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Background. To evaluate the impact of the Laparoscopic Approach to Cervical Cancer (LACC) Trial on patterns of care and surgery-related morbidity in early-stage cervical cancer. Methods. This is a retrospective, a multi-institutional study evaluating 90-day surgery-related outcomes of patients undergoing treatment for early-stage cervical cancer before (period I: 01/01/2016-06/01/2018) and after (period II: 01/01/2019-06/01/2021) the publication of the results of the LACC trial. Results. Charts of 1295 patients were evaluated: 581 (44.9%) and 714 (55.1%) before and after the publication of the LACC trial, respectively. After the publication of the LACC trial, the number of patients treated with minimally invasive radical hysterectomy decreased from 64.9% to 30.4% (p < 0.001). Overall, 90-day complications occurred in 110 (18.9%) and 119 (16.6%) patients in the period I and period II, respectively (p = 0.795). Similarly, the number of severe (grade 3 or worse) complications did not differ between the two periods (38 (6.5%) vs. 37 (5.1%); p = 0.297). Overall and severe 90-day complications were consistent between periods even evaluating stage IA (p = 0.471), IB1 (p = 0.929), and IB2 (p = 0.074), separately. Conclusions. The present investigation highlighted that in referral centers the shift from minimally invasive to open radical hysterectomy does not influence 90-day surgery-related morbidity. (c) 2022 Elsevier Inc. All rights reserved.

Objective Coronavirus disease 2019 (COVID-19) outbreak has correlated with the disruption of screening activities and diagnostic assessments. Endometrial cancer (EC) is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms. Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of EC patients. Methods This is a retrospective study involving 54 centers in Italy. We evaluated patterns of presentation and treatment of EC patients before (period 1: March 1, 2019 to February 29, 2020) and during (period 2: April 1, 2020 to March 31, 2021) the COVID-19 outbreak. Results Medical records of 5,164 EC patients have been retrieved: 2,718 and 2,446 women treated in period 1 and period 2, respectively. Surgery was the mainstay of treatment in both periods (p=0.356). Nodal assessment was omitted in 689 (27.3%) and 484 (21.2%) patients treated in period 1 and 2, respectively (p, Synopsis The prevalence of patients with early-stage endometrial cancer (EC) has been lower during coronavirus disease 2019 (COVID-19) pandemic than before its onset. Further evidence is needed to assess the impact of COVID-19 pandemic on survival outcomes of EC patients.

Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by isolated thrombocytopenia (platelet count

Pancreatic cancer is rarely diagnosed during pregnancy; it usually manifests with symptoms such as epigastric pain, vomiting, weight loss, and jaundice, rarely mimicking the hemolysis, elevated liver enzymes, and low platelet count syndrome. It has been postulated that there exists a correlation between the diagnosis of gestational diabetes mellitus and the occurrence of pancreatic cancer later in life. We conducted an expert literature review of the 31 available documented pancreatic cancer cases that were diagnosed during pregnancy. We also report pancreatic adenocarcinoma incidentally suspected in an asymptomatic woman affected by gestational diabetes mellitus; the woman was undergoing a fetal growth scan.

Introduction: The association between obesity and clinically significant prostate cancer (PCa) is still a matter of debate. In this study, we evaluated the effect of body mass index (BMI) on the prediction of pathological unfavorable disease (UD), positive surgical margins (PSMs), and biochemical recurrence (BCR) in patients with clinically localized (≤cT2c) International Society of Urological Pathology (ISUP) grade group 1 PCa at biopsy. Methods: 427 patients with ISUP grade group 1 PCa who have undergone radical prostatectomy and BMI evaluation were included. The outcome of interest was the presence of UD (defined as ISUP grade group ≥3 and pT ≥3a), PSM, and BCR. Results: Statistically significant differences resulted in comparing BMI with prostate-specific antigen (PSA) and serum testosterone levels (both p < 0.0001). Patients with UD and PSM had higher BMI values (p < 0.0001 and p = 0.006, respectively). BCR-free survival was significantly decreased in patients with higher BMI values (p < 0.0001). BMI was an independent risk factor for BCR and PSM. Receiver-operating characteristic analysis testing PSA accuracy in different BMI groups, showed that PSA had a reduced predictive value (area under the curve [AUC] = 0.535; 95% confidence interval [CI] = 0.422–0.646), in obese men compared to overweight (AUC = 0.664; 95% CI = 0.598–0.725) and normal weight patients (AUC = 0.721; 95% CI = 0.660–0.777). Conclusion: Our findings show that increased BMI is a significant predictor of UD and PSM at RP in patients with preoperative low-to intermediate-risk diseases, suggesting that BMI evaluation may be useful in a clinical setting to identify patients with favorable preoperative disease characteristics harboring high-risk PCa.

In 2011, the Society of Gynecologic Oncology of Canada encouraged physicians to discuss with their patients the risks and benefits of prophylactic bilateral salpingectomy (PBS) at the time of hysterectomy or tubal ligation for prevention of ovarian cancers (OCs). The aim of this study was to examine obstetrician-gynaecologists' knowledge, opinions and practice patterns relating to opportunistic salpingectomy in the general population. An anonymous electronic survey was sent to residents, academic and hospital staff in Italian OBGYN departments. The survey included questions on demographics, knowledge and attitudes in terms of the implementation of PBS in women at average population risk of OC. At least 80% of the 479 respondents reported performing PBS during hysterectomy for benign indications, chiefly with the intent of OC risk reduction but also to decrease the risk of reoperation and subsequent tubal pathologies. Among the 86 colleagues who do not routinely perform PBS, more than 50% stated that they have doubts regarding the benefits associated with the procedure. Most of the respondents declared that they were familiar with the literature on the topic and were aware of the data reporting the safety of the procedure, and only 21 (4.53%) had never heard of PBS. Over 40% of the respondents worked in hospitals in southern Italy. PBS as a prophylactic measure to reduce the incidence of OC is a well-known strategy among the Italian OBGYNs interviewed. Given the unequal distribution of respondents, however, wider educational initiatives should be undertaken, at least in Italy, to increase the implementation of salpingectomy among OBGYNs.

Polycystic ovary syndrome (PCOS) is the most common metabolic disorder in reproductive aged women, affecting approximately 5–15% of this population.[1]The Rotterdam Criteria [2] have been accepted ...

Objective To evaluate the misdiagnosis between endometrial biopsy and definitive surgical pathology and to assess whether the failure in recognizing preoperatively high-risk endometrial carcinoma (EC) can impact oncological outcomes. Study design A retrospective study was conducted to evaluate patients with EC diagnosed by preoperative endometrial biopsy who subsequently underwent surgical staging between 2006 and 2013 at our institution. In patients with a surgical diagnosis of high-risk EC, histotype and grade change between the endometrial biopsy and surgical specimen (discordance diagnosis) were evaluated and correlated to survival outcomes. Cox's regression model for multivariable analysis was used to evaluate the effect of several variables (age, stage, discordance in diagnosis, co-morbidities, frozen section, extensive surgical staging and adjuvant chemotherapy) on the survival rate. Results Data from 447 patients were reviewed. Among 109 women with surgical diagnosis of high-risk EC, 35 (32.1%) were preoperatively misdiagnosed. Of these 35 women, 24 (68.6%) cases were upgraded to grade 3, and 11 (3.4%) were upgraded to serous or clear cell type in the definitive specimen. The 5-year overall survival (OS; 70.2 vs. 86.8%; p =0.029), disease-specific survival (DSS; 72.5 vs. 88.2%; p =0.039) and recurrence free survival (RFS; 62.6 vs. 82.5%; p =0.024) were significantly lower in the high-risk EC patients who were preoperatively undiagnosed in the endometrial biopsy compared with patients with an appropriate preoperative histological diagnosis. Controlling for age, stage, co-morbidities, frozen section, extensive surgical staging and adjuvant chemotherapy, multivariable analysis revealed that discordance in diagnosis was associated with poorer survival outcomes. Conclusion Failure to recognize preoperatively high-risk ECs is associated with worse outcomes.

Circulating endothelial cells (CEC) represent a restricted peripheral blood (PB) cell subpopulation with high potential diagnostic value in many endothelium-involving diseases. However, whereas the interest in CEC studies has grown, the standardization level of their detection has not. Here, we undertook the task to align CEC phenotypes and counts, by standardizing a novel flow cytometry approach, within a network of six laboratories. CEC were identified as alive/nucleated/CD45negative/CD34bright/CD146positive events and enumerated in 269 healthy PB samples. Standardization was demonstrated by the achievement of low inter-laboratory Coefficients of Variation (CVL), calculated on the basis of Median Fluorescence Intensity values of the most stable antigens that allowed CEC identification and count (CVL of CD34bright on CEC ~ 30%; CVL of CD45 on Lymphocytes ~ 20%). By aggregating data acquired from all sites, CEC numbers in the healthy population were captured (medianfemale = 9.31 CEC/mL; medianmale = 11.55 CEC/mL). CEC count biological variability and method specificity were finally assessed. Results, obtained on a large population of donors, demonstrate that the established procedure might be adopted as standardized method for CEC analysis in clinical and in research settings, providing a CEC physiological baseline range, useful as starting point for their clinical monitoring in endothelial dysfunctions.

ObjectiveThe objectives of this study were to characterize the well-defined endometrial cancer (EC) type I (endometrioid [EEC] G1-G2) versus the prototype of EC type II (serous [ESC]) and to evaluate the expression of specific biomarkers differentially expressed between 2 well-defined types, in those EC subtypes (such as EEC G3) disputed between types I and II.MethodsData from 25 patients (10 EEC G1-G2, 8 EEC G3, 5 ESC, and 2 clear cell) submitted to the surgical treatment were collected. Two-dimensional electrophoresis and mass spectrometry (MS) analysis were performed on 5 EEC G1-G2 and 5 healthy endometrial samples of the same patients. Differentially expressed proteins, such as DJ-1, were validated by Western blot. In patients with EEC G1-G2, serum levels of DJ-1, an overexpressed oncoprotein related to EC pathogenesis and progression, were evaluated and then compared with levels identified in patients with ESC and healthy controls. The DJ-1 immunohistochemical (IHC) staining was performed on neoplastic and healthy endometrium collected from the same patients. The 8 stored samples of EEC G3 were submitted to DJ-1 IHC assays.ResultsThe 2-dimensional electrophoresis analysis identified 1040 protein spots differentially expressed in EEC G1-G2 compared with healthy endometrium. Forty-two spots were subjected to liquid chromatography–MS/MS analysis. Thirty-three up-regulated (like an annexin 2 [ANXA2] shorter isoform, CAPG [macrophage-capping protein], DJ-1/PARK7) and 9 down-regulated (like calreticulin and ubiquitin carboxyl-terminal hydrolase isozyme L1) proteins were identified and validated by Western blot. A significant increase in serum DJ-1 levels of EEC G1-G2 versus the healthy controls and in ESC versus EEC patients was observed. DJ-1 IHC score was significantly higher in ESC versus those EEC G1-G2. In 3 cases of EEC G3, the DJ-1 expression was similar to the ESC subtype.ConclusionsThe identification of proteins, such as DJ-1, differentially expressed, between well-defined EC types I and II allows to make a subtype-specific presurgical diagnosis and help surgeon to safely preoperatively choose a proper surgical treatment.

Objective The objective of this study is to compare ovarian function and surgical outcomes between patients affected by benign uterine pathologies submitted to total laparoscopic hysterectomy (TLH) plus salpingectomy and women in which standard TLH with adnexal preservation was performed. Methods We retrospectively compared data of 79 patients who underwent TLH plus bilateral salpingectomy (group A), with those of 79 women treated by standard TLH without adnexectomy (sTLH) (group B). Ovarian reserve modification, expressed as the difference between 3months post-operative and pre-operative values of Anti-Mullerian Hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV), was recorded for each patient. For each surgical procedure, operative time, variation of hemoglobin level (ΔHb), postoperative hospital stay, postoperative return to normal activity, and complication rate were recorded as secondary outcomes. Results According to our post-hoc analysis , this equivalence study resulted to have a statistical power of 96.8%. Significant difference was not observed between groups with respect to ΔAMH ( p = 0.35 ), ΔFSH ( p = 0.15 ), ΔAFC ( p = 0.09 ), Δ mean ovarian diameters ( p = 0.57 ) and ΔPSV ( p = 0.61 ). In addition, secondary outcomes such as operative time ( p = 0.79 ), ΔHb ( p = 0.41 ), postoperative hospital stay ( p = 0.16 ), postoperative return to normal activity ( p = 0.11 ) and complication rate also did not show any significant difference. Conclusions The addition of bilateral salpingectomy to TLH for prevention of ovarian cancer in women who do not carry a BRCA1/2 mutations do not show negative effects on the ovarian function. In addition, no perioperative complications are related to the salpingectomy step in TLH.

The aim of this study was to evaluate the improvement in catamenial chronic pelvic pain (CPP) after Gonadotropin Releasing Hormone analogue (GnRH-a) administration in women affected by adenomyosis or endometriosis. We retrospectively analysed clinical data of 63 premenopausal women with clinical suspect of adenomyosis (15 women, Group A) or endometriosis (48 women, Group B), which received GnRH-a in order to reduce CPP intensity during the time on surgery waiting list. Main outcome measures were variation of CPP intensity, numbers of days requiring analgesics and lost work productivity before and three months after GnRH-a administration. Compared to baseline, a significant decrease in CPP intensity (p < 0.05) was observed in both groups, even if this reduction was significantly higher in Group A than in Group B (p < 0.001). In both groups, moreover, a significant reduction in number of days requiring analgesics (p < 0.05) and lost work productivity (p < 0.05) was detected. In conclusion, GnRH-a administration in women with clinical suspect of adenomyosis induces a greater reduction in CPP when compared to women with endometriosis, thus representing a potential ex adiuvantibus criteria, helping TV-US in the clinical diagnosis of adenomyosis.

The aim of this retrospective study was to evaluate the efficacy of levonorgestrel intrauterine system-releasing (LNG-IUS) insertion in preventing atypical endometrial hyperplasia (AH) and endometrial cancer (EC) in symptomatic postmenopausal overweight/obese women. A total of 34 overweight/obese postmenopausal women, presenting abnormal uterine bleeding (AUB) and endometrial hyperplasia (EH), and who were submitted to LNG-IUS insertion, were identified from registry data. Endometrial histology at LNG-IUS insertion showed simple EH in 20 cases (58.8%), complex EH in 14 cases (41.2%). At 36 months, 91% of patients showed no recurrence of AUB and a significant reduction in the mean endometrial thickness (from 8.2 ± 2.2 to 3.2 ± 1.5 mm, p0.05) was observed. Histologic regression of EH was observed in 27 (79.4%) and 33 (97.5%) cases at 12 and 36 months, respectively. None of the women in which EH persisted, reported cellular atypia or cancer progression at 12 and 36 months of follow-up. LNG-IUS represents an effective treatment option to manage postmenopausal obese women affected by AUB and EH. The device seems to be able to prevent the onset of AH and EC in women at high risk. Further prospective controlled studies in a well selected group of women are needed.

Study Objective Preliminary data on the effects of prophylactic bilateral salpingectomy (PBS) show that postoperative ovarian function is preserved up to 3 months after surgery. The confirmation of PBS safety on ovarian function even many years after surgery is essential to reassure the medical community that this new strategy, recently proposed for the prevention of ovarian cancer, is at least able to avoid the risk of premature surgical menopause. We investigated whether the addition of PBS during total laparoscopic hysterectomy (TLH) causes long-term effects on ovarian function. Design An observational study (Canadian Task Force classification II-3). Setting Department of Obstetrics and Gynecology, “Magna Graecia” University, Catanzaro, Italy. Patients Seventy-nine patients who underwent TLH plus salpingectomy between September 2010 and September 2012 at our institution have been recalled to be submitted to ovarian reserve evaluation in February 2015. Eight of 79 women refused to participate in this follow-up study. Interventions The ovarian age of PBS patients has been determined through OvAge (OvAge sr., Catanzaro, Italy), a statistical model that combines antimullerian hormone, follicle-stimulating hormone, 3-dimensional antral follicle count, vascular index, flow index, and vascular flow index values. The control group consisted of a large population of 652 healthy women (with intact uterus and adnexa) previously enrolled to build the OvAge model. Comparisons between ovarian ages of PBS patients and the control group have been assessed by analysis of covariance linear statistical modeling. Measurements and Main Results The main outcome measurement was the differences in the behavior within OvAge/age relation between PBS and control women. Descriptive statistics of those 71 enrolled PBS patients are the following: age, 49.61 ± 2.15 years; OvAge, 49.22 ± 2.57 years; follicle-stimulating hormone, 43.02 ± 19.92 mU/mL; antimullerian hormone, 0.12 ± 0.20 ng/mL; 3-dimensional antral follicle count, 1.91 ± 1.28; vascular index, 2.80% ± 5.32%; flow index, 19.37 ± 5.88; and vascular flow index, 0.56 ± 1.12. Analysis of covariance disclosed that PBS and control women do not exhibit different behaviors (p = .900) within OvAge/age relation. Conclusion According to our model, the addition of PBS to TLH in the late reproductive years does not modify the ovarian age of treated women up to 3 to 5 years after surgery.

Objective To evaluate whether manualin-bag morcellation could be efficiently proposed as alternative to the uncontained power technique. Design Randomized controlled trial. Setting Academic hospital. Patient(s) One hundred fifty-two premenopausal women eligible for myomectomy were screened, and 104 were randomized. Intervention(s) Patients were randomized into two groups. In the experimental group, "in-bag" protected morcellation was performed. In the control group, patients were treated by uncontained power myoma removal. Main Outcome Measure(s) The primary endpoint was the comparison of morcellation operative time (MOT). The secondary endpoints were the comparisons of total operative time (TOT), simplicity of morcellation (as defined by the surgeon using a visual analogue scale scale), intraoperative blood loss, rate of complications, and postoperative outcomes. Result(s) A sample size of 51 per group (n = 102) was planned. Between March 2014 and January 2015, patients were randomized as follows: 53 to the experimental group and 51 to the control group. Most demographic characteristics were similar across groups. MOT was observed to be similar in both study groups (16.18 ± 8.1 vs. 14.35 ± 7.8 minutes, in the experimental and control groups, respectively). Fibroid size was identified as the principal factor influencing morcellation time (Pearson coefficient 0.484 vs. 0.581, in the experimental and control groups, respectively). No significant difference in TOT, simplicity of morcellation, delta Hb, postoperative pain, and postoperative outcomes were observed between groups. Conclusion(s) The protected manual in-bag morcellation technique represents a time-efficient and feasible alternative, which does not interfere with surgical outcomes in women undergoing laparoscopic myomectomy. Clinical Trial Registration NCT02086435.

Objective To study the effects of the wide excision of soft tissues adjacent to the ovary and fallopian tube on ovarian function and surgical outcomes in women undergoing laparoscopic bilateral prophylactic salpingectomy. Design Randomized, controlled trial. Setting Teaching hospital. Patient(s) One hundred eighty-six women undergoing laparoscopic surgery for uterine myoma (n = 143) or tubal surgical sterilization (n = 43). Intervention(s) Patients were randomly divided into two groups. In group A (n = 91), standard salpingectomy was performed. In group B (n = 95), the mesosalpinx was removed within the tubes. Prior to and 3 months after surgery, antimullerian hormone (AMH), FSH, three-dimensional antral follicle count (AFC), vascular index (VI), flow index (FI), vascular-flow index (VFI), and OvAge were recorded for each patient. Main Outcome Measure(s) Ovarian reserve modification (Δ) before and after surgery was assessed as the primary outcome. Operative time, variation of the hemoglobin level (ΔHb), postoperative hospital stay, postoperative return to normal activity, and complication rate were assessed as secondary outcomes. Result(s) No significant difference was observed between groups for ΔAMH, ΔFSH, ΔAFC, ΔVI, ΔFI, ΔVFI, and ΔOvAge. Moreover, the groups were similar for operative time, ΔHb, postoperative hospital stay, postoperative return to normal activity, and complication rate. Conclusion(s) Even when the surgical excision includes the removal of the mesosalpinx, salpingectomy does not damage the ovarian reserve. Moreover, wide salpingectomy with excision of the mesosalpinx did not alter blood loss, hospitalization stay, or return to normal activities. Clinical Trial Registration Number NCT02086370.

To understand the meaning of endometrial thickening and bleeding in postmenopausal women who had previously undergone endometrial ablation (EA).Retrospective observational study. Canadian Task Force III.Obstetrics and Gynecology Unit, Magna Graecia University, Catanzaro, Italy.Sixty-three postmenopausal women who had previously undergone EA.A retrospective evaluation of clinical charts of postmenopausal women who had a follow-up visit after EA between January 2000 and August 2014.The rates of endometrial thickening (with or without bleeding), endometrial atrophy, and cancer were determined. Postmenopausal bleeding was reported in 9 patients (14.3%). Endometrial thickening was observed in 51 patients (80.9%; mean ± SD endometrial thickness, 7.7 ± 3.0 mm). A significantly (p .05) greater number of patients with an endometrial thickness of 5 to 10 mm was observed compared with those with an endometrial thickness of5 mm or10 mm. A significant (p = .001) difference in increase in endometrial thickness was observed between patients with and without bleeding. Overall, hysteroscopy plus endometrial biopsy was scheduled in 24 patients. In all bleeding women, a histological diagnosis of endometrial atrophy was demonstrated. Concerning bleeding-free women, in 14 patients with endometrial thickening of10 mm, mucosal atrophy was detected. The only bleeding-free patient in whom an endometrial echogenic fluid collection was detected had a histological diagnosis of endometrioid endometrial cancer. Thus, patients who underwent hysteroscopy had a 95.8% rate of mucosal atrophy and a 4.2% rate of endometrial cancer. The overall cancer rate in our global population (menopause with previous EA) was 1.6%.Postmenopausal bleeding and sonographic detection of endometrial thickening in patients with previous EA are not necessarily related to a malignant disease. Nonetheless, ultrasound visualization of endometrial thickening plus an echogenic endometrial fluid collection in these patients always warrants an invasive diagnostic procedure regardless of whether or not bleeding is reported.

Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine disease among women of childbearing age. The clinical features are heterogeneous and vary in intensity. Hirsutism, menstrual disorders and infertility are the most frequent conditions observed; however, long-term complications (dyslipidemia, hypertension, cardiovascular disease, type 2 diabetes mellitus, endometrial cancer) are also often described. Each disorder may be managed by tailored strategies, employing sequential or combined pharmacological and/or non-pharmacological treatment.The authors review the drugs used for PCOS management and discuss new approaches. A systematic MEDLINE search regarding the randomized controlled trials, retrospective and observational studies about medical treatments of PCOS, the Cochrane library for reviews and also search for registered trials on ClinicalTrials.gov is performed.A uniform treatment for PCOS patients does not exist. Clinicians should perform an accurate evaluation of patients' characteristics, identifying the phenotypic target and, subsequently, the best-tailored treatment to manage one or more clinical issues. Lifestyle intervention should always be the first recommended approach unless other issues indicate that drug or hormonal interventions are superior.

Background In the last decade, both endocrine and ultrasound data have been tested to verify their usefulness for assessing ovarian reserve, but the ideal marker does not yet exist. The purpose of this study was to find, if any, a statistical advanced model able to identify a simple, easy to understand and intuitive modality for defining ovarian age by combining clinical, biochemical and 3D-ultrasonographic data. Methods This is a population-based observational study. From January 2012 to March 2014, we enrolled 652 healthy fertile women, 29 patients with clinical suspect of premature ovarian insufficiency (POI) and 29 patients with Polycystic Ovary syndrome (PCOS) at the Unit of Obstetrics & Gynecology of Magna Graecia University of Catanzaro (Italy). In all women we measured Anti Müllerian Hormone (AMH), Follicle Stimulating Hormone (FSH), Estradiol (E2), 3D Antral Follicle Count (AFC), ovarian volume, Vascular Index (VI) and Flow Index (FI) between days 1 and 4 of menstrual cycle. We applied the Generalized Linear Models (GzLM) for producing an equation combining these data to provide a ready to use information about women ovarian reserve, here called OvAge. To introduce this new variable, expression of ovarian reserve, we assumed that in healthy fertile women ovarian age is identical to chronological age. Results GzLM applied on the healthy fertile controls dataset produced the following equation OvAge = 48.05 - 3.14*AHM + 0.07*FSH - 0.77*AFC - 0.11*FI + 0.25*VI + 0.1*AMH*AFC + 0.02*FSH*AFC. This model showed a high statistical significance for each marker included in the equation. We applied the final equation on POI and PCOS datasets to test its ability of discovering significant deviation from normality and we obtained a mean of predicted ovarian age significantly different from the mean of chronological age in both groups. Conclusions OvAge is one of the first reliable attempt to create a new method able to identify a simple, easy to understand and intuitive modality for defining ovarian reserve by combining clinical, biochemical and 3D-ultrasonographic data. Although design data prove a statistical high accuracy of the model, we are going to plan a clinical validation of model reliability in predicting reproductive prognosis and distance to menopause. Electronic supplementary material The online version of this article (doi:10.1186/s13048-015-0149-z) contains supplementary material, which is available to authorized users.

Objective: To study the bone metabolism in postmenopausal women who have been treated with gonadotropin-releasing hormone agonist (GnRH-a) and tibolone. Design: Prospective, open, controlled clinical trial. Setting: Department of Gynecology and Obstetrics, University of Catanzaro, Catanzaro, Italy. Patient(s): One hundred twenty perimenopausal women with symptomatic uterine leiomyomas (groups A and B), and 40 healthy control women who underwent a normal spontaneous menopause (group C). Intervention(s): Treatment for 12 months with leuprolide acetate plus tibolone (group A) or hysterectomy with bilateral oophorectomy (group B). Main Outcome Measure(s): Lumbar spine bone mineral density (BMD) and bone turnover markers at entry into the study, after medical treatment (only group A), and 12 months after discontinuation medical treatment (group A) or after surgery (group B). The same parameters were noted in healthy women before and 12 months after menopause (retrospective control group, group C). Result(s): At the women's entry into the study, no significant difference in BMD and bone turnover markers was detected between groups A and B. In group A, no significant variation in BMD or bone turnover markers was observed 12 months after medical treatment in comparison with baseline. At 12 months after discontinuation of treatment (in women who had achieved menopause) and after surgery, we observed a statistically significant decrease in BMD and in bone turnover markers in both groups in comparison with baseline. At 12 months after they became menopausal, we also observed a statistically significant reduction in BMD and in bone turnover markers in control group C. At the same 12-month follow-up visit, a statistically significant difference in BMD and in bone turnover markers was detected when comparing groups A and B with group C. Conclusion(s): Women previously treated with GnRH-a and tibolone similar to women who are menopausal as a result of surgery, have higher bone loss after menopause.

To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone (GnRH) analog administered before laparoscopic myomectomy.Prospective, randomized, open, placebo-controlled clinical trial (Canadian Task Force classification I).University-affiliated hospital.Sixty-six women with symptomatic leiomyomas.Patients received 2 months of treatment with GnRH analog and iron plus tibolone (group A) or placebo (group B); group C received only iron. Laparoscopic myomectomy was performed after medical treatment.Uterine volume, number and volume of leiomyomas, echogenicity and volume of the largest leiomyomas, hematologic values, and myoma-related symptoms were evaluated at baseline, 1 week before, and 1 week after surgery. We observed significant (p0.05) reductions in uterine and leiomyomata volume, myoma-related symptoms, and improvement in hematologic values before surgery in groups A and B, without significant difference between groups compared with baseline values and group C. Operating time and blood loss were significantly (p0.05) lower in groups A and B, without significant difference compared with group C. After surgery, significant numbers of women in group C had worsening of hematologic values (p0.05).Adding tibolone to the GnRH analog regimen before laparoscopic myomectomy does not modify the effectiveness of GnRH analog administered alone.

Use of a progestin-releasing intrauterine device can be associated with development of persistent functional cysts. Specifically the levonorgestrel-releasing intrauterine system (LNG-IUS) may inhibit ovulation during the first few months and immediately affect the hypothalamic-pituitary-ovarian axis thereby altering follicular development and leading to the formation of ovarian cysts. The incidence of persistent ovarian follicles during LNG-IUS treatment has been reported in the range of 8%-31%. However these cysts are symptomless relatively small in size and seem to show a high rate (94%) of spontaneous resolution. The aim of the present study was to evaluate the optimal strategy to manage persistent ovarian follicles in premenopausal women fitted with the LNG-IUS through a retrospective case-series study. Institutional Review Board approval was not required and informed consent was not needed since data were collected retrospectively and did not include any personal identifying information. Patients included in the study were identified using the record charts and ultrasound findings of premenopausal women fitted with the LNG-IUS (Mirena; Bayer Italy) to manage abnormal uterine bleeding and chronic pelvic pain treated between February 12009 and December 31 2011 at the Department of Obstetrics and Gynecology University “Magna Graecia” of Catanzaro; the “Hospital Pugliese-Ciaccio” of Catanzaro; and the Oncology Center of Excellence “Tommaso Campanella” Catanzaro Italy. Among 185 women included in the study 75 (40.5%) women presented with a persistent ovarian follicle (>3 cm) at 6 months. The mean size of the follicles evaluated was 5.5 cm. However within 6 months spontaneous resolution of the persistent follicles was observed by ultrasound evaluation in all of the women. The present study provides further evidence that use of the LNG-IUS in premenopausal women can be associated with the development of persistent ovarian follicles. However the rate of spontaneous resolution appeared complete in all patients making surgical removal an unnecessary overtreatment. Considering the total rate of spontaneous resolution intense ultrasound monitoring aimed at identifying ovarian cysts is necessary in premenopausal women using the LNG-IUS. To reduce the risk of surgical overtreatment and avoid premature LNG-IUS removal and unnecessary estroprogestinic treatment when persistent ovarian follicles are detected during the course of a routine annual visit a 3-6-month ultrasound re-evaluation should be performed. These functional ovarian masses should be managed for 3-6 months with a wait-and-see approach. (full text) Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

OBJECTIVE The aggressive surgical strategy adopted for vulvar cancer is related to a high complication rate, usually consisting in infections and wound breakdown. Considering that platelet gel concentrate improves reparation of cutaneous lesions, the aim of the current retrospective study was to evaluate the efficacy of platelet gel application in women who had undergone radical surgery for vulvar cancer. MATERIALS AND METHODS We retrospectively analyzed record charts of 25 women referred to our academic departments with a diagnosis of vulvar cancer and who had undergone radical vulvectomy plus inguinofemoral lymphadenectomy between January 2007 and December 2011. During the reconstructive phase, a platelet gel was placed on the vaginal breach in 10 women (group A). In the remaining 15 patients, only surgical strategies were performed (group B). Primary outcomes were wound infection, necrosis, and/or breakdown of wounds rates; secondary outcomes were postoperative fever, hospital stay, and lastly, wound healing. RESULTS Compared to surgery alone, the platelet gel application was related to a significant decrease in wound infection (P = 0.032), necrosis of vaginal wounds (P = 0.096), and breakdown wound (P = 0.048) rates. In addition, in group A, reduction in postoperative fever rate (P < 0.001) and hospital stay (P < 0.001) were also detected. Compared to surgery alone, a faster wound healing in patients who had undergone surgery plus platelet (P < 0.001) were lastly observed. CONCLUSION In conclusion, platelet gel application before vulvar reconstruction represents an effective strategy to prevent wound breakdown after local advanced vulvar cancer surgery. However, further prospective data are needed to confirm these preliminary results.

Objective To evaluate safety and efficacy, in terms of spillage risk and ovarian tissue preservation, of mesial incision for laparoscopic dermoid cystectomy. Design Randomized controlled trial. Setting University. Patient(s) Sixty-seven women with dermoid cysts. Intervention(s) Laparoscopic dermoid cystectomy performed by mesial incision (33 patients, study group) or antimesial incision (34 patients, control group). Main Outcome Measure(s) Spillage of intracystic content rate, operative times, chemical peritonitis rate, and intraoperative blood loss (ΔHb) as primary outcomes. Postoperative ovarian reserve (ΔFSH levels, basal antral follicle number, mean ovarian diameter, and peak systolic velocity at 3 and 12 months after surgery) as secondary outcome. Result(s) Spillage of intracystic content rate and operative time were significantly lower in the study than in the control group. None developed chemical peritonitis. ΔHb was higher in the study group but not significantly. During the follow-up, median FSH values were significantly lower in the study group, with no differences in the E 2 levels. Moreover, median basal antral follicle number, median ovarian diameter, and median peak systolic velocity were significantly higher in the study group. Conclusion(s) Ovarian mesial-side incision appears to be a safe as well as tissue-sparing technique. Clinical Trial Registration Number NCT01590030.

Objective(s) : To evaluate the effects of two doses of medroxyprogesterone acetate (MPA) on uterine leiomyoma sizes and on uterine bleeding pattern in postmenopausal women treated with oral hormone replacement therapy (HRT). Study design : Thirty natural postmenopausal women affected by uterine leiomyomas were enrolled and treated with oral micronized estradiol (E 2 ) at dose of 2 mg per day, and randomized to receive in association MPA at dose of 2.5 mg daily (group A) or of 5 mg daily (group B). At the beginning of the study and after 1 year of treatment, uterine leiomyomata dimensions were measured using transvaginal ultrasonography (TV-USG). The subjects were instructed to note on a daily dairy the number and severity of abnormal uterine bleeding (AUB) episodes. Results : After 1 year of therapy, a significant changes in mean uterine leiomyomas size was observed in the group treated with higher dose of MPA. No significant differences in uterine bleeding were detected between the two groups. Conclusion(s) : In postmenopausal women with uterine leiomyomas, it is necessary to use the minimal efficacious dose of progestin during HRT because of a higher risk to increase the tumors dimensions.

Objective(s): To compare the long-term effectiveness of two different laparoscopic colposuspension procedures. Study design: Sixty women affected by genuine stress incontinence (GSI) were enrolled in a prospective randomized controlled trial (RCT) and treated by transperitoneal laparoscopic colposuspension using nonabsorbable sutures (group A) or prolene mesh fixed with tackers or staplers (group B). In each group the subjective and objective failure rates were evaluated at 12, 24, and 36 months after surgery. For the subjective evaluation patients were asked whether they had experienced urine leakage and any urine loss they reported was recorded on a visual analogue scale (VAS). The objective evaluation was performed by means of a clinical examination and multichannel urodynamic studies. The data were analyzed by the intention-to-treat method. Results: The subjective failure rate was significantly (P < 0.05) lower in group A than in group B at 12 months (3.3% versus 13.3%, respectively), 24 months (20.0% versus 36.7%, respectively), and 36 months (33.3% versus 53.3%, respectively) after surgery. The objective failure rate also differed significantly (P < 0.05) between the two groups after 12 (10.7% versus 25.0% for group A and group B, respectively), 24 (29.6% versus 57.7%, respectively), and 36 (42.3% versus 61.5%, respectively) months of follow-up. Conclusion(s): Laparoscopic colposuspension performed with sutures is more effective than laparoscopic colposuspension accomplished with the use of prolene meshes in the long term, and the use of prolene meshes should be avoided in treatment of GSI.

To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention.Randomized, controlled trial (Canadian Task Force classification I).University-affiliated department of obstetrics and gynecology.One hundred forty-one sexually active women of reproductive age.Conservative laparoscopic surgery without (group A) or with (group B) PSN.At entry and 24-months after surgical procedures, cure rates; frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain; and quality of life were evaluated. At follow-up visit, the cure rate was significantly (P0.05) higher in group B (83.3%) than in group A (53.3%). The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly (P0.05) lower in both groups compared with baseline values, and only severity was significantly (P0.05) lower in group B. A significant (P0.05) improvement in quality of life was observed after surgery in both groups and was significantly (P0.05) increased in group B compared with group A.PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis.

To evaluate the incidence of breast symptoms in a population treated with various hormone replacement therapy (HRT) regimens and to detect the variations in breast symptomatology after HRT changing to tibolone administration.This prospective placebo-controlled clinical trial was conducted on healthy women on HRT reporting breast symptoms. A questionnaire was given to each woman to detect breast symptomatology. Breast tenderness and mastalgia were evaluated using a visual analogue scale (VAS). According to the choice of the each woman with breast symptoms, the HRT was changed to tibolone (2.5 mg/day per os) or to calcium carbonate (1 tab/day, placebo group). The duration of treatment was of 12 months. After 6 and 12 months breast symptomatology was re-evaluated.Among the 600 screened women, 64 (10.7%) were suffering from breast symptomatology. After 6 and 12 months of treatment with tibolone or placebo, mean VAS score for breast tenderness and for mastalgia resulted significantly (P0.05) decreased, without differences between groups, in comparison with basal value. Only one woman had no improvement from the breast symptoms with tibolone administration.Shifting from classical HRT to tibolone is followed by a significant reduction of breast symptomatology in postmenopausal women with breast complaints similar to that obtained with treatment withdrawal.

Study Objective To compare two techniques of transperitoneal laparoscopic urethropexy. Design Prospective, randomized, open trial (Canadian Task Force classification I). Setting University-affiliated department of gynecology and obstetrics. Patients Sixty women with genuine stress incontinence. Interventions Transperitoneal laparoscopic retropubic urethropexy using nonabsorbable sutures (group A) and polypropylene mesh fixed with tacks or staples (group B). Measurements and Main Results Failure was assessed subjectively and objectively. Subjective evaluation was performed asking patients if they had urine loss and having them describe symptomatology on a visual analog scale before surgery and at each follow-up visit. Objective evaluation was by clinical examination and/or multichannel urodynamic studies. No significant differences in intraoperative and postoperative complications were observed between groups. The subjective failure rate was not significantly different between groups 3, 6, and 12 months after surgery. At 3 and 6 months the objective failure rate was not significantly different; however, at 12 months it was significantly lower in group A than in group B. Conclusion Transperitoneal laparoscopic retropubic urethropexy is more effective with sutures than with mesh.

This prospective randomized single-blind placebo-controlled clinical trial was carried out to evaluate the effects of raloxifene administration on uterine and leiomyoma sizes in premenopausal women. Ninety healthy premenopausal women affected by asymptomatic uterine leiomyomas were enrolled and treated with raloxifene at the doses of 60 mg/d (group A), 180 mg/d (group B), or placebo (group C). The duration of the treatment was 6 cycles of 28 d each. At entry and after three and six cycles, uterine and leiomyoma sizes were measured by transvaginal ultrasonography. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of the menstrual cycles and the side effects of the treatments were recorded using a daily diary. The severity of the uterine bleedings was assessed using a rank scale. Throughout the study, no significant changes were observed in uterine and leiomyoma size or in Delta size among the three groups and within each group of treatment. The length and severity of uterine bleedings was not significantly different between the three groups and within each group. In conclusion, raloxifene has no significant effect on uterine and leiomyoma size or on menstrual cycle in premenopausal women.

In this study, women with dysmenorrhea of at least 6 months' duration were recruited to a randomized, double-blind, controlled trial, which compared the effectiveness of conservative surgical treatment with treatment withpresacral neurectomy. One hundred twenty-six women with a diagnosis of dysmenorrhea caused by endometriosis who had been unresponsive to medical treatment formed the study subjects. A preoperative evaluation established a baseline for frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain. Similar measurements were made at 6 and 12 months. Pain severity was rated using a 100-point visual analog scale with 100 being the most severe pain. Patients were randomized to 1 of 2 treatment groups. Group A (n = 63) received electrocautery ablation or excision of visible pelvic endometriotic lesions, enucleation of endometriomas, and lysis of pelvic adhesions. Group B (n = 63) underwent presacral neurectomy after conservative treatment. Presacral neurectomy was performed after retraction of the sigmoid colon and vasopressin infiltration of the sacral promontory area. The presacral area was exposed and underlying tissue layers cauterized. At the periosteum, a semilunar piece of retroperitoneal tissue was dissected. Neurectomy was confirmed with pathologic examination of this tissue for evidence of nerve fiber presence. The 2 treatment groups were similar in demographic and clinical data. All laparoscopies were successfully completed with no surgical complications in either group. The length of surgery was significantly greater for those in group B (mean 123 minutes vs. 110 minutes; P ≤.05), but otherwise all operative parameters were similar. Short-term complications were minimal in both groups. No patient in group A had long-term complications. In group B, 21 and 9 women, at the 6- and 12-month visits, respectively, reported constipation. Medical therapy was successful in 15 of the 21 women at 6 months. Three patients reported urinary urgency at both the 6- and 12-month follow up. At the 6-month and 12-month visits, 83.2% and 85.6%, respectively, of the patients in group B reported either no dysmenorrhea or only light discomfort and were considered cured. In comparison, 60.3% and 57% of the women in group A were cured at 6 and 12 months, respectively (P ≤.05 for both). At each stage of endometriosis, and in women with deep rectovaginal septum endometriosis, the cure rate in group B was significantly higher compared with those in group A. Women in group A who had deep rectovaginal septum endometriosis were less likely to be cured compared with all stages of endometriosis in the same group. The severity of dysmenorrhea and dyspareunia was significantly improved at the 6- and 12-month visit in group B compared with group A, but the frequency of symptoms was similar in both groups after treatment.

High-Grade Serous Ovarian Carcinoma (HGSOC) is the predominant histotype of epithelial ovarian cancer (EOC), characterized by advanced stage at diagnosis, frequent TP53 mutation, rapid progression, and high responsiveness to platinum-based-chemotherapy. To date, standard first-line-chemotherapy in advanced EOC includes platinum salts and paclitaxel with or without bevacizumab. The major prognostic factor is the response duration from the end of the platinum-based treatment (platinum-free interval) and about 10–0 % of EOC patients bear a platinum-refractory disease or develop early resistance (platinum-free interval shorter than 6 months). On these bases, a careful selection of patients who could benefit from chemotherapy is recommended to avoid unnecessary side effects and for a better disease outcome. In this retrospective study, an immunohistochemical evaluation of Aurora Kinase A (AURKA) was performed on 41 cases of HGSOC according to platinum-status. Taking into account the number and intensity of AURKA positive cells we built a predictive score able to discriminate with high accuracy platinum-sensitive patients from platinum-resistant patients (p