the median age was 55 years (range, 40-79 years), median body mass index (BMI) was 25 kg/m(2) (range, 17-38 kg/m(2)), and 51 patients (58%) had undergone previous abdominal surgery. In the control group, the median age was 55 years (range, 34-90 years), median BMI was 25 kg/m(2) (range, 17-41 kg/m(2)), and 31 patients (27%) had previous abdominal surgery. The median operative time was 147 minutes (range, 58-320 minutes) in group 1 and 80 minutes (range, 22-300 minutes) in group 2 (p = .055). The median estimated blood loss was 57 mL (range, 0-600 mL) in group 1 and 99 mL (range, 0-400 mL) in group 2, with no significant differences between the 2 groups (p = .963). Procedures were successfully performed without conversion in 94.3% of cases in the group 1 and in all cases in group 2. Early postoperative pain was significantly lower in group 2. CONCLUSION: TELELAP ALF-X hysterectomy in patients with benign and early malignant gynecologic disease is feasible and safe, and can be considered a valid option for these patients.

Total laparoscopic hysterectomy using a percutaneous surgical system: a pilot study towards scarless surgery.

OBJECTIVE: The evolution of minimally invasive surgery has moved beyond reduction of surgical trauma while maintaining adequate efficacy and safety standards. Percuvance™ Percutaneous Surgical System (PSS) instruments represents the last novelty in this panorama. Consisting of less than 3mm laparoscopic shaft introduced percutaneously with an interchangeable 5mm tool installed in place of the needle tip, they combine micro-invasiveness and operative performance. STUDY DESIGN: We prospectively collected and retrospectively analyzed data of 10 cases of laparoscopic total hysterectomy with Percuvance™ PSS for benign or early malignant gynecological diseases in order to assess the capability and safety of this new device. Data were recorded in a prospectively designed clinical database including patient demographics characteristics, operative data, intra- and postoperative complications, conversion rate, length of hospital stay and cosmetic outcome. RESULTS: The reported series consisted of 10 patients undergoing total laparoscopic hysterectomy with a median age of 51.5 years (range 44-72 years) and a median BMI (body mass index) of 25.3 (range 19.7-30.4). All patients had bilateral salpingo-oophorectomy or bilateral salpingectomy and two of them underwent pelvic lymphadenectomy. A median operative time of 67min (range 45-180min) and a median estimated blood loss (EBL) of 50ml (range 10-100ml) were registered. Median PSS introduction time was 5min (range 3-10min). No conversions to standard laparoscopy or laparotomy were required and no intraoperative complications occurred. Discharge was on day 1 in 4 cases, on day 2 in the other 6 cases. All patients conveyed complete satisfaction with the cosmetic result and postoperative pain control. No complications were registered within 30 days after surgery. CONCLUSIONS: PSS total laparoscopic hysterectomy is safe and feasible with good results in terms of operative time, cosmesis, postoperative pain, recovery and short hospitalization. Further studies are needed to compare PSS total hysterectomy to conventional multi-access laparoscopic and other mini-invasive approaches.

How Technology Can Impact Surgeon Performance: A Randomized Trial Comparing 3-Dimensional versus 2-Dimensional Laparoscopy in Gynecology Oncology.

This randomized clinical trial (Canadian Task Force classification I) aimed to compare 2-dimension (2-D) versus 3-dimensional (3-D) laparoscopic hysterectomy and pelvic lymphadenectomy in endometrial and cervical cancer patients. Between December 2014 and March 2015, 90 patients were enrolled: 29 (32.2%) with early or locally advanced cervical cancer after neoadjuvant treatment and 61 (67.8%) with early-stage endometrial cancer. Patients were randomly assigned to undergo 2-D (Group A, n = 48 [53.3%]) or 3-D (Group B, n = 42 [46.7%)]) laparoscopy. Baseline characteristics were superimposable in the 2 groups. Median operative time was similar in the 2 groups. Median estimated blood loss during lymphadenectomy was significantly lower in Group B than in Group A (38 mL [range, 0-450] vs 65 mL [range, 0-200]; p = .033). In cervical cancer patients operative time of pelvic lymphadenectomy performed by "novice" surgeons (those with <10 procedures performed) was statistically significantly lower in Group B (p = .047). No differences in perioperative outcomes and postoperative complications were observed between the 2 groups. The 2-D and 3-D systems can be used safely in laparoscopic hysterectomy. However, the 3-D system could provide key benefits to intraoperative techniques and postoperative outcomes in reducing operative time for "expert" surgeons and in enhancing surgical precision for "novice" surgeons.

Laparoscopic Management of Ovarian Cancer Patients With Localized Carcinomatosis and Lymph Node Metastases: Results of a Retrospective Multi-institutional Series.

STUDY OBJECTIVE: To investigate the feasibility and safety of laparoscopic cytoreduction in ovarian cancer patients with localized carcinomatosis or lymph node involvement. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Multi-institutional study performed in 6 referral gynecologic oncology units. PATIENTS: Between June 2005 and December 2014, preoperatively presumed early-stage ovarian cancer patients, who accidentally revealed localized carcinomatosis or lymph node involvement at laparoscopic evaluation or at postoperative pathological examination managed by the laparoscopic approach. INTERVENTIONS: All patients with limited carcinomatosis and/or lymph node metastases underwent complete laparoscopic cytoreduction. MEASUREMENTS AND RESULTS: Sixty-nine patients were included in the analysis. Twenty-eight (40.6%) patients were staged III C because they had lymph node metastases. Pelvic lymphadenectomy was performed in 75.4% of cases, whereas aortic lymphadenectomy was performed in 79.7% of cases. Lymph node metastases were found in pelvic and aortic regions in 11 and 13 patients, respectively, whereas 4 patients had lymph node metastases in both regions. Twelve (17.4%) patients underwent complete pelvic peritonectomy because of the presence of nodules localized in several pelvic region sites. As of May 2015, the median follow-up was 35 months, and the median disease-free survival was 29 months. The 2-year disease-free survival rate was 77.1%, whereas the 2-year overall survival rate was 90.6%. The median time to recurrence was 26 months (range, 6 -55 months); 15 (21.7%) patients developed recurrence. CONCLUSION: The present study shows the technical and clinical feasibility of laparoscopic cytoreduction in ovarian cancer patients with limited carcinomatosis or lymph node involvement.

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

INTRODUCTION: 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. MATERIALS AND METHODS: Cost analysis was performed on 81 patients who underwent a Telelap ALF-X robotic hysterectomy. Data were collected during a phase II study trial conducted at the University Hospital A. Gemelli, Catholic University, Rome. According to micro-costing technique, surgical team costs, materials and operating theatre usage were recorded during each surgical intervention. Cost data were provided by the hospital's accounting office. Probabilistic sensitivity analysis was carried out in order to test the robustness of the results by assuming an Inv-norm random variable. RESULTS: The base case analysis showed a cost/patient of €3391.82. The new robotic device requires a low consumption of robotic materials. Sensitivity analysis showed that the most sensitive cost driver was use of the operating theatre. CONCLUSION: This study shows that Telelap ALF-X robotic hysterectomy is feasible and safe and could offer specific advantages in terms of cost. Copyright © 2016 John Wiley & Sons, Ltd.

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.

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

BACKGROUND: To assess the learning curve associated with tele-assisted surgery. METHODS: We performed a training box-based study, describing speed and accuracy in volunteers performing basic and complex laparoscopic tasks, to assess performance and in the skill acquisition of inexperienced users, using the Telelap Alf X system. Ten surgeons in gynaecology who had never received formal instruction on this new surgical device, completed four modules during a consecutive 3 day training programme. RESULTS: All the participants completed the training programme with a good learning curve. CONCLUSIONS: Use of the TELELAP Alf X advanced surgical robotic system is associated with a rapid learning curve among experienced surgeons. Copyright © 2015 John Wiley & Sons, Ltd.

The new robotic TELELAP ALF-X in gynecological surgery: single-center experience.

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/m(2)). 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.