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BACKGROUND: The intrauterine manipulator used during a hysterectomy for endometrial cancer has been suggested as a reason for worsening oncologic outcomes. However, only a few non-randomized retrospective studies have investigated this association. PRIMARY OBJECTIVES: To compare 4-year recurrence-free survival in the group of patients who undergo hysterectomy using an intrauterine manipulator with that of those who undergo hysterectomy without it. STUDY HYPOTHESIS: Patients with endometrial cancer who undergo laparoscopic hysterectomy performed with an intrauterine manipulator would have a lower recurrence-free survival than patients who undergo laparoscopic hysterectomy without a manipulator. TRIAL DESIGN: Multicenter, parallel arm, open-label, randomized controlled trial. MAJOR INCLUSION/EXCLUSION CRITERIA: Adult women diagnosed with apparently uterine-confined endometrial cancer of any histology are eligible. We exclude women who had synchronous or previous (<5 years) invasive cancer, had a WHO performance score >2, and had inadequate baseline organ function. PRIMARY ENDPOINTS: 4-Year recurrence-free survival defined as any relapse or death related to endometrial cancer or treatment calculated from randomization to the date of the first recurrence-free survival event. SAMPLE SIZE: With an accrual time of 4 years, a minimum follow-up length of 4 years, and a two-sided type I error of 0.05, we need to enroll 515 women per arm to have a statistical power of 80% to reject the null hypothesis (HR for recurrence=1), assuming that patients who undergo hysterectomy with the use of the intrauterine manipulator have a 3-year recurrence rate of 12.5% and without the use of the intrauterine manipulator of 8.5% (HR for recurrence=1.50), and that 5% of patients are lost at follow-up in each arm, with a median time of 24 months. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is expected in 2028, and result presentation in 2032. TRIAL REGISTRATION: ClinicalTrial.gov ID NCT05687084.
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BACKGROUND: Binder phenotype (BP) is a term used to define a form of maxillo-nasal dysplasia defined by the presence of flattened nose, verticalized nasal bones, and retrusion of the maxilla (BP triad). This facial anomaly can be associated with other anomalies in both genetic and acquired conditions as well as in isolation. This systematic review aimed to summarize the antenatal findings, maternal and obstetrics characteristics as well as the obstetrics and neonatal outcomes of all cases of BP diagnosed in utero. METHODS: According to the PRISMA statement, we conducted a systematic review of the literatures to identify all the Binder phenotype cases diagnosed antenatally. We extracted and summarized obstetrics and neonatal characteristics of each study, including our case report. MAIN FINDINGS: We identified a total of 47 cases of BP. The median gestational age at diagnosis was 23 weeks. BP was associated with other skeletal or non-skeletal anomalies in all cases apart from six confirmed to be isolated. Respiratory distress syndrome was observed in 12 neonates and in 18 cases BP was one of the clinical findings of chondrodysplasia punctata X-linked. CONCLUSION: BP is often associated with other fetal defects; however, when isolated, BP seems to have good obstetrics and neonatal outcomes. In fetuses with apparent isolated BP at midtrimester, genetic testing with fluorescence in situ hybridization (FISH) for ARSE deletion can be offered for CDPX1 diagnosis while exome sequencing may be more informative in cases where a syndromic condition is suspected. Lastly, BP per se is associated with a higher risk of respiratory distress syndrome and feeding difficulties.
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BACKGROUND: Inguinal lymph node dissection plays an important role in the management of melanoma, penile and vulval cancer. Inguinal lymph node dissection is associated with various intraoperative and postoperative complications with significant heterogeneity in classification and reporting. This lack of standardization challenges efforts to study and report inguinal lymph node dissection outcomes. The aim of this study was to devise a system to standardize the classification and reporting of inguinal lymph node dissection perioperative complications by creating a worldwide collaborative, the complications and adverse events in lymphadenectomy of the inguinal area (CALI) group. METHODS: A modified 3-round Delphi consensus approach surveyed a worldwide group of experts in inguinal lymph node dissection for melanoma, penile and vulval cancer. The group of experts included general surgeons, urologists and oncologists (gynaecological and surgical). The survey assessed expert agreement on inguinal lymph node dissection perioperative complications. Panel interrater agreement and consistency were assessed as the overall percentage agreement and Cronbach's α. RESULTS: Forty-seven experienced consultants were enrolled: 26 (55.3%) urologists, 11 (23.4%) surgical oncologists, 6 (12.8%) general surgeons and 4 (8.5%) gynaecology oncologists. Based on their expertise, 31 (66%), 10 (21.3%) and 22 (46.8%) of the participants treat penile cancer, vulval cancer and melanoma using inguinal lymph node dissection respectively; 89.4% (42 of 47) agreed with the definitions and inclusion as part of the inguinal lymph node dissection intraoperative complication group, while 93.6% (44 of 47) agreed that postoperative complications should be subclassified into five macrocategories. Unanimous agreement (100%, 37 of 37) was achieved with the final standardized classification system for reporting inguinal lymph node dissection complications in melanoma, vulval cancer and penile cancer. CONCLUSION: The complications and adverse events in lymphadenectomy of the inguinal area classification system has been developed as a tool to standardize the assessment and reporting of complications during inguinal lymph node dissection for the treatment of melanoma, vulval and penile cancer.
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Consenso , Técnica Delphi , Canal Inguinal , Excisão de Linfonodo , Melanoma , Neoplasias Penianas , Complicações Pós-Operatórias , Neoplasias Vulvares , Humanos , Excisão de Linfonodo/efeitos adversos , Excisão de Linfonodo/métodos , Feminino , Masculino , Neoplasias Penianas/cirurgia , Neoplasias Penianas/patologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Neoplasias Vulvares/cirurgia , Neoplasias Vulvares/patologia , Melanoma/cirurgia , Melanoma/patologia , Canal Inguinal/cirurgia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Endometriosis has been associated with sleep disorders, and hyperarousal appears to be involved in their pathogenesis; however, the presence of hyperarousal in the endometriosis population was never investigated. METHODS: We conducted a case-control survey study by sending a questionnaire to all endometriosis patients followed up at our Centers. Controls were recruited among the general population. The questionnaire included demographic information, symptoms and history of endometriosis, the Hyperarousal Scale (H-Scale), the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). RESULTS: A total of 847 women completed the questionnaires: 430 (50.8 %) had endometriosis, and 417 (49.2 %) were controls. Endometriosis was associated with higher H-scale score (OR 2.9, 95 % CI 2.4-3.8, p = 0.000), higher PSQI score (OR 4.3, 95 % CI 3.2-5.7, p = 0.000), and higher ISI score (OR 4.6, 95 % CI 3.5-6.1, p = 0.000) in multivariable ordinal logistic regressions analysis. With path analysis, hyperarousal (H-Scale) reported a partial mediating role in the association between endometriosis and sleep disorders. The mediation effect represented 22.3-27.8 % of the entire association between endometriosis and sleep disturbances. CONCLUSION: Endometriosis patients complaining sleep disorders may benefit by investigating the presence of hyperarousal given cognitive behavioral therapy was reported effective in improving hyperarousal and associated sleep disorders.
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Endometriose , Transtornos do Sono-Vigília , Humanos , Feminino , Endometriose/complicações , Adulto , Estudos de Casos e Controles , Transtornos do Sono-Vigília/epidemiologia , Inquéritos e Questionários , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Nível de Alerta/fisiologia , Qualidade do SonoRESUMO
INTRODUCTION: This Special Report aims to highlight the importance of tailored therapies in women with Polycystic Ovary Syndrome (PCOS), avoiding prescribing generalized or unsuitable therapies based on oral contraceptive pills (OCPs). AREAS COVERED: This article discusses the benefits and risks of OCP-based therapy, highlighting the possible undesirable effects, especially in those patients exhibiting risk factors as women with PCOS, and the importance of carefully evaluated tailored therapeutic approaches. Literature searches were performed with the use of PubMed, Google Scholar, and Web of Science between January and February 2024. EXPERT OPINION: Considering the recent re-analysis of PCOS Rotterdam Criteria by the Expert Group on Inositol in Basic and Clinical Research, and on PCOS (EGOI-PCOS), the traditional Rotterdam phenotypes can be reclassified to achieve more efficacious therapy choices. Using personalized therapies that consider the specific clinical characteristics of the patient allows to improve the management of the syndrome, thus avoiding the generalized use of OCPs, which risk treating only symptoms of PCOS rather than the underlying cause. In cases when contraceptive purpose is desired, patients may benefit from combined therapy with diet or insulin-sensitizer agents, as inositol, to rebalance the metabolic profile, thus reducing the risk of developing future complications.
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Anticoncepcionais Orais , Síndrome do Ovário Policístico , Humanos , Síndrome do Ovário Policístico/tratamento farmacológico , Feminino , Anticoncepcionais Orais/uso terapêutico , Anticoncepcionais Orais/efeitos adversos , Anticoncepcionais Orais/administração & dosagem , Fatores de Risco , Medicina de Precisão , Inositol/administração & dosagem , Inositol/uso terapêuticoRESUMO
OBJECTIVE: To compare the accuracy of available classification systems (Folpe, modified Folpe, Bennet, and Schoolmester) in predicting the behavior of uterine Perivascular Epithelioid Cell tumors (PEComas). METHODS: We reviewed the pathology registry to identify all uterine PEComas treated at our center. We conducted a systematic literature review searching electronic databases from inception to November 2023. We included all references reporting at least one case of uterine PEComa; cases associated with tuberous sclerosis complex were excluded. Patient-level data were extracted by identified records. Survival analysis was used to assess the accuracy of all proposed classification systems to classify uterine PEComas as malignant versus non-malignant. RESULTS: Six uterine PEComas were treated at our center. The literature search identified 101 uterine PEComas from 32 studies. Eighty-five out of 107 PEComas (28 studies and our series) reported enough follow-up data and details to apply all four classifications. The modified Folpe classification demonstrated the highest hazard ratio (HR) for relapse (HR:8.63; 95% confidence interval [CI] 2.06-36.1) and death due to PEComa (HR:6.8, 95%CI:0.89-51.6) for malignant versus non-malignant PEComas. Changing the cut-off of PEComa size to ≥8 cm and mitotic figures per 50 high power fields to ≥5, the HR for recurrence lowered (HR:6.26; 95% CI 2.20-17.80), but HR for death increased (HR:10.3; 95% CI 1.35-77.80). CONCLUSIONS: The modified Folpe classification was the most accurate in predicting the PEComa behavior. Changing the cut-off of PEComa size and number of mitotic figures may improve the accuracy in predicting death due to disease.
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Neoplasias de Células Epitelioides Perivasculares , Neoplasias Uterinas , Humanos , Feminino , Neoplasias de Células Epitelioides Perivasculares/patologia , Neoplasias de Células Epitelioides Perivasculares/classificação , Neoplasias Uterinas/patologia , Neoplasias Uterinas/classificação , Adulto , Pessoa de Meia-IdadeRESUMO
OBJECTIVES: The goal of this study was to evaluate the depth of myometrial invasion as a predictor of distant recurrence in patients with node-negative stage IB endometrioid endometrial cancer. METHODS: A retrospective multicenter study, including surgically staged endometrial cancer patients at Mayo Clinic, Rochester (MN, USA) between January 1999 and December 2017, and Fondazione Policlinico Universitario A. Gemelli (Rome, Italy) between March 2002 and March 2017, was conducted. Patients without lymph node assessment were excluded. The follow-up was restricted to the first 5 years following surgery. Recurrence-free survival was estimated using the Kaplan-Meier method. Cox proportional hazards models were fit to evaluate the association of clinical and pathologic characteristics with the risk of recurrence. RESULTS: Of 386 patients, the mean (SD) depth of myometrial invasion was 70.4 (13.2)%. We identified 51 recurrences (14 isolated vaginal, 37 non-vaginal); the median follow-up of the remaining patients was 4.5 (IQR 2.3-7.0) years. At univariate analysis, the risk of non-vaginal recurrence increased by 64% (95% CI 1.28 to 2.12) for every 10-unit increase in the depth of myometrial invasion. International Federation of Gynecology and Obstetrics (FIGO) grade and myometrial invasion were independent predictors of non-vaginal recurrence. The 5-year non-vaginal recurrence-free survival was 95.2% (95% CI 92.0% to 98.6%), 84.0% (95% CI 76.6% to 92.1%), and 67.1% (95% CI 54.2% to 83.0%) for subsets of patients with myometrial invasion <71% (n=207), myometrial invasion ≥71% and grade 1-2 (n=132), and myometrial invasion ≥71% and grade 3 (n=47), respectively. A total of 256 (66.3%) patients received either vaginal brachytherapy only or no adjuvant therapy. Patients who received adjuvant chemotherapy, regardless of receipt of external beam radiotherapy or vaginal brachytherapy, had an approximately 70% lower risk of any recurrence (HR adjusted for age, grade, myometrial invasion 0.31, 95% CI 0.12 to 0.85) and of non-vaginal recurrence (adjusted HR 0.32, 95% CI 0.10 to 0.99). CONCLUSION: The invasion of the outer third of the myometrium and histologic grade were found to be independent predictors of distant recurrence among patients with endometrioid, node-negative stage IB endometrial cancer. Future studies should investigate if systemic adjuvant therapy for patients with myometrial invasion of the outer third would improve outcomes.
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Carcinoma Endometrioide , Neoplasias do Endométrio , Miométrio , Invasividade Neoplásica , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Humanos , Feminino , Neoplasias do Endométrio/patologia , Neoplasias do Endométrio/terapia , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Miométrio/patologia , Carcinoma Endometrioide/patologia , Carcinoma Endometrioide/terapia , Carcinoma Endometrioide/cirurgia , Recidiva Local de Neoplasia/patologiaRESUMO
An update on the antenatal diagnosis of agenesis of ductus venosus (ADV) by differentiating the various possible types of shunts, focusing on the associated fetal anomalies, and predicting neonatal outcomes. This study reviewed the experience of two tertiary referral centers and literature. An unfavorable outcome was detected in preterm fetuses (p = 0.017), fetuses with a genetic anomaly (p = 0.046) or other associated malformations (p < 0.001). 71% of ADVs with other anomalies had an extrahepatic ADV (p = 0.002). 76% of fetuses with Fetal Growth Restriction (FGR) had an extrahepatic ADV (p = 0.025). ADV may negatively influence fetal growth in cases with extrahepatic vein drainage.
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INTRODUCTION: Several studies have shown that late- and post-term pregnancies are associated with an increased risk of perinatal morbidity and mortality. In this case, induction of labor is the recommended approach. For full-term pregnancies, various methods exist to prepare the cervix and/or commence labor. Prostaglandins serve the dual purpose of cervical ripening and labor induction, blurring the distinction between the two processes. The aim of this research was to evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies. METHODS: This was a retrospective cross-sectional study (ClinicalTrial ID: NCT06184139), including only late-term pregnancies in healthy nulliparous women carrying a single cephalic fetus with normal birthweight who underwent induction of labor with oral misoprostol. We used the oral misoprostol regimen proposed by the World Health Organization (WHO) for induction of labor in term singleton pregnancies in women who have not had a previous cesarean delivery and a Bishop score <7. The regimen was oral misoprostol in aqueous solution at the low dose of 25 µg every 2 h until a Bishop score ≥7, labor, or for a maximum of 8 doses. RESULTS: One hundred and four pregnant women underwent induction of labor with oral misoprostol for late-term pregnancy on the 290th day of gestation. Study population was divided in two groups based on age (<35 and ≥35 years) and obesity (BMI <30 and ≥30). No statistically significant differences were recorded between younger and older women. Obese women reported a longer time between the last dose of misoprostol and cervical dilation of 6 cm (p = 0.01), a longer time between the last dose of misoprostol and delivery (p = 0.04), and a higher rate of grade II vaginal lacerations (p = 0.02). CONCLUSIONS: Maternal BMI is a factor negatively influencing the efficacy of oral misoprostol for induction of labor in late-term pregnancy.
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Índice de Massa Corporal , Trabalho de Parto Induzido , Idade Materna , Misoprostol , Ocitócicos , Humanos , Feminino , Misoprostol/administração & dosagem , Trabalho de Parto Induzido/métodos , Gravidez , Estudos Retrospectivos , Estudos Transversais , Adulto , Ocitócicos/administração & dosagem , Administração Oral , Maturidade Cervical/efeitos dos fármacosRESUMO
To compare the in-hospital opioid and non-opioid analgesic use among women who underwent robotic-assisted hysterectomy (RH) vs. open (OH), vaginal (VH), or laparoscopic hysterectomy (LH). Records of women in the United States who underwent hysterectomy for benign gynecologic disease were extracted from the Premier Healthcare Database (2013-2019). Propensity score methods were used to create three 1:1 matched cohorts stratified in inpatients [RH vs. OH (N = 16,821 pairs), RH vs. VH (N = 6149), RH vs. LH (N = 11,250)] and outpatients [RH vs. OH (N = 3139), RH vs. VH (N = 29,954), RH vs. LH (N = 85,040)]. Opioid doses were converted to morphine milligram equivalents (MME). Within matched cohorts, opioid and non-opioid analgesic use was compared. On the day of surgery, the percentage of patients who received opioids differed only for outpatients who underwent RH vs. LH or VH (maximum difference = 1%; p < 0.001). RH was associated with lower total doses of opioids in all matched cohorts (each p < 0.001), with the largest difference observed between RH and OH: median (IQR) of 47.5 (25.0-90.0) vs. 82.5 (36.0-137.0) MME among inpatients and 39.3 (19.5-66.0) vs. 60.0 (35.0-113.3) among outpatients. After the day of surgery, fewer inpatients who underwent RH received opioids vs. OH (78.7 vs. 87.5%; p < 0.001) or LH (78.6 vs. 80.6%; p < 0.001). The median MME was lower for RH (15.0; 7.5-33.5) versus OH (22.5; 15.0-55.0; p < 0.001). Minor differences were observed for non-opioid analgesics. RH was associated with lower in-hospital opioid use than OH, whereas the same magnitude of difference was not observed for RH vs. LH or VH.
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Analgésicos Opioides , Histerectomia , Dor Pós-Operatória , Procedimentos Cirúrgicos Robóticos , Humanos , Feminino , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/administração & dosagem , Procedimentos Cirúrgicos Robóticos/métodos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Histerectomia/métodos , Estados Unidos , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Adulto , Doenças dos Genitais Femininos/cirurgia , Doenças dos Genitais Femininos/tratamento farmacológico , Analgésicos não Narcóticos/uso terapêutico , Analgésicos não Narcóticos/administração & dosagem , Laparoscopia/métodos , Laparoscopia/estatística & dados numéricos , Pontuação de PropensãoRESUMO
OBJECTIVE: To present a new surgical technique on the basis of an internal thigh fasciocutaneous flap for generating a compliant and sensitive neovagina with preservation of the external genitalia. DESIGN: Video demonstration of the surgical steps. PATIENT(S): An 18-year-old woman with Müllerian agenesis confirmed at ultrasound and magnetic resonance imaging. The residual vagina was 3 cm long and 1.5 cm wide. After counseling by a gynecologist and plastic surgeon, in which all available techniques with pros and cons were exposed, the patient opted for the new technique. The long time required by conservative approaches and the desire to preserve the external genitalia with the chance to have a sensitive vagina guided the choice. INTERVENTION(S): The cul-de-sac of the vaginal stump was incised transversally. A 4-cm-wide and 9-cm-long canal bounded anteriorly by the bladder, posteriorly by the rectum, and superiorly by the peritoneum of Douglas was developed by blunt dissection. Fasciocutaneous flaps of 12 per 5 cm on the anteromedial aspect of the thighs were developed, identifying the vascular-from the pudendal artery-and nervous pedicles. A tunnel between the flap pedicles and neovagina introitus was created between fascia and subcutaneous tissue, detaching the vulvar structures from the ischiopubic ramus. Flaps were tunneled up to the neovagina introitus and sutured together by interrupted suture to form a tube with outside skin. The flaps were transposed into the canal everting the tube to obtain the skin lining the internal neovagina. The inferior margins of the flaps were sutured to the vaginal stump mucosa. No internal stitches were placed. Antibiotic prophylaxis was used during surgery. The entire procedure lasted 6 hours. During the postoperative period, no special positioning or ambulation restrictions were used. MAIN OUTCOME MEASURE(S): Compliance and sensitivity of the neovagina, esthetic result, and perioperative and long-term complications. RESULT(S): The postoperative course was uneventful, with early mobilization. The length of hospital stay was 16 days to allow proper vaginal dilator use; initial daily followed by intermittent use was planned. At a 2-year follow-up, the neovagina was sensitive and patent, allowing sexual intercourse. No complications were reported, and the patient was satisfied with the functional and esthetic result. CONCLUSION(S): The new surgical technique was feasible and effective, preserving the external genitalia and avoiding graft healing and bowel secretion drawbacks without an intra-abdominal surgical step and related risks. However, more cases-2 cases performed to date with similar results-and long-term follow-up are needed to confirm the efficacy. In this regard, the regular use of vaginal dilators and forecast adherence between flaps and the connective tissue of the bladder and rectum are expected to prevent neovagina prolapse without any anchoring to the pelvic structures.
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Transtornos 46, XX do Desenvolvimento Sexual , Ductos Paramesonéfricos , Retalhos Cirúrgicos , Vagina , Humanos , Feminino , Vagina/cirurgia , Vagina/anormalidades , Adolescente , Ductos Paramesonéfricos/anormalidades , Ductos Paramesonéfricos/cirurgia , Transtornos 46, XX do Desenvolvimento Sexual/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Anormalidades Congênitas/cirurgia , Estruturas Criadas Cirurgicamente , Procedimentos Cirúrgicos em Ginecologia/métodos , Resultado do TratamentoRESUMO
No prospective study has validated molecular classification to guide adjuvant treatment in endometrial cancer (EC), and not even retrospective data are present for patients with morphological low-risk EC. We conducted a retrospective, multicenter, observational study including 370 patients with low-risk endometrioid EC to evaluate the incidence and prognostic role of p53 abnormal expression (p53abn) in this specific subgroup. Among 370 patients, 18 had abnormal expressions of p53 (4.9%). In 13 out of 370 patients (3.6%), recurrences were observed and two were p53abn. When adjusting for median follow-up time, the odds ratio (OR) for recurrence among those with p53abn versus p53 wild type (p53wt) was 5.23-CI 95% 0.98-27.95, p = 0.053. The most common site of recurrence was the vaginal cuff (46.2%). One recurrence occurred within the first year of follow-up, and the patient exhibited p53abn. Both 1-year and 2-year DFS rates were 94.4% and 100% in the p53abn and p53wt groups, respectively. One patient died from the disease and comprised p53wt. No difference in OS was registered between the two groups; the median OS was 21.9 months (16.4-30.1). Larger multicenter studies are needed to tailor the treatment of low-risk EC patients with p53abn. Performing molecular classification on all EC patients might be cost-effective, and despite the limits of our relatively small sample, p53abn patients seem to be at greater risk of recurrence, especially locally and after two years since diagnosis.
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OBJECTIVE: The aim of the study was to evaluate the diagnostic accuracy for parametria endometriosis (PE) of transvaginal sonography (TVS) performed following a systematic approach for the assessment of the lateral parametria. DESIGN: A diagnostic accuracy study was employed based on a prospective observational design. PARTICIPANTS: All consecutive patients who underwent laparoscopic surgery for endometriosis between January 2016 and December 2020 were considered. SETTING: The study was conducted at endometriosis referral hospitals. METHODS: We prospectively collected clinical, imaging, and surgical data of all consecutive patients who underwent laparoscopic surgery for endometriosis between January 2016 and December 2020. A standardized technique with a systematic approach for the assessment of the lateral parametria following specific anatomic landmarks was used for the TVS. The diagnostic accuracy for PE in TVS was assessed using the intraoperative and pathologic diagnosis of PE as the gold standard. RESULTS: In 476 patients who underwent surgery, PE was identified in 114 out of 476 patients (23.95%): 91 left and 54 right PE out of 476 surgical procedures were identified (19.12% vs. 11.34%; p = 0.001); bilateral involvement in 27.19% (31/114 patients) cases. The sensitivity of TVS for PE was 90.74% (79.70-96.92%, 95% CI) for the right side and 87.91% (79.40-93.81%, 95% CI) for the left side. The specificity was almost identical for both sides (98.58% vs. 98.18%). For the right parametrium, the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 63.82 (28.70-141.90, 95% CI) and 0.09 (0.04-0.22, 95% CI), respectively. On the left parametrium, the PLR and NLR were 48.35 (23.12-101.4, 95% CI) and 0.12 (0.07-0.21, 95% CI), respectively. The diagnostic accuracy for right and left PE was 97.69% (95.90-98.84%, 95% CI) and 96.22% (94.04-97.74%, 95% CI), respectively. LIMITATIONS: The principal limit is the high dependence of TVS on the operator experience. Therefore, although a standardized approach following precise definitions of anatomical landmarks was used, we cannot conclude that the observed accuracy of TVS for PE is the same for all sonographers. In this regard, the learning curve was not assessed. In the case of negative TVS for parametrial involvement with an absent intraoperative suspect, a complete dissection of the parametrium was not performed to avoid surgical complications; therefore, cases of minor PE may be missed, underestimating false negatives. CONCLUSIONS: TVS performed following a systematic approach for assessing the lateral parametria seems to have good diagnostic accuracy for PE with large changes in the posttest probability of parametrial involvement based on the TVS evaluation. Considering the clinical and surgical implications of PE, further studies implementing a standardized approach for assessing the parametrium by TVS are recommended to confirm our observations and implement a standardized protocol in clinical practice.
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Endometriose , Laparoscopia , Feminino , Humanos , Endometriose/diagnóstico por imagem , Endometriose/cirurgia , Ultrassonografia/métodos , Sensibilidade e Especificidade , Vagina/diagnóstico por imagem , Vagina/cirurgia , Vagina/patologiaRESUMO
STUDY OBJECTIVE: To evaluate recurrence rate and pattern in apparently early-stage endometrial cancer (EC) treated with minimally invasive surgery (MIS) and compare it to the "historical" populations treated by laparotomy. Secondary outcomes were to establish if, among MIS recurrent patients, intermediate-high/high-risk patients presented the same recurrence pattern compared to those at low/intermediate-risk and to evaluate time to first recurrence (TTR) of the study population. DESIGN: Multicenter retrospective observational study. SETTING: Five Italian Gynecologic Oncology referral centers. PATIENTS: All patients with proven recurrence of apparently early-stage EC treated with MIS from January 2017 to June 2022 . The laparotomic historical cohort was obtained from Laparoscopy Compared With Laparotomy for Comprehensive Surgical Staging of Uterine Cancer: Gynecologic Oncology Group Study (LAP2) and Laparoscopic Approach to Cancer of the Endometrium trials. INTERVENTIONS: Evaluation of recurrence rate and pattern. MEASUREMENTS AND MAIN RESULTS: Seventy-seven recurrences occurred on the total of 1028 patients treated with MIS for apparently early-stage EC during a median follow-up time of 36 months. The rate of recurrence in our cohort did not differ significantly from the rate of the historical cohort (7.4% vs 7.9%, odds ratio 0.9395, 95% CI 0.6901-1.2792). No significant differences were noticed for local, abdominal, nodal, and multiple site recurrence patterns; distant site recurrence appeared more likely in patients from the historical cohort. Postoperative low/intermediate risk patients had a higher likelihood of local recurrence compared to intermediate-high/high risk patients. Mean TTR was 19 months. No significant difference of TTR was observed for each pattern of recurrence compared to others. CONCLUSION: MIS appears to be safe for the treatment of early-stage EC. We did not identify any recurrence pattern specifically associated with MIS in early-stage EC.
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Neoplasias do Endométrio , Laparoscopia , Humanos , Feminino , Neoplasias do Endométrio/cirurgia , Neoplasias do Endométrio/patologia , Estudos Retrospectivos , Histerectomia , Laparotomia/efeitos adversos , Laparoscopia/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos , Estadiamento de Neoplasias , Recidiva Local de Neoplasia/cirurgiaRESUMO
BACKGROUND: Previous reviews on hysterectomy versus uterine-sparing surgery in pelvic organ prolapse (POP) repair did not consider that the open abdominal approach or transvaginal mesh use have been largely abandoned. OBJECTIVES: To provide up-to-date evidence by examining only studies investigating techniques currently in use for POP repair. SEARCH STRATEGY: MEDLINE and Embase databases were searched from inception to January 2023. SELECTION CRITERIA: We included randomized and non-randomized studies comparing surgical procedures for POP with or without concomitant hysterectomy. Studies describing open abdominal approaches or transvaginal mesh implantation were excluded. DATA COLLECTION AND ANALYSIS: A random effect meta-analysis was conducted on extracted data reporting pooled mean differences and odds ratios (OR) between groups with 95% confidence intervals (CI). MAIN RESULTS: Thirty-eight studies were included. Hysterectomy and uterine-sparing procedures did not differ in reoperation rate (OR 0.93; 95% CI 0.74-1.17), intraoperative major (OR 1.34; 95% CI 0.79-2.26) and minor (OR 1.38; 95% CI 0.79-2.4) complications, postoperative major (OR 1.42; 95% CI 0.85-2.37) and minor (OR 1.18; 95% CI 0.9-1.53) complications, and objective (OR 1.38; 95% CI 0.92-2.07) or subjective (OR 1.23; 95% CI 0.8-1.88) success. Uterine preservation was associated with a shorter operative time (-22.7 min; 95% CI -16.92 to -28.51 min), shorter hospital stay (-0.35 days, 95% CI -0.04 to -0.65 days), and less blood loss (-61.7 mL; 95% CI -31.3 to -92.1 mL). When only studies using a laparoscopic approach for both arms were considered, no differences were observed in investigated outcomes between the two groups. CONCLUSIONS: No major differences were observed in POP outcomes between procedures with and without concomitant hysterectomy. The decision to preserve or remove the uterus should be tailored on individual factors.
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Histerectomia , Tratamentos com Preservação do Órgão , Prolapso de Órgão Pélvico , Humanos , Feminino , Prolapso de Órgão Pélvico/cirurgia , Histerectomia/métodos , Histerectomia/efeitos adversos , Tratamentos com Preservação do Órgão/métodos , Complicações Pós-Operatórias/epidemiologia , Útero/cirurgia , Reoperação/estatística & dados numéricos , Duração da CirurgiaRESUMO
OBJECTIVE: This study aimed to assess the effects on oncologic outcomes of intrauterine manipulator use during laparoscopic hysterectomy for endometrial cancer. DATA SOURCES: A systematic literature search was performed by an expert librarian in multiple electronic databases from inception to January 31, 2023. STUDY ELIGIBILITY CRITERIA: We included all studies in the English language that compared oncologic outcomes (recurrence-free, cause-specific, or overall survival) between endometrial cancer patients who underwent total laparoscopic or robotic hysterectomy for endometrial cancer with vs without the use of an intrauterine manipulator. Studies comparing only peritoneal cytology status or lymphovascular space invasion were summarized for completeness. No selection criteria were applied to the study design. METHODS: Four reviewers independently reviewed studies for inclusion, assessed their risk of bias, and extracted data. Pooled hazard ratios with 95% confidence intervals were estimated for oncologic outcomes using the random effect model. Heterogeneity was quantified using the I2 tests. Publication bias was assessed by funnel plot and Egger test. RESULTS: Out of 350 identified references, we included 2 randomized controlled trials and 12 observational studies for a total of 14 studies and 5,019 patients. The use of an intrauterine manipulator during hysterectomy for endometrial cancer was associated with a pooled hazard ratio for recurrence of 1.52 (95% confidence interval, 0.99-2.33; P=.05; I2=31%; chi square P value=.22). Pooled hazard ratio for recurrence was 1.48 (95% confidence interval, 0.25-8.76; P=.62; I2=67%; chi square P value=.08) when only randomized controlled trials were considered. Pooled hazard ratio for overall survival was 1.07 (95% confidence interval, 0.65-1.76; P=0.79; I2=44%; chi square P value=.17). The rate of positive peritoneal cytology or lymphovascular space invasion did not differ using an intrauterine manipulator. CONCLUSION: Intrauterine manipulator use during hysterectomy for endometrial cancer was neither significantly associated with recurrence-free and overall survival nor with positive peritoneal cytology or lymphovascular space invasion, but further prospective studies are needed.