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 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.

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.

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.

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.

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.

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.

Total Laparoscopic Hysterectomy With Percutaneous (Percuvance) Instruments: New Frontier of Minimally Invasive Gynecological Surgery.

STUDY OBJECTIVE: To highlight the first case of laparoscopic hysterectomy performed with percutaneous instruments (The Percuvance System, Teleflex Incorporated, Wayne, PA). DESIGN: The basis of the system is a <3-mm diameter shaft that, when connected to an introducer tool tip, can be inserted percutaneously through the skin. The introducer tool tip can then be exchanged outside the body for a wide variety of 5-mm interchangeable surgical tool tips. The shaft is sufficiently strong to hold structures, and surgeons can use its interchangeable tool tips to grasp, cut, and manipulate tissue. We used a 3-dimensional high-definition 10-mm flexible tip endoscope (ENDOEYE FLEX 3D, Olympus Winter & IBE GMBH, Hamburg, Germany). BACKGROUND: Minilaparoscopy is an attractive approach for hysterectomy due to advantages such as reduced morbidities and enhanced cosmesis. However, it has not been popularized because of the lack of suitable instruments and high technical demand. The Percuvance system represents a significant advance in minimally invasive surgery. SETTING: Catholic University of the Sacred Hearth, Rome, Italy. PATIENT: A 53-year-old, multiparous patient with endometrial endometroid cancer grade 1, Fédération Internationale de Gynécologie et d'Obstétrique stage IA. The patient provided informed consent to use the images and video of the procedure. Institutional review board approval was not required. INTERVENTION: The patient was hysteroscopically diagnosed with endometrial cancer after removal of an endometrial polyp adnexectomy. Once referred to our center, surgical staging was planned, including total hysterectomy and bilateral adnexectomy. Laparoscopy with 2 lateral percutaneous and 1 soprapubic 3-mm instruments was believed to be feasible to achieve these procedures. MAIN RESULTS: The operation was performed successfully with no intraoperative or postoperative complications. Operative time was 80 minutes overall, and blood loss was 50 mL. The pathology report confirmed endometrial endometroid cancer grading 1, Fédération Internationale de Gynécologie et d'Obstétrique stage IA. The patient was discharged on day 1. After 2 months, no late complications or recurrence was detected. CONCLUSION: Percutaneous total hysterectomy is technically feasible, and the use of this novel device permits surgeons to maintain a standard setting. Further studies are mandatory to define the benefits, advantages, and costs of this novel approach with respect to other minimally 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.

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.

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.

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.

TELELAP ALF-X Robotic-assisted Laparoscopic Hysterectomy: Feasibility and Perioperative Outcomes.

STUDY OBJECTIVE: 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). DESIGN: Phase II study (Canadian Task Force II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: 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). INTERVENTIONS: Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSION: 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.

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.

Randomized study comparing use of THUNDERBEAT technology vs standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer.

STUDY OBJECTIVE: To compare operative time with use of THUNDERBEAT (TB) vs standard electrosurgery (SES) during laparoscopic radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors. DESIGN: Evidence obtained from a properly designed, randomized, controlled trial (Canadian Task Force classification I). SETTING: Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome, Italy. PATIENTS: Fifty patients with early cervical cancer (FIGO stages IA2, IB1, IIA <2 cm) or locally advanced cervical cancer (FIGO stages IB2, IIA >2cm, IIB) who received neoadjuvant treatment (chemotherapy or radiochemotherapy) and demonstrated a complete or partial clinical response and early stage endometrioid endometrial cancer (FIGO stages IB, II) were randomly assigned to undergo TB (arm A) or SES (arm B). INTERVENTION: Laparoscopic radical hysterectomy with bilateral pelvic lymphadenectomy, using an easily reproducible technique was performed. MEASUREMENTS AND MAIN RESULTS: Fifty patients were available for analysis, with 25 women randomly assigned to TB (arm A) and 25 to SES (arm B). The median operative time was 85 minutes for TB vs 115 minutes for SES (p = .001). At multivariate analysis, endometrial cancer (p = .001) and TB (p = .001) were independently associated with shorter operating time. No differences in perioperative outcomes and postoperative complications were observed between the 2 arms. Patients who underwent TB reported less postoperative pain, both at rest (p = .005) and after the Valsalva maneuver (p = .008), with less additional analgesic therapy other than standard therapy required in patients who underwent SES (p = .02). CONCLUSION: TB is associated with shorter operative time and less postoperative pain than is the standard technique (SES) in patients with uterine cancer.

Standardized training programmes for advanced laparoscopic gynaecological surgery.

PURPOSE OF REVIEW: To provide an overview of the available evidence on the role of the different methods in laparoscopic training, and to summarize the results obtained with standardized training programmes in advanced laparoscopic gynaecological surgery. RECENT FINDINGS: Box trainers as well as virtual reality simulators ensure a benefit in terms of surgical skills development. No data are available showing superiority of one method compared to another. Global Operative Assessment of Laparoscopic Skills (GOALS) remains the most widely used and established scoring system to assess the acquired laparoscopic abilities, also in the field of advanced gynaecological surgery. Standardized training programmes have been recognized as reliable tools able to improve the development of surgical skills, particularly for innovative surgical techniques, such as laparoscopic endoscopic single-site surgery. SUMMARY: The traditional approach based on observing and assisting needs to be updated incorporating box trainers and virtual reality simulators. The development of innovative training methods, integrating box trainers and virtual reality simulators, represents the future horizon. All tertiary centres involved in advanced laparoscopic gynaecological surgery should contribute to the development of an integrated network of standardized training programmes, in order to ensure a high-quality laparoscopic training to gynaecologists.

Minilaparoscopic versus single-port total hysterectomy: a randomized trial.

STUDY OBJECTIVE: To compare perioperative outcomes and postoperative pain of minilaparoscopic (M-LPS) and laparoendoscopic single-site total hysterectomy (LESS). DESIGN: Prospectively randomized study (Canadian Task Force classification II-2). SETTING: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome. PATIENTS: A total of 86 patients underwent total hysterectomy. Seventy-one met the inclusion criteria and were included in this study. Three of them refused randomization, 34 were randomly assigned to undergo to single-port hysterectomy and 34 to undergo to minilaparoscopy. INTERVENTIONS: The operative technique is the same in the 2 groups with the exception of videolaparoscopy, port type, and some specific instruments. All surgical procedures were performed with an intrauterine manipulator. Single-port hysterectomy was performed through a multichannel single trocar inserted in the umbilicus. Minilaparoscopic hysterectomy was performed through one optical transumbilical 5-mm trocar and three 3-mm suprapubic ancillary ports. MEASUREMENTS AND MAIN RESULTS: Sixty-eight patients met the inclusion criteria and were enrolled in the study. The baseline characteristics of the 2 groups were comparable. Median operative time was longer in LESS with respect to M-LPS (120 minutes vs 90 minutes; p = .038). There were no differences between the 2 groups for median estimated blood loss, ileus, and postoperative stay. Additional 5-mm port insertion was needed in 1 case (2.9%) in the M-LPS group and in 2 cases (5.9%) in the LESS group, respectively (p = .311). No patient had development of intraoperative or early postoperative complications. Patients in the M-LPS group experienced a minor pain at each evaluation, compared with patients who underwent LESS. The rescue analgesic requirement was similar in the 2 groups. CONCLUSIONS: Laparoscopic hysterectomy can be safely performed by M-LPS and LESS. M-LPS is associated with significantly lower operative time and less postoperative pain than LESS. Advantages of M-LPS hysterectomy than LESS have no noteworthy impact on the patients' early postoperative management. The decision on the best access to the hysterectomy might take into account the surgeon's skill and feeling with the different possible approaches.

Total microlaparoscopic radical hysterectomy in early cervical cancer.

BACKGROUND AND OBJECTIVE: In less than 2 decades, laparoscopy has contributed to modification in the management of early cervical cancer patients, and all comparisons between open and laparoscopic-based radical operations showed an identical oncological outcome. The aim of this study is to describe surgical instrumentations and technique to perform total microlaparoscopy radical hysterectomy in early cervical cancer patients and report our preliminary results in terms of operative time and perioperative outcomes. METHODS: Between January 1, 2012, and March 25, 2012, 4 consecutive early cervical cancer patients were enrolled in this study. RESULTS: We performed 3 type B2 and 1 type C1-B2 total microlaparoscopy radical hysterectomy, and in all cases concomitant bilateral salpingo-oophorectomy and pelvic lymphadenectomy were carried out. Median operative time was 165 minutes (range: 155 to 215) (mean: 186), and median estimated blood loss was 30 mL (range: 20 to 50). Median number of pelvic lymph nodes removed was 12 (range: 11 to 15). All procedures were completed without 5-mm port insertion and without conversion. No intraoperative or early postoperative complications were reported. CONCLUSIONS: This report suggests a role of microlaparoscopy in the surgical management of early cervical cancer with adequate oncological results, superimposable operative time, and perioperative outcomes with respect to standard laparoscopy.

Total laparoendoscopic single-site surgery (LESS) hysterectomy in low-risk early endometrial cancer: a pilot study.

BACKGROUND: In the last few years, technical advances have produced a dramatic shift from traditional open surgery toward a minimally invasive approach, even in oncological procedures. We present our initial experience with laparoendoscopic single-site surgery (LESS) in the surgical treatment of early-stage endometrial cancer patients. METHODS: Between July 2009 and May 2010, 20 consecutive low-risk early endometrial cancer patients were enrolled in this single institution prospective cohort trial. RESULTS: The median age of the patients was 57 years (range = 42-68) and median body mass index was 24 kg/m(2) (range = 21-30). Median operative time was 105 min (range = 85-155) and median estimated blood loss was 20 ml (range = 10-180). The larger skin and fascial incision required for the single-port approach was 2.5 cm (median = 2.2 cm; range = 2.0-2.5). No laparoscopic/laparotomic conversion was registered, and no insertion of additional ports was necessary. Median ileus was 16 h (range = 12-20) and median time to discharge was 1 day (range = 1-2). All patients were completely satisfied with the cosmetic results and postoperative pain control. CONCLUSIONS: Laparoendoscopic single-site surgery could represent a surgical option for extra-fascial hysterectomy in early-stage endometrial cancer patients, with the potential to further decrease invasiveness of the conventional laparoscopic approach.

Laparoscopic, minilaparoscopic and single-port hysterectomy: perioperative outcomes.

OBJECTIVE: This study was designed to compare perioperative outcomes and postoperative pain of standard laparoscopic (S-LPS), minilaparoscopic (M-LPS), and laparoendoscopic single-site (LESS) hysterectomy. METHODS: A single-institutional, matched, retrospective, cohort study was performed. Between May 2010 and March 2011, 85 consecutive women were submitted to a total laparoscopic hysterectomy by S-LPS, M-LPS, and single-port LESS. Perioperative outcomes of these three techniques were analyzed and compared. RESULTS: Demographics and baseline characteristics of each group were absolutely comparable. The median operative time was longer [105 (range, 75-125) min] in the LESS group compared with the M-LPS group [90 (range, 60-120) min; p < 0.011] and S-LPS [80 (range, 50-110) min; p < 0.001]. No statistically significant differences have been reported for estimated blood loss or intra- and early postoperative complications. Postoperative pain control was better for LESS and M-LPS than S-LPS. CONCLUSIONS: M-LPS and LESS hysterectomy can be performed safely, and both seem to be associated with a halving of early postoperative pain with a lower request of analgesics.