Minimally invasive versus open pelvic exenteration in gynecological malignancies: a propensity-matched survival analysis.

OBJECTIVE: The primary endpoint of this study was to compare the disease-free survival of patients undergoing open versus minimally invasive pelvic exenteration. The secondary endpoints were cancer-specific survival and peri-operative morbidity. METHODS: A multi-center, retrospective, observational cohort study was undertaken. Patients undergoing curative and palliative anterior or total pelvic exenteration for gynecological cancer by a minimally invasive approach and an open approach between June 2010 and May 2021 were included. Patients with distant metastases were excluded. A 1:2 propensity match analysis between patients undergoing minimally invasive and open pelvic exenteration was performed to equalized baseline characteristics. RESULTS: After propensity match analysis a total of 117 patients were included, 78 (66.7%) and 39 (33.3%) in the open and minimally invasive group, respectively. No significant difference in intra-operative (23.4% vs 10.3%, p=0.13) and major post-operative complications (24.4% vs 17.9%, p=0.49) was evident between the open and minimally invasive approach. Patients undergoing open pelvic exenteration received higher rates of intra-operative transfusions (41.0% vs 17.9%, p=0.013). Median disease-free survival was 17.0 months for both the open and minimally invasive groups (p=0.63). Median cancer-specific survival was 30.0 months and 26.0 months in the open and minimally invasive groups, respectively (p=0.80). Positivity of surgical margins at final histology was the only significant factor influencing the risk of recurrence (hazard ratio (HR) 2.38, 95% CI 1.31 to 4.31) (p=0.004), while tumor diameter ≥50 mm at the time of pelvic exenteration was the only significant factor influencing the risk of death (HR 1.83, 95% CI 1.08 to 3.11) (p=0.025). CONCLUSION: In this retrospective study no survival difference was evident when minimally invasive pelvic exenteration was compared with open pelvic exenteration in patients with gynecological cancer. There was no difference in peri-operative complications, but a higher intra-operative transfusion rate was seen in the open group.

Post Treatment Sexual Function and Quality of Life of Patients Affected by Cervical Cancer: A Systematic Review.

Introduction: The aim of this study is to analyze the available scientific evidence regarding the quality of life (QoL) and sexual function (SF) in patients affected by cervical cancer (CC) after surgical and adjuvant treatments. Materials and Methods: Preliminary research was conducted via electronic database (MEDLINE, PubMed and Cochrane Library) with the use of a combination of the following keywords: SF, QoL, and CC. The principal findings considered in the present review were the study design, the number of patients included in each study, the information about the malignancy (histology and stage of disease), the questionnaires administered, and the principal findings concerning SF and QoL. Results: All studies were published between 2003-2022. The studies selected consisted of one randomized control study, seven observational studies (three prospective series), and nine case control studies. The scores used were focused on SF, QOL, fatigue, and psychological aspects. All studies reported a decreased SF and QOL. The most developed questionnaires were the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression scale (HADS), and the Female Sexual Distress Scale (FSDS). Discussion: All studies reported a decreased SF and QOL. In addition to the perception of body image, several factors coexist in influencing the outcomes such as the physical, hormonal, psychological. Conclusions: Sexual dysfunction after CC treatment has a multifactorial aetiology which negatively affects the quality of life. For these reasons, it is important to follow and support patients with a multidisciplinary team (doctors, nurses, psychologists, dieticians) before and after therapy. This type of tailored therapeutic approach should become a standard. Women should be informed about possible vaginal changes and menopausal symptoms after surgery and on the positive effects of psychological therapy.

Nomogram to predict feasibility of minimally invasive interval debulking surgery in advanced ovarian cancer.

OBJECTIVE: Currently, there is no clear guidance defining the ideal candidate for minimally invasive interval debulking surgery. This study aimed to identify predictive factors for a minimally invasive approach in patients with advanced ovarian cancer who are candidates for interval debulking surgery after neoadjuvant chemotherapy. METHODS: This was a single institution retrospective study conducted between January 2014 and June 2020 Perioperative variables were used to predict the likelihood of minimally invasive interval debulking surgery using multivariable models. A nomogram was developed, and internal validation was performed using the bootstrapping correction technique. This nomogram was built to visualize the effect of perioperative variables on the estimated probability of minimally invasive interval debulking surgery in patients with a clinical response after neoadjuvant chemotherapy. We used the four significant perioperative variables according to logistic regression. RESULTS: A total of 108 (28.4%) and 272 (71.6%) patients underwent interval debulking surgery by a minimally invasive or open approach, respectively. Absence of omental cake (odds ratio (OR) 9.15, 95% confidence interval (CI) 4.26 to 19.64, p<0.001), high volume surgeon (OR 5.43, 95% CI 2.75 to 10.71, p<0.001), less than two peritoneal sites involved (OR 2.94, 95% CI 1.34 to 6.43, p=0.007), and CA125 normalization (OR 1.79, 95% CI 1.05 to 3.36, p=0.049) correlated with the feasibility of minimally invasive interval debulking surgery at multivariate analysis. The calibration plot demonstrated good agreement between the predicted and actual probability of minimally invasive interval debulking surgery (p=0.93, Hosmer-Lemeshow test). CONCLUSIONS: Our nomogram may serve as a useful tool to choose the surgical approach in patients with advanced ovarian cancer undergoing interval debulking surgery.

A Laparoscopic Adjusted Model Able to Predict the Risk of Intraoperative Capsule Rupture in Early-stage Ovarian Cancer: Laparoscopic Ovarian Cancer Spillage Score (LOChneSS Study).

STUDY OBJECTIVE: To identify preoperative/intraoperative patient and tumor characteristics associated with an increased risk of tumor spillage during minimally invasive surgery (MIS) for early-stage ovarian cancer (OC). The secondary end point was to develop a score system able to estimate the risk of tumor rupture during MIS. DESIGN: Retrospective observational study. SETTING: Patients with International Federation of Gynecology and Obstetrics stage I OC. PATIENTS: Patients aged ≥18 years old, with International Federation of Gynecology and Obstetrics stage IA to IC1 OC of any histology. INTERVENTIONS: Preoperative and intraoperative characteristics of patients treated with MIS for early-stage OC at Policlinico Universitario Agostino Gemelli, IRCCS in Rome, Italy, from January 1, 2001, to December 31, 2017, were collected. MEASUREMENTS AND MAIN RESULTS: A total of 151 patients were included. Previous pelvic surgery was more represented in patients with nonruptured tumors (46.0% vs 63.4%; p = .042). In addition, a larger tumor diameter (p <.001), a higher body mass index (p = .032), ultrasound characteristics (p = .029), and adhesions to large bowel (14% vs 2.0%; p = .003), uterus (44% vs 6.9%; p <.001), contralateral ovary (8.0% vs 0%; p = .004), ovarian fossa (64% vs 14.9%; p <.001), and pouch of Douglas peritoneum (32% vs 4.0%; p <.001) increased rupture rate. At multivariate analysis, a larger tumor diameter (p <.001) and adhesions to ovarian fossa peritoneum (p = .007) were independently associated with intraoperative cancer spillage and included in the score calculation. A disease-free survival (DFS) difference between the rupture group and the no-rupture group was detected (5-year DFS, 74.9% vs 94.4%; p = .011), with superimposable overall survival (5-year overall survival, 91.2% vs 97.9%; p = .089). CONCLUSION: Some preoperative/intraoperative characteristics increase the risk of tumor rupture during MIS for early-stage OC. A laparoscopic predictive model of capsule disruption could be considered to intraoperatively tailor surgical approach to prevent tumor spillage and avoid affecting patient's DFS.

Peritoneal HPV-DNA test in cervical cancer (PIONEER study): A proof of concept.

The aim of this study was to investigate the prevalence of peritoneal human papillomavirus (HPV) infection in different clinical cervical cancer (CC) settings, and its association with potential clinical and/or histological factors. This is a single-center, prospective, observational study. Consecutive patients with newly diagnosed or recurrent/persistent CC, between March 2019 and April 2020, were included. A group of patients undergoing surgery for benign gynecological conditions was included as control group. All patients underwent HPV-DNA test in the cervix and in the peritoneal cavity simultaneously at time of surgery. Two-hundred seventy-two patients had cervical and peritoneal HPV test analyzed. Cervical and peritoneal HPV positivity (PHP) was found in 235 (88.0%) and 78 (28.7%) patients, respectively; the prevalence of PHP was 17.7% in early stage, 28.8% in locally advanced cervical cancer (LACC) and 46.6% in the metastatic/persistent/recurrent setting (P = .001). No control patient was found to have peritoneal HPV infection. Higher frequency of PHP was documented in patients with larger tumor size (P = .003), presence of cervical HPV 16/18 genotypes (P < .001), higher number of cervical high-risk (HR)-HPV per patient (P = .018) and peritoneal carcinomatosis (P < .001). Multivariate analysis demonstrated that lack of preoperative cervical conization in early stages (P = .030), while higher International Federation of Gynecology and Obstetrics (FIGO) stage (P = .021) and presence of cervical HPV 16/18 (P = .001) in LACC, was associated with PHP. This is a proof-of-concept study. A number of potential clinical implications, including prognosis, could be obtained by further studies.

Uterine artery closure at the origin vs at the uterus level in total laparoscopic hysterectomy: A randomized controlled trial.

INTRODUCTION: The transfusion rate in hysterectomies for benign pathology is almost 3%. However, despite the strong interest in reducing intraoperative bleeding, limited evidence is available regarding the technical aspects concerning uterine vessel management during a total laparoscopic hysterectomy (TLH). Uterine artery (UA) closure in TLH can be performed at the origin from the internal iliac artery or at the uterus level (UL). However, low-quality evidence is available regarding the superiority of one method over the other. MATERIAL AND METHODS: We performed a single-blind randomized (1:1) controlled trial (NCT04156932) between December 2019 and August 2020. One hundred and eighty women undergoing TLH for benign gynecological diseases were randomized to TLH with UA closure at the origin from the internal iliac artery (n = 90), performed at the beginning of the procedure by putting two clips per side at the origin, vs closure at the UL (n = 90). Intraoperative blood loss estimated from suction devices was the primary outcome. Secondary end points were perioperative outcomes, the conversion rate from one technique to the other, and complication rates with 4 months of follow up. RESULTS: Uterine artery closure at the origin was completed in all 90 patients (0%), whereas closure at the UL was converted to closure at the origin in 11 cases (12.2%; p < 0.001); failures were mainly associated with the presence of endometriosis (81.8% [9/11] vs 10.1% [8/79]; p < 0.001). In the intention-to-treat analysis, the intraoperative blood loss was higher in the group assigned to the closure at the UL (108.5 mL) than in the group with closure at the origin (69.3 mL); the mean difference was 39.2 mL (95% CI 13.47-64.93 mL; p = 0.003). Other perioperative outcomes and complications rates did not differ. CONCLUSIONS: Uterine artery closure at the origin reduces intraoperative blood loss during a TLH and appears to be more reproducible than closure at the UL without higher complication rates. However, the absent translation in clinical benefits impedes the support of a clinical superiority in all women. Closure at the origin may provide clinical advantages in the presence of severe preoperative anemia or pelvic anatomic distortion.

Surgical Neuropelveology: Lateral Femoral Cutaneous Nerve Endometriosis. Laparoscopic Resection and Nerve Transplantation.

STUDY OBJECTIVE: To demonstrate the application of surgical neuroanatomic principles for the diagnosis and treatment of deep infiltrating endometriosis involving the lateral femoral cutaneous nerve. DESIGN: Video demonstration of laparoscopic lateral femoral cutaneous endometriosis resection with nerve transplant. SETTING: Endometriosis infiltrating somatic nerves is a poorly known condition, which can cause severe neuropathic symptoms [1] and is often unrecognized with a subsequent treatment delay [1]. Intimate knowledge of pelvic neuroanatomy and expertise in minimally invasive surgery are essential to manage this challenging surgical scenario [2-4]. INTERVENTIONS: Thirty-six years old patient with primary infertility and chronic pelvic pain associated with dysmenorrhea, dyspareunia, dysuria, and dyschezia. Preoperative magnetic resonance imaging detected a 3-cm parauterine and a 2-cm retrocervical endometriosis nodule. Magnetic resonance imaging did not demonstrate pelvic nerve involvement. Preoperative neuropelveologic assessment demonstrated a significant hypoesthesia of the corresponding lateral femoral cutaneous nerve dermatome, representing the primary complaint. A swab test showed spotting areas of allodynia. These findings prompted us to investigate for a right lateral femoral cutaneous entrapment. Laparoscopy showed an endometriosis nodule infiltrating the right lateral femoral cutaneous nerve. A resection of the nerve was necessary, and a subsequent reconstruction with a collagen bovine neuro-guide was carried out. The operative time was 300 minutes, and the estimated blood loss was 150 mL. Hospital stay was 3 days. After 3 months, the patient showed a clinical improvement in the pain and hypoesthesia on the reconstructed nerve dermatome. CONCLUSION: Neuropelvic anatomic assessment should be considered during the preoperative evaluation for patients with endometriosis who have pelvic pain and neuropathy as part of the diagnostic process [5]. This unique case demonstrates that nerve resection and transplantation can be used in specific situations for neuropathy related to deep infiltrative endometriosis of pelvic nerves.

Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).

OBJECTIVE: To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load. METHODS: Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population. RESULTS: 171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56). CONCLUSIONS: Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.

Step by Step Total Laparoscopic Hysterectomy with Uterine Arteries Ligation at the Origin.

STUDY OBJECTIVE: To reveal principles and the feasibility of a total laparoscopic hysterectomy (TLH) with uterine artery ligation at the origin. DESIGN: Step-by-step demonstration and explanation of technique using videos from patients. SETTING: Gynecologic oncology unit at a university hospital. PATIENT: A 54-year-old woman with uterine fibromatosis and metrorrhagia. INTERVENTION: TLH has 7 common components. First, round ligaments are coagulated and cut to enter the retroperitoneum. The ureter is identified. Second, pararectal spaces are entered between the ureter and the internal iliac artery. This maneuver allows the identification of the uterine artery as it leaves its origin from the internal iliac artery. The uterine vessels are stapled with a vascular endoscopic stapler at their origin from the hypogastric vessels or sealed with a bipolar device. Third, adnexal structures are separated from the uterine corpus for subsequent preservation or removal. Fourth, the blood supply is dissected, occluded, and divided before extirpation of the uterine corpus. Fifth, the cardinal ligament complex is transected with colpotomy, and the cervix is amputated from the vaginal apex. Sixth, the specimen is removed. Finally, the vaginal cuff is closed [1]. MEASUREMENTS AND MAIN RESULTS: Laparoscopic hysterectomy was first described by Reich et al. [2] in 1989 and has slowly gained popularity. Today, hysterectomy is the most common gynecologic procedure performed. TLH is where the entire operation (including suturing of the vaginal vault) is performed laparoscopically and there is no vaginal component except for the removal of the uterus. Currently, hysterectomies are performed by different approaches, and individual surgeons have different indications for the approach to hysterectomy based largely on their own array and patient characteristics. TLH requires the highest degree of laparoscopic surgical skills [3], and knowledge of pelvic anatomy defines a safe space for sharp entry into the retroperitoneum and safe identification of pelvic vasculature. CONCLUSION: We present an educational video with step-by-step explanation of the technique to highlight the anatomic landmarks that guides the procedure.

Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire.

STUDY OBJECTIVE: The effect of the different types of vaginal cuff closures on posthysterectomy sexual function has not been investigated in depth. We evaluated if there is a difference between transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH) on female sexual function, using a validated questionnaire. DESIGN: Secondary analysis of a prospective randomized controlled trial. SETTING: Three academic research centers. PATIENTS: Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included. INTERVENTIONS: Patients were randomly assigned to a laparoscopic or transvaginal approach for vaginal cuff closure at the end of TLH for benign indications. MEASUREMENTS AND MAIN RESULTS: A validated questionnaire (the Female Sexual Function Index [FSFI]) was used to explore sexuality before and after the operation. Of the 1408 patients enrolled in the primary study, 400 patients were asked to complete the questionnaire. Of them, 182 (41.4%) were eligible and accepted enrollment in the present analysis. No difference was found in terms of pre- and postoperative FSFI scores between groups. Patients with a low preoperative FSFI score (<26.55) had a significantly higher likelihood of having a postoperative sexual disorder (p <.001). Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively). After multivariable analysis, both variables maintained at least a tendency toward an association with a lower postoperative FSFI score (odds ratio, 2.696; 95% confidence interval, 1.010-7.194; p = 0.048 and p = 0.053; odds ratio, 13.2; 95% confidence interval, .966-180.5, respectively). CONCLUSION: Transvaginal and laparoscopic cuff closures after TLH have similar sexual postoperative outcomes. A patient with sexual problems before TLH is more likely to have a low FSFI score postoperatively. Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma have a worse postoperative sexual life. (Clinicaltrials.gov, protocol number NCT02453165, registration date May 25, 2015.).

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.

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.

Upfront HIPEC and bevacizumab-containing adjuvant chemotherapy in advanced epithelial ovarian cancer.

INTRODUCTION: In advanced epithelial ovarian cancer patients, the standard of care is primary debulking surgery, followed by first-line chemotherapy often with bevacizumab addiction. In this context, some experiences have shown that a comprehensive treatment approach to surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) could improve the prognosis. OBJECTIVE: This is a study aimed to explore the feasibility of primary debulking surgery and HIPEC upfront followed by first-line therapy with bevacizumab. STUDY DESIGN: Phase II monocentric, open label, non-randomised and single-arm study. Forty patients affected by advanced ovarian cancer submitted to primary debulking surgery with HIPEC were enrolled in the study. After surgery, all patients underwent systemic chemotherapy with bevacizumab addiction. RESULTS: Complete cytoreduction (RT = 0) was achieved in all cases. Treatment-related early complications were observed in 23 patients and in 15 cases were G1-G2. Major complications were reported in 8 patients. No postoperative death was recorded. Subsequent chemotherapy was administered in all cases. Median time between surgery and first cycle of chemotherapy was 42 days (range 30-76). Concomitant bevacizumab was administered in 34 patients (85%). Maintenance with bevacizumab was feasible in 33 patients (82.5%) and its withdrawal was necessary for 1 patient (2.5%) due to G3 hypertension. CONCLUSION: Our data suggest that HIPEC can be safely introduced in the upfront therapy of advanced ovarian 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.

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.

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.

Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study.

BACKGROUND: Laparoscopy has acquired an increasing role in the management of ovarian cancer. Laparoscopic cytoreduction could represent a new frontier for selected patients after neoadjuvant chemotherapy (NACT). OBJECTIVE: We sought to assess feasibility and early complication rate of minimally invasive (MI) interval debulking surgery (IDS) in stage III-IV epithelial ovarian cancer (EOC) patients after NACT. STUDY DESIGN: This is a phase II multicentric study in advanced EOC cases with clinical complete response after NACT, according to Gynecologic Cancer Intergroup and Response Evaluation Criteria In Solid Tumors criteria. Institutional review board approval was obtained and all patients signed written informed consent to be included in the protocol. The study was registered in clinicaltrials.gov (NCT02324595) and was named "MISSION" trial. For patients meeting inclusion criteria, surgical procedures started with diagnostic laparoscopy to confirm preoperative findings and assess surgical complexity. MI-IDS included hysterectomy, bilateral salpingo-oophorectomy, appendectomy, omentectomy, peritonectomy, and bowel resection. Pelvic and/or aortic lymphadenectomy was not considered as standard procedure in these cases. Intraoperative and postoperative outcomes, time to restart chemotherapy, survival rate, and quality of life data were registered. RESULTS: From December 2013 through February 2015, of 184 advanced EOC patients considered eligible for IDS, 52 (28.2%) met inclusion criteria and were enrolled in the study. For 22 (12%) of them, standard laparotomic approach was preferred because of intraoperative surgeon evaluation. Thirty (16.3%) patients received the planned treatment of MI-IDS. Median age was 61 (range 39-81) years and median body mass index was 24 (range 20-31) kg/m(2). Median numbers of NACT cycles was 4 (range 3-7). Median operative time was 285 (range 124-418) minutes and median estimated blood loss was 100 (range 50-200) mL. Surgical procedures included 28 (93.3%) hysterectomy and bilateral salpingo-oophorectomy, 29 (96.6%) omentectomy, 2 (6.6%) appendectomy, 11 (36.6%) regional peritonectomy, and 1 (3.4%) bowel resection. A residual tumor of 0 cm was reached in 29 (96.6%) patients and 0.5 cm in only 1 (3.4%) case. The vast majority of patients were discharged on postoperative day 2 (range 2-3). No early postoperative complications were registered. Median time to restart chemotherapy was 20 (10-30) days and all patients successfully completed the cycles. Histological findings showed 3 (10%) complete response, 9 (30%) microscopic residual disease, and 18 (60%) evidence of macroscopic residual disease. With a median follow-up of 10.5 month, 5 peritoneal and 2 lymph nodal recurrences were observed. Psychometric test revealed moderate discomfort in the vast majority of patients (66.7%). All patients are still alive. CONCLUSION: Invasive-IDS in patients with clinically complete response to NACT seems to be feasible and safe in terms of perioperative outcomes, psycho-oncological impact, and survival rate. The equivalence between MI surgery and laparotomy needs to be confirmed with a longer follow-up and a larger number of patients.

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.