Oncological outcomes of unexpected uterine leiomyosarcoma: A single-center retrospective analysis of 5528 consecutive hysterectomies.

BACKGROUND AND METHODS: Uterine leiomyosarcomas (uLMS) are rare malignant tumors, often incidentally discovered, with an estimated annual incidence of five cases per one million women in the United States. This study aimed to compare the oncological outcomes of two groups of patients: those with uLMS incidentally found during surgery and those who underwent surgery due to suspected or confirmed uLMS before the procedure. The study assessed patients who had undergone hysterectomy and were diagnosed with stage I uLMS at a tertiary gynecologic oncology referral center in Italy between January 2000 and December 2019. Data on patients' baseline characteristics, surgical procedures, and oncological outcomes were collected. The patients were classified into two groups based on whether uLMS was unexpectedly discovered or suspected before the surgery. Survival rates and factors influencing recurrence were analyzed. RESULTS: The study included 36 patients meeting the inclusion criteria, with 12 having preoperatively suspected or proven uLMS and 24 having incidentally discovered uLMS. No significant differences were observed between the two groups regarding disease-free survival (23.7 vs. 27.3 months, log rank = 0.28), disease-specific survival (median not reached, log rank = 0.78), or sites of relapse. Notably, among patients who underwent laparoscopic hysterectomy (compared to open surgery), a significantly higher rate of locoregional recurrence was found (78% vs. 33.3%, p = 0.04). Nevertheless, no significant differences in survival were observed based on the surgical approach. CONCLUSIONS: Preoperative suspicion for uLMS did not seem to impact survival outcomes or the pattern of recurrence. Furthermore, although patients who underwent laparoscopic hysterectomy showed a higher rate of locoregional relapse, this did not affect their overall survival.

Surgical Outcomes and Complications of Myomectomy: A Prospective Cohort Study.

STUDY OBJECTIVE: To investigate postoperative surgical and non-surgical complications that occur within 30 days following myomectomy procedures, whether laparoscopic or via open surgery. DESIGN: Prospective cohort study SETTING: Del Ponte Women's and Children's Hospital, Varese, Italy. PATIENTS: Women undergoing myomectomy either with laparoscopic or open surgery from July 2020 to June 2023 INTERVENTIONS: Data of consecutive patients who underwent abdominal myomectomy procedures, either via laparoscopy or open abdominal surgery were collected. The study examined patient characteristics, size and location of fibroids, surgical data, and complications. Univariate and multivariable analyses were employed to identify factors contributing to postoperative Clavien-Dindo grade ≥ II complications. MEASUREMENTS AND MAIN RESULTS: Overall 383 patients were included in the study. The univariate analysis showed intramural fibroid type (p = .0009), large fibroid size (p = .03), and extended operative times (p = .05) were associated with postoperative complications. Open surgical approach (p <.001) and uterine cavity opening (p = .02) also contributed to complications. Postoperative anemia emerged as the most prevalent complication. In the multivariable analysis, the open surgical approach emerged as the only independent factor associated with an increased risk of grade ≥ II complications (odds ratio 7.37; p <.0001). CONCLUSION: In this study we found an increased likelihood of complications in case of open myomectomy. While the presence of potential selection bias may have impacted this finding, it could provide valuable insights for clinicians and surgical teams in the strategic planning of myomectomy procedures.

Prevalence, Outcome, and Prevention of Congenital Cytomegalovirus Infection in Neonates Born to Women With Preconception Immunity (CHILd Study).

BACKGROUND: Human cytomegalovirus (HCMV) is the leading infectious cause of congenital disabilities. We designed a prospective study to investigate the rate, outcome, and risk factors of congenital CMV (cCMV) infection in neonates born to immune women, and the potential need and effectiveness of hygiene recommendations in this population. METHODS: The study was composed of 2 sequential parts: an epidemiology (part 1) and a prevention (part 2) study. Performance of part 2 depended upon a cCMV rate >0.4%. Women enrolled in part 1 did not receive hygiene recommendations. Newborns were screened by HCMV DNA testing in saliva and cCMV was confirmed by urine testing. RESULTS: Saliva swabs were positive for HCMV DNA in 45/9661 newborns and cCMV was confirmed in 18 cases. The rate of cCMV was .19% (95% confidence interval [CI]: .11-.29%), and 3 out of 18 infants with cCMV had symptoms of CMV at birth. Age, nationality, occupation, and contact with children were similar between mothers of infected and noninfected newborns. Twin pregnancy (odds ratio [OR]: 7.2; 95% CI: 1.7-32.2; P = .037) and maternal medical conditions (OR: 3.9; 95% CI: 1.5-10.1; P = .003) appeared associated with cCMV. Given the rate of cCMV was lower than expected, the prevention part of the study was cancelled. CONCLUSIONS: Newborns from women with preconception immunity have a low rate of cCMV, which appears to be mostly due to reactivation of the latent virus. Therefore, serological screening in childbearing age would be pivotal to identify HCMV-seropositive women, whose newborns have a low risk of cCMV. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov (NCT03973359).

Surgical Outcomes and Complications of Laparoscopic Hysterectomy for Endometriosis: A Multicentric Cohort Study.

STUDY OBJECTIVE: To investigate the postoperative morbidity of laparoscopic hysterectomy (LH) for endometriosis/adenomyosis in terms of operative outcomes and complications. DESIGN: Retrospective multicentric cohort study. SETTING: Eight European minimally invasive referral centers. PATIENTS: Data from 995 patients with pathologically confirmed endometriosis and/or adenomyosis who underwent LH without concomitant urological and/or gastroenterological procedures from January 2010 to December 2020. INTERVENTIONS: Total LH. MEASUREMENTS AND MAIN RESULTS: Demographic patients' characteristics, surgical outcomes, and intraoperative and postoperative complications were evaluated. We considered major postoperative surgical-related complications, any grade 2 or more events (Clavien-Dindo score) that occurred within 30 days from surgery. Univariate analysis and multivariable models fit with logistic regression were used to estimate the adjusted odds ratio (OR) and corresponding 95% confidence interval (CI) for major complications. Median age at surgery was 44 years (28-54), and about half of them (505, 50.7%) were on medical treatment (estro-progestins, progestin, or Gonadotropin hormone-releasing hormone-analogues) at the time of surgery. In association with LH, posterior adhesiolysis was performed in 387 (38.9%) cases and deep nodule resection in 302 (30.0%). Intraoperative complications occurred in 3% of the patients, and major postoperative complications were registered in 93 (9.3%). The multivariable analysis showed an inverse correlation between the occurrence of Clavien-Dindo >2 complications and age (OR 0.94, 95% CI 0.90-0.99), while previous surgery for endometriosis (OR 1.62, 95% CI 1.01-2.60) and intraoperative complications (OR 6.49, 95% CI 2.65-16.87) were found as predictors of major events. Medical treatment at the time of surgery has emerged as a protective factor (OR 0.50, 95% CI 0.31-0.81). CONCLUSION: LH for endometriosis/adenomyosis is associated with non-negligible morbidity. Knowing the factors associated with higher risks of complications might be used for risk stratification and could help clinicians during preoperative counseling. The administration of estro-progestin or progesterone preoperatively might reduce the risks of postoperative complications following surgery.

Hysterectomy for Non-Prolapsed Uterus in Elderly Patients: Predictors of Prolonged Hospital Stay.

OBJECTIVE: The objective of this study was to investigate surgical outcomes and complications of hysterectomy for benign conditions other than prolapse in elderly patients and to define predictors of prolonged hospitalization. DESIGN: Retrospective analysis of prospectively collected data. SETTING: This study was conducted in an academic research center. PATIENTS: We utilized our institution surgical database to identify patients aged 60 years or more ("elderly") who underwent hysterectomy for benign conditions other than pelvic organ prolapse during a 20-year period (January 2000-December 2019). METHODS: Length of stay (LOS) of more than 2 days (90th percentile of LOS) was defined as prolonged hospitalization. Patient demographics, comorbid conditions, and surgical approach (vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), and abdominal hysterectomy (AH)) were identified. Patients treated via LH or VH were also grouped as minimally invasive surgery (MIS). Multivariable logistic regression was used to identify factors associated with prolonged LOS. RESULTS: Overall, 334 patients were included in this study, 262 (78.4%) of whom underwent LH, 42 (12.6%) VH, and 30 (9.0%) AH. Median LOS was 2 days (1-8), and 63 (18.8%) patients required prolonged LOS. Compared to AH, median hospital stay was shorter in MIS group (2 days vs. 3 days, p < 0.001). No admission variables were associated with prolonged LOS. The only independent predictors of prolonged LOS were AH (odds ratio 24.82, 95% CI 4.84-127.16) and operative time (odds ratio for 30 mins increased 11.34, 95% CI 1.63-78.78). Compared to those who underwent VH, patients having LH had a higher rate of concomitant salpingo-oophorectomy (96.6% vs. 61.9%, p < 0.001). LIMITATIONS: Retrospective single-center study design, number of patients with prolonged hospitalization, and the setting (tertiary minimally invasive gynecology referral center), which might have reduced the generalizability of our results are the limitations of this study. CONCLUSIONS: The abdominal route of hysterectomy was found as the main driver of prolonged hospitalization, reinforcing the benefits of MIS for benign hysterectomy in elderly patients with non-prolapsed uteri; the higher chance of performing concomitant salpingo-oophorectomy supports the laparoscopic approach as the first option for these patients.

Evaluating long-term outcomes of three approaches to retroperitoneal staging in endometrial cancer.

OBJECTIVE: Sentinel lymph node mapping (SNM) has gained popularity in managing apparent early-stage endometrial cancer (EC). Here, we evaluated the long-term survival of three different approaches of nodal assessment. METHODS: This is a multi-institutional retrospective study evaluating long-term outcomes of EC patients having nodal assessment between 01/01/2006 and 12/31/2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm. RESULTS: Overall, 940 patients meeting inclusion criteria were included in the study, of which 174 (18.5%), 187 (19.9%), and 579 (61.6%) underwent SNM, SNM followed by backup lymphadenectomy (LND) and LND alone, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients, including 125 SNM, 125 SNM/backup LND, and 250 LND. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM/backup LND and LND, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p = 0.750) and overall survival (p = 0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification based on uterine risk factors. CONCLUSION: Our study highlighted that SNM provides similar long-term oncologic outcomes than LND.

Short-term morbidity and types of intrapartum hypoxia in the newborn with metabolic acidaemia: a retrospective cohort study.

OBJECTIVES: To assess labour characteristics in relation to the occurrence of Composite Adverse neonatal Outcome (CAO) within a cohort of fetuses with metabolic acidaemia. DESIGN: Retrospective cohort study. SETTING: Three Italian tertiary maternity units. POPULATION: 431 neonates born with acidaemia ≥36 weeks. METHODS: Intrapartum CTG traces were assigned to one of these four types of labour hypoxia: acute, subacute, gradually evolving and chronic hypoxia. The presence of CAO was defined by the occurrence of at least one of the following: Sarnat Score grade ≥2, seizures, hypothermia and death <7 days from birth. MAIN OUTCOME MEASURES: To compare the type of hypoxia on the intrapartum CTG traces among the acidaemic neonates with and without CAO. RESULTS: The occurrence of a CAO was recorded in 15.1% of neonates. At logistic regression analysis, the duration of the hypoxia was the only parameter associated with CAO in the case of an acute or subacute pattern (odds ratio [OR] 1.3; 95% CI 1.02-1.6 and OR 1.04; 95% CI 1.0-1.1, respectively), whereas both the duration of the hypoxic insult and the time from PROM to delivery were associated with CAO in those with a gradually evolving pattern (OR 1.13; 95% CI 1.01-1.3 and OR 1.04; 95% CI 1.0-1.7, respectively). The incidence of CAO was higher in fetuses with chronic antepartum hypoxia than in those showing CTG features of intrapartum hypoxia (64.7 vs. 13.0%; P < 0.001). CONCLUSIONS: The frequency of CAO seems related to the duration and the type of the hypoxic injury, being higher in fetuses showing CTG features of antepartum chronic hypoxia. TWEETABLE ABSTRACT: This study demonstrates that in a large population of neonates with metabolic acidaemia at birth, the overall incidence of short-term adverse outcome is around 15%. Such risk seems closely correlated to the duration and the type of hypoxic injury, being higher in fetuses admitted in labour with antepartum chronic hypoxia than those experiencing intrapartum hypoxia.

Outcomes of In-bag Transvaginal Extraction in a Series of 692 Laparoscopic Myomectomies: Results from a Large Retrospective Analysis.

STUDY OBJECTIVE: Transvaginal extraction is a feasible method to remove surgical specimen. In this study, we aim to report our experience with in-bag transvaginal specimen retrieval after laparoscopic myomectomy over the past 15 years. DESIGN: Single-center retrospective analysis. SETTING: Academic hospital. PATIENTS: Women who underwent laparoscopic myomectomy from January 2005 to April 2021. INTERVENTION: Posterior colpotomy and in-bag transvaginal extraction of the surgical specimen. MEASUREMENTS AND MAIN RESULTS: We collected and analyzed data about patients' characteristics, main indication for surgery, and intra- and postoperative (within 30 days) complications. RESULTS: A total of 692 women underwent transvaginal specimen retrieval after laparoscopic myomectomy (mean largest myoma diameter: 6.64 ± 2.21 cm; mean specimen weight: 177 ± 140 g; mean operative time: 84.1 ± 37.1 minutes; mean blood loss: 195 ± 191 mL). Within 30-days, we reported the following colpotomy-related complications: a total of 4 cases (0.6%) of vaginal bleeding, 3 of which resolved spontaneously (1 case required readmission with new colporrhaphy under general anesthesia), and 2 cases (0.3%) of vaginal pain, with no underlying cause identified on physical examination and pelvic ultrasound. Specimen weight was positively correlated with longer operative time, intraoperative blood loss, and length of hospital stay. CONCLUSION: Posterior colpotomy and in-bag transvaginal extraction can be considered a feasible option for retrieval of surgical specimens after laparoscopic myomectomy.

Transvaginal versus Port-Site Specimen Retrieval after Laparoscopic Myomectomy: A Systematic Review and Meta-Analysis.

INTRODUCTION: To date, there is no robust evidence suggesting whether transvaginal retrieval (TVSR) or port-site specimen retrieval (PSSR) after laparoscopic myomectomy (LM) may lead to better surgical outcomes. Considering this element, we aimed to compare surgical outcomes of TVSR versus PSSR after LM. METHODS: A search (PROSPERO ID: CRD42020176490) of international databases, from 1980 to 2020, in English language, was conducted. We selected studies that included women who underwent LM with TVSR compared with PSSR. RESULTS: We did not find significant differences for operative time (MD = -8.90; 95% CI: 30.00, 12.20; I2 = 87%), myoma retrieval time (MD = -1.85; 95% CI: 13.55, 9.85; I2 = 98%), blood loss (MD = -27.62; 95% CI: 178.68, 124.43; I2 = 91%), intra-operative complication rate (OR 0.51; 95% CI: 0.01-23.09; I2 = 69%), and hospital stay (MD = -0.14; 95% CI: 0.43, 0.15; I2 = 64%); we found a significant lower postoperative rescue analgesics utilization in the TVSR group compared with the PSSR group (OR 0.31; 95% CI: 0.16-0.61; I2 = 0). CONCLUSION: TVSR and PSSR after LM showed comparable results for operative time and surgery-related complications. However, the need of postoperative rescue analgesics was lower in women who underwent TVSR.

Tranexamic acid for the prevention and the treatment of primary postpartum haemorrhage: a systematic review.

Tranexamic acid (TA) has been proposed for preventing or treating primary postpartum haemorrhage (PPH), which is the leading cause of maternal morbidity and mortality worldwide. We conducted a systematic literature search to the TA role in managing PPH in vaginal and caesarean delivery. Twenty-seven randomised controlled trials (RCTs) (33,302 women) were identified. Three RCTs investigated TA for preventing PPH after vaginal delivery and 22 after caesarean section. None demonstrated a preventive effect on secondary clinical outcomes related to blood loss. Two trials evaluated TA for treating PPH after vaginal and caesarean delivery. Only the WOMAN trial showed that 1 g of TA is effective. In conclusion, TA is considered useful and is recommended or advised for treating PPH. Conversely, available evidence on the prophylactic role is still limited, and this use is not supported. Further investigation is recommended. In this regard, stronger and more reliable outcomes than blood loss should be considered.

Practice changes in Italian Gynaecologic Units during the COVID-19 pandemic: a survey study.

The impact of Coronavirus disease 2019 pandemic on Italian Gynaecological Units practice and the compliance and satisfaction with available guidelines/recommendations is unknown. Therefore, a survey was conducted among all Italian Gynaecological Units Directors in April 2020. The response rate was 90% (135/150). 77.8% of centres performed surgery only for oncologic or not deferrable pathologies, and 9.6% was closed. 68.7% of directors were at least moderately satisfied by published guidelines/recommendations, but 94.8% of respondents identified limitations, mainly (83%) the absent definition of benign non-deferrable pathology. Responders considered as non-deferrable severe endometriosis (69.6%), endometriosis with organ failure/dysfunction (74.1%), and unresponsive symptomatic fibroids (89.6%). Despite guidelines/recommendations, respondents treated ovarian (77%) and endometrial (71.6%) cancer as usual. Only a minority of respondents reduced the laparoscopic approach (11.2%) and adopted all recommended surgical precautions (9.6%). Compliance with available guidelines/recommendations appears incomplete. Reconsidering guidelines/recommendations regarding oncological cases and specify non-deferrable benign pathologies would improve guidelines/recommendations compliance.Impact statementWhat is already known on this subject? The SARS-CoV-2 pandemic has profoundly influenced medical routine practice worldwide. Surgery units have been forced to reduce or even completely restrict their activity to re-allocate human resources. Many major international gynaecological societies have released statements and guidelines, providing various recommendations to guide practice changes. However, the impact of the SARS-CoV-2 pandemic on Italian Gynaecological Units practice and the compliance and satisfaction with available guidelines/recommendations is unknown.What do the results of this study add? Study results provide evidence showing how the SARS-CoV-2 pandemic has changed surgical activity in the Italian Gynaecological Units. Most centres reduced surgical activity, limiting surgery only for oncologic or not deferrable pathologies. Moreover, our research shows the level of compliance and satisfaction with available guidelines/recommendations and where they need to be improved. Most directors were at least moderately satisfied but identified different limitations. Guidelines/recommendations do not provide enough details, such as the absent definition of benign non-deferrable pathologies.What are the implications of these findings for clinical practice and/or further research? The limited compliance with available guidelines/recommendations and identified limitations suggest reconsidering guidelines/recommendations focussing on identified gaps. Provide more details, such as specifying non-deferrable benign pathologies, would improve guidelines/recommendations compliance.

Minilaparoscopic single-site bilateral salpingo-oophorectomy: a scarless prophylactic procedure.

We present the first case of minilaparoscopic single-site bilateral salpingo-oophorectomy (BSO) performed as a risk-reducing procedure in a 39-year-old woman presenting with BRCA-1 mutation. Surgery was performed using only minilaparoscopic instruments inserted alternatively through two 3-mm umbilical trocars placed one next to the other. Following the BSO, specimens were retrieved within an endobag through the posterior vaginal fornix. No intraoperative or postoperative complications occurred. The patient was discharged home on the day of surgery. Thirty-day postoperative clinical evaluation was uneventful. In selected patients, the minilaparoscopic single-site approach might represent an alternative technique to minimize surgical trauma and morbidity in patients undergoing risk-reducing BSO.

Sentinel node mapping vs. sentinel node mapping plus back-up lymphadenectomy in high-risk endometrial cancer patients: Results from a multi-institutional study.

OBJECTIVE: Sentinel node mapping (SLN) has replaced lymphadenectomy for staging surgery in apparent early-stage low and intermediate risk endometrial cancer (EC). Only limited data about the adoption of SNM in high risk EC is still available. Here, we evaluate the outcomes of high-risk EC undergoing SNM (with or without back-up lymphadenectomy). METHODS: This is a multi-institutional international retrospective study, evaluating data of high-risk (FIGO grade 3 endometrioid EC with myometrial invasion >50% and non-endometrioid histology) EC patients undergoing SNM followed by back-up lymphadenectomy and SNM alone. RESULTS: Chart of consecutive 196 patients were evaluated. The study population included 83 and 113 patients with endometrioid and non-endometrioid EC, respectively. SNM alone and SNM followed by back-up lymphadenectomy were performed in 50 and 146 patients, respectively. Among patients having SNM alone, 14 (28%) were diagnosed with nodal disease. In the group of patients undergoing SNM plus back-up lymphadenectomy 34 (23.2%) were diagnosed with nodal disease via SNM. Back-up lymphadenectomy identified 2 (1%) additional patients with nodal disease (in the para-aortic area). Back-up lymphadenectomy allowed to remove adjunctive positive nodes in 16 (11%) patients. After the adoption of propensity-matched algorithm, we observed that patients undergoing SNM plus back-up lymphadenectomy experienced similar disease-free survival (p = 0.416, log-rank test) and overall survival (p = 0.940, log-rank test) than patients undergoing SLN alone. CONCLUSIONS: Although the small sample size, and the retrospective study design this study highlighted that type of nodal assessment did not impact survival outcomes in high-risk EC. Theoretically, back-up lymphadenectomy would be useful in improving the removal of positive nodes, but its therapeutic value remains controversial. Further prospective evidence is needed.

Music Therapy for Preoperative Anxiety Reduction in Women Undergoing Total Laparoscopic Hysterectomy: A Randomized Controlled Trial.

STUDY OBJECTIVE: To assess the superiority of a music therapy intervention (Music) vs usual care (Control) in reducing the preoperative anxiety of patients undergoing total laparoscopic hysterectomy (TLH) with nononcologic indications. DESIGN: This was a 1:2 (Music vs Control) randomized controlled study. SETTING: A teaching hospital. PATIENTS: One hundred patients were available for the analysis: 30 and 70 in the Music and Control arms, respectively. INTERVENTIONS: Perioperative music therapy pathway in patients undergoing TLH for benign disease. MEASUREMENTS AND MAIN RESULTS: Anxiety was evaluated with the State-Trait Anxiety Inventory Y Form (STAI-Y) at different time points: at baseline and during preoperative, early postoperative, and late postoperative periods. Pathologic anxiety was defined as STAI-Y state >45. Postoperative pain was registered using the visual analog scale. Women in the Music arm experienced lower anxiety levels (median STAI-Y scores 38.0 vs 41.0; p = .002) during the preoperative period. STAI-Y scores did not vary significantly by intervention at each subsequent time point. A significant difference between the groups (Music vs Control) was found in the proportion of women with pathologic anxiety during the preoperative (16.7% vs 37.2%; p = .04) and early postoperative periods (0% vs 12.9%; p = .04), whereas no significant difference between the groups was registered during the late postoperative period (6.6% vs 7.1%; p = .93). Postoperative pain intensity did not significantly differ between the groups at 1, 3, and 6 hours after surgery. CONCLUSIONS: Music therapy might be a viable complementary modality to usual surgical care in the gynecologic setting for its ability to significantly decrease preoperative anxiety in women undergoing TLH for benign conditions.

Preoperative Conization and Risk of Recurrence in Patients Undergoing Laparoscopic Radical Hysterectomy for Early Stage Cervical Cancer: A Multicenter Study.

STUDY OBJECTIVE: To investigate the factors associated with poorer oncologic outcomes in patients undergoing laparoscopic radical hysterectomy (LRH) for early stage cervical cancer. DESIGN: Multicenter retrospective study. SETTING: Three gynecologic oncology referral centers. PATIENTS: Patients with International Federation of Gynecology and Obstetrics 2009 stage IA (positive lymphovascular space invasion)-IB1 cervical cancer between January 2006 and June 2018. INTERVENTIONS: LRH (Piver type II-III hysterectomies). Lymph-node dissection was accomplished according to the tumor characteristics. MEASUREMENTS AND MAIN RESULTS: Surgical and oncologic outcomes were analyzed. Overall, 186 patients met the inclusion criteria, 16 (8.6%) experienced a recurrence, and 9 (4.8%) died of the disease (median follow-up period 37.9 months). Surgery-related complications did not influence disease-free survival. All the recurrences (16/16; 100%) occurred in patients with stage IB1 disease (p = .02), and 15 (93.7%) in cases involving tumors ≥2 cm. No association between positive lymph node and recurrence was detected (p =.82). Patients who had a preoperative diagnosis through conization (93; 50%) had a significantly lower rate of recurrence than those who underwent cervical biopsy (93; 50%): 1/93 (1.1%) vs 15/93 (16.1%); p <.001). The subanalysis of patients with International Federation of Gynecology and Obstetrics stage IB1 cervical cancer showed that patients undergoing preoperative conization (vs cervical biopsy) were less likely to experience a recurrence (odds ratio 0.09; 95% confidence interval 0.01-0.55). CONCLUSION: We confirmed that LRH was associated with a recurrence rate similar to that reported in the Laparoscopic Approach to Cervical Cancer trial. Tumor size ≥2 cm represents the most important risk factor influencing disease-free survival. However, we found that preoperative conization plays a potentially protective role in patients with an IB1 tumor.

Three-Dimensional Sonographic Evaluation of the Position of the Fetal Conus Medullaris at First Trimester.

OBJECTIVE: The objective of this study was to assess the position of the conus medullaris (CM) at the first trimester 3D ultrasound in a cohort of structurally normal fetuses. METHODS: This was a multicenter prospective study involving a consecutive series of structurally normal fetuses between 11 and 13 weeks of gestation (CRL between 45 and 84 mm). All fetuses were submitted to 3D transvaginal ultrasound using a sagittal view of the spine as the starting plane of acquisition. At offline analysis, the position of the CM was evaluated by 2 independent operators with a quantitative and a qualitative method: (1) the distance between the most caudal part of the CM and the distal end of the coccyx (CMCd) was measured; (2) a line perpendicular to the fetal spine joining the tip of the CM to the anterior abdominal wall was traced to determine the level of this line in relation to the umbilical cord insertion (conus to abdomen line, CAL). Interobserver agreement for the CCMd was evaluated. Linear regression analysis was used to determine the association between the CMCd and CRL, and a normal range was computed based on the best-fit model. The absence of congenital anomalies was confirmed in all cases after birth. RESULTS: In the study period between December 2019 and March 2020, 143 fetuses were recruited. In 130 fetuses (90.9%), the visualization of the CM was feasible. The mean value of the CMCd was 1.09 ± 0.16 cm. The 95% limits of agreement for the interobserver variability in measurement of the CMCd were 0.24 and 0.26 cm. The interobserver variability based on the intra-class correlation coefficient (ICC) for the CCMd was good (ICC = 0.81). We found a positive linear relationship between the CCMd and CRL. In all these fetuses, the CAL encountered the abdominal wall at or above the level of the cord insertion. CONCLUSION: In normal fetuses, the assessment of the CM position is feasible at the first trimester 3D ultrasound with a good interobserver agreement. The CM level was never found below the fetal umbilical cord insertion, while the CMCd was noted to increase according to the gestational age, confirming the "ascension" of the CM during fetal life.

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.).

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; p<0.001), birthweight (OR: 1.17, 95% CI 1.09-1.12.7 per 100 g decrease; p=0.012) and maternal ventilatory support, including either need for oxygen or CPAP (OR: 4.12, 95% CI 2.3-7.9; p=0.001) were independently associated with composite adverse fetal outcome. Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.

Selective use of episiotomy: what is the impact on perineal trauma? Results from a retrospective cohort study.

PURPOSE: To evaluate the effects of selective use of episiotomy on perineal trauma. METHODS: We performed a retrospective cohort study on consecutive vaginal deliveries from January 2010 to December 2016. From January 2010 to December 2011 episiotomy was performed liberally, based only on individual midwife/doctor's decision. Since January 2012, a shared selective use of episiotomy policy has been introduced. To evaluate the range of perineal trauma in spontaneous second-degree perineal tears, a sub-classification of second-degree lacerations has been introduced dividing them into two sub-groups: A (smaller than the average episiotomy) and B (spontaneous vaginal tear larger than the average episiotomy). The primary outcomes were the incidence and type of perineal trauma, with the proportion of type A and type B second-degree spontaneous tears under a policy of selective episiotomy. RESULTS: Deliveries not exposed to selective use of episiotomy were 1583 (Group 1), those exposed to selective use of episiotomy were 6409 (Group 2). In Group 2 episiotomy rate decreased, and incidence of intact perineum, first- and second-degree lacerations increased. The incidence of third- and fourth-degree lacerations did not change. Spontaneous second-degree lacerations occurred in 19.4% and 36.8% of women in group 1 and 2, respectively. With a selective episiotomy policy, 88.3% of second-degree tears was classified as type A. CONCLUSIONS: The selective use of episiotomy is clinically feasible and effective. This policy seems to be associated with a lower delivery-related perineal trauma as showed by the sub-classification, that could be a useful tool to monitor obstetric care.

Surgical treatment of large adnexal masses: a retrospective analysis of 330 consecutive cases.

Introduction: In the present study, perioperative outcomes of laparoscopy (LPS) were compared to open surgery (OS) for the treatment of large adnexal masses (AM).Material and methods: Retrospective observational cohort study. Data of consecutive patients who underwent ovarian cystectomy or salpingo-oophorectomy for large AM (diameter ≥10 cm) at a referral minimally invasive gynecologic center were analyzed. Propensity score match (PSM) analysis was used to minimize covariate imbalances between the two groups.Results: Overall 330 patients, 285 (86.4%) LPSs and 45 (13.6%) OSs were included. PSM showed LPS (vs. OS) to be associated with less intraoperative blood loss (mL: 131.1 ± 52.6 vs. 545.5 ± 101.2; p = .007), shorter operative time (min: 84.8 ± 77.9 vs. 123.7 ± 70.1; p < .001), but higher rate of spillage (54.5% vs. 12.1%; p < .001). Among the LPS group, a positive correlation between AM size and both conversion to open surgery and need for mini-laparotomy was found (p < .05).Conclusions: An accurate patient selection, a dedicated workup, and an appropriate counselling are mandatory before LPS for large AM. The increased risks of intraoperative spillage associated with the minimally invasive approach should be acknowledged.