Publications by authors named "Antonio Schiattarella"

40 Publications

A Standardized Evaluation Method for Assessing Patients With Genital Dyschromia.

Cureus 2021 Jun 22;13(6):e15840. Epub 2021 Jun 22.

Medicine, Bahiana School of Medicine and Public Health, Salvador, BRA.

Objective The population's ever-growing concern with genital aesthetic dysfunctions reflects an increasing demand in the field of intimate aesthetics. For this reason, as well as the lack of a standardized evaluation, this paper aims to develop a form that facilitates the initial investigation of aesthetic genital dysfunctions.  Methods An evaluation form for female and male genital dyschromia was developed between July and November 2018. Following initial development, the form was evaluated for quality and was updated by a panel of specialists (a psychologist, two pelvic dysfunction physiotherapists, and two dermato-functional physiotherapists) via email and through a content validity questionnaire. The face validity of the form was assessed by five physiotherapy and medical students who were randomly selected. The students answered a questionnaire evaluating the proposed form. The reliability of the form was established through the test-retest procedure by evaluating its reproducibility over time. Results The "Genital Dyschromia Evaluation Form'' (composed of identification, anamnesis, and physical examination sections) was approved by the specialist panel. They suggested questions to be added in the anamnesis (dermatological lesions or fungal and bacterial infections) and physical examination (hyperemia, edema in the perianal and internal thigh region) sections. As for the image analysis, an increase in quality, resolution, and sharpness was suggested. Lastly, for the cutaneous phototype evaluation, the DoctorSkinFototipo® digital analyzer device was chosen since it is small, portable, easily positioned on the genital area, and can be readily cleaned between patients.  Conclusion The "Genital Dyschromia Evaluation Form" is a questionnaire approved by specialists and could represent a suitable option for health professionals.
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http://dx.doi.org/10.7759/cureus.15840DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298189PMC
June 2021

Safety of non-hormonal medications for managing hot flashes.

Expert Opin Drug Saf 2021 Jul 28:1-7. Epub 2021 Jul 28.

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

: Menopausal complaints are a critical aspect of women's lives. In particular vasomotor symptoms, such as hot flashes, may seriously impact quality of life and are considered the most bothersome complaint by patients. Although Menopausal Hormone Therapy (MHT) is considered the best option, women increasingly ask for a natural and more tailored treatment approach.: Nutraceutical compounds represent the most widespread alternative therapy for vasomotor symptoms, and their use is somewhat increasing. In this review, the authors analyzed the mechanism of action and the related safety of non-hormonal treatments, including new approaches and future aspects.: MHT represents the traditional therapy for menopausal complaints, especially for severe and moderate symptoms; however, evidence has not defined a safety profile for all patients. To address this issue, nutraceuticals could represent a compelling and useful non-hormonal approach in selected patients.
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http://dx.doi.org/10.1080/14740338.2021.1960310DOI Listing
July 2021

Timing of delivery and blood pressure cut-off in chronic hypertension during pregnancy: State of art and new proposals.

Int J Gynaecol Obstet 2021 Jun 23. Epub 2021 Jun 23.

Department of Obstetrics and Gynecology, New York Health and Hospitals/Lincoln, Bronx, NY, USA.

Objective: Pregnant women with chronic hypertension are recommended to deliver at 36-39  weeks. The American College of Cardiology and American Heart Association in 2017 lowered the blood pressure cut-off for stage I hypertension to 130/80 mm Hg.

Methods: We performed a literature review on studies comparing elective induction of labor versus expectant management in pregnant women with chronic hypertension. In addition, we reviewed fetal and maternal outcomes in pregnant women with blood pressure of 120-139/80-89 or 130-139/80-89 mm Hg.

Results: We found two randomized clinical trials and one retrospective observational study comparing elective delivery of pregnant women with chronic hypertension versus expectant management. The randomized trials favored expectant management and the observational study favored induction of labor. We found 15 retrospective cohort studies analyzing maternal and fetal outcomes in pregnant women with blood pressure cut-off lower than 140/90 mm Hg. There was a consistent finding of increased risk of any hypertensive disorder of pregnancy, gestational diabetes mellitus, and small-for-gestational-age neonate.

Conclusion: Randomized clinical trials are needed to assess the appropriate timing of delivery for women with stage I hypertension with a blood pressure cut-off of 130/80 mm Hg.
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http://dx.doi.org/10.1002/ijgo.13794DOI Listing
June 2021

Efficacy of phloroglucinol in shortening the first stage of labor: systematic review and meta-analysis of randomized controlled trials.

J Matern Fetal Neonatal Med 2021 Jun 8:1-7. Epub 2021 Jun 8.

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Background: Protracted labor is associated with an elevated risk of maternal and fetal complications. Results of randomized controlled trials on the efficacy in labor of phloroglucinol (PHL), a pure antispasmodic drug, are uncertain.

Objectives: To evaluate whether PHL is effective in shortening the first stage of labor.

Search Strategy: MEDLINE, EMBASE, LILACS, Scopus, ClinicalTrials.gov, and the Cochrane Library were searched from inception to July 2020.

Selection Criteria: Randomized controlled trials (RCTs) concerning women with a singleton vertex pregnancy at term who were treated with PHL.

Data Collection And Analysis: Relevant data were extracted and tabulated. Review Manager 5.3 was used for data analysis. Primary outcome evaluated was the mean reduction of the first stage of labor.

Main Results: Five RCTs, including 487 pregnant women, were analyzed. The first stage of labor duration was significantly shorter in the treatment arm compared to the control group [MD-113.21 min (95% CI-119.63,-106.79)]. A significant shortening of the second stage was achieved in the PHL group [MD-11.12 min (95% CI-12.64,-9.75)] while no differences were reported for the third stage.

Conclusions: PHL might represent an effective treatment to shorten the duration of the first and second stage of labor.

Synopsis: A meta-analysis of 5 trials found that Phloroglucinol favorably impacts on the total duration of the labor in primiparae and multiparae women with a singleton pregnancy.
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http://dx.doi.org/10.1080/14767058.2021.1936488DOI Listing
June 2021

Aberrant right subclavian artery: the association with chromosomal defects and the related post-natal outcomes in a third level referral centre.

J Obstet Gynaecol 2021 May 27:1-5. Epub 2021 May 27.

Pediatric Cardiology Unit, Monaldi Hospital, University "Luigi Vanvitelli", Naples, Italy.

Aberrant right subclavian artery (ARSA) is the most common embryologic abnormality of the aortic arch. The presence of ARSA has been previously associated with an increased risk of Down syndrome. ARSA at birth may be associated with dysphagia, respiratory distress and stridor and there is no clear evidence-based management. The aim of this study was to describe the associations with chromosomal abnormalities and the postnatal outcome of fetuses diagnosed with ARSA. We analysed fetuses diagnosed antenatally with ARSA between January 2013 and September 2019 in the fetal echocardiography unit of the Hospital Monaldi, University 'Vanvitelli' of Naples, Italy. The results showed fifty fetuses diagnosed with ARSA, all confirmed after birth. The ARSA was an isolated finding in 46 fetuses (92%), while in 4 fetuses the ARSA was associated with other cardiac and/or extra-cardiac anomalies. Only one fetus was diagnosed with trisomy 21 (2%). In this fetus the ARSA was the only ultrasound anomaly identified. There were no cases necessitating referral due to the presence of compression symptoms at birth. The presence of ARSA was associated with trisomy 21 in the 2% of cases in our series and there were no neonatal complications due to airway compression at birth.IMPACT STATEMENT Aberrant right subclavian artery (ARSA) is the most common embryologic abnormality of the aortich arch. ARSA at birth could be associated with dysphagia, respiratory distress and stridor and no evidence-based management of these fetuses has been described yet. The presence of ARSA has been previously associated with an increased risk of Down syndrome. This study confirms known data on association with chromosomal defects and provides some original data on the absence of symptomatology due to tracheal compression with a postnatal follow-up up to three years of age. Our findings suggest that in cases with adequate prenatal assessment performed by experienced clinicians, delivery can safely take place at local hospitals, with no need of referral soon after birth. The use of transthoracic echocardiography to confirm the diagnoses of ARSA after birth and to plan the next follow-up appointments can be supported.
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http://dx.doi.org/10.1080/01443615.2021.1904228DOI Listing
May 2021

The Impact of a Plant-Based Diet on Gestational Diabetes: A Review.

Antioxidants (Basel) 2021 Apr 2;10(4). Epub 2021 Apr 2.

Independent Researcher, Via Venezuela 66, 98121 Messina, Italy.

Gestational diabetes mellitus (GDM) represents a challenging pregnancy complication in which women present a state of glucose intolerance. GDM has been associated with various obstetric complications, such as polyhydramnios, preterm delivery, and increased cesarean delivery rate. Moreover, the fetus could suffer from congenital malformation, macrosomia, neonatal respiratory distress syndrome, and intrauterine death. It has been speculated that inflammatory markers such as tumor necrosis factor-alpha (TNF-α), interleukin (IL) 6, and C-reactive protein (CRP) impact on endothelium dysfunction and insulin resistance and contribute to the pathogenesis of GDM. Nutritional patterns enriched with plant-derived foods, such as a low glycemic or Mediterranean diet, might favorably impact on the incidence of GDM. A high intake of vegetables, fibers, and fruits seems to decrease inflammation by enhancing antioxidant compounds. This aspect contributes to improving insulin efficacy and metabolic control and could provide maternal and neonatal health benefits. Our review aims to deepen the understanding of the impact of a plant-based diet on oxidative stress in GDM.
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http://dx.doi.org/10.3390/antiox10040557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8065523PMC
April 2021

Abnormal uterine bleeding types according to the PALM-COEIN FIGO classification in a medically underserved American community

J Turk Ger Gynecol Assoc 2021 05 26;22(2):91-96. Epub 2021 Feb 26.

Department of Obstetrics and Gynecology, New York City Health and Hospitals/Lincoln, New York, United States of America

Objective: To describe the distribution of abnormal uterine bleeding (AUB) type according to the polyp (AUB-P); adenomyosis (AUB-A); leiomyoma (AUB-L); malignancy and hyperplasia (AUB-M); coagulopathy (AUB-C); ovulatory dysfunction (AUB-O); endometrial (AUB-E); iatrogenic (AUB-I); and not yet classified International Federation of Gynecology and Obstetrics classification system in a medically underserved American inner-city population. Our secondary objective was to find an association between risk factors and type of AUB.

Material And Methods: We conducted a descriptive cross-sectional analysis at our outpatient women’s health clinic located in the Bronx, New York City, from November 2016 to December 2019.

Results: Among 390 patients, the most common AUB type was AUB-L (n=185, 47.4%), followed AUB-P (n=100, 25.6%), AUB-A (n=55, 14.1%), AUB-O (n=19, 4.9%), AUB-M (n=15, 3.8%), AUB-E (n=14, 3.6%) and AUB-I (n=2, 0.5%). Race was distributed as follows: Hispanic (68.2%), Black (25.9%), Caucasian (3.3%), and Asian (2.1%). Comorbidities included hypertension (36.4%), diabetes (15.6%), and thyroid disease (6.9%). The median age at diagnosis was significantly higher in AUB-M (59 years old, p<0.001), AUB-P (52.5 years old, p<0.001), AUB-E (51.5 years old, p=0.001) compared to AUB-L (46 years old). The median body mass index (BMI) was significantly higher in AUB-E (34.2 kg/m, p=0.048) and AUB-O (32.6 kg/m, p=0.038) compared to AUB-L (30 kg/m). Race was equally distributed among the AUB types. AUB-M (66.6%, p=0.002), AUB-E (57.1%, p=0.022), AUB-P (47%, p<0.001), and AUB-A (30.8%, p<0.001), had statistically significantly more cases of hypertension compared to AUB-L (28.1%). AUB-P (27%, p<0.001), AUB-M (26.6%, p=0.025), AUB-E (35.7%, p=0.001) and AUB-A (9%, p<0.001) had more patients with diabetes mellitus (DM) than AUB-L (3.3%).

Conclusion: In an American population of medically underserved patients, the most common cause of AUB was leiomyoma and the most common race was Hispanic. Women with AUB-L were younger, with lower BMI, and with fewer cases of hypertension and DM when compared to other types of AUB.
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http://dx.doi.org/10.4274/jtgga.galenos.2021.2020.0228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187974PMC
May 2021

Maternal and perinatal outcomes in high compared to low risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection (phase 2): the World Association of Perinatal Medicine working group on coronavirus disease 2019.

Am J Obstet Gynecol MFM 2021 07 20;3(4):100329. Epub 2021 Feb 20.

Department of Obstetrics and Gynecology, Centre for High-Risk Pregnancy and Fetal Care, University of Chieti, Chieti, Italy (Dr Liberati, Dr Sebastiano, Dr Oronzi, Dr Cerra, and Dr Buca).

Background: It has still to be ascertained whether severe acute respiratory syndrome coronavirus 2 infection in pregnancy is associated with worse maternal and fetal outcomes compared to low risk gestations.

Objective: This study aimed to evaluate maternal and perinatal outcomes in high- and low-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection.

Study Design: This was a multinational retrospective cohort study involving women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection from 76 centers from 25 countries in Europe, the United States, South America, Asia, and Australia from April 4, 2020, to October 28, 2020. The primary outcome was a composite measure of maternal mortality and morbidity, including admission to the intensive care unit, use of mechanical ventilation, or death. The secondary outcome was a composite measure of adverse perinatal outcome, including miscarriage, fetal loss, neonatal and perinatal death, and admission to the neonatal intensive care unit. All outcomes were assessed in high- and low-risk pregnancies. Pregnancies were considered high risk in case of either preexisting chronic medical conditions in pregnancy or obstetrical disorders occurring in pregnancy. The Fisher exact test and logistic regression analysis were used to analyze the data.

Results: A total of 887 singleton pregnancies who tested positive for severe acute respiratory syndrome coronavirus 2 infection using reverse transcription-polymerase chain reaction of nasal and pharyngeal swab specimens were included in the study. The risk of composite adverse maternal outcomes was higher in high-risk pregnancies than in low-risk pregnancies (odds ratio, 1.52; 95% confidence interval, 1.03-2.24; P=.035). In addition, women carrying high-risk pregnancies were at higher risk of hospital admission (odds ratio, 1.48; 95% confidence interval, 1.07-2.04; P=.002), presence of severe respiratory symptoms (odds ratio, 2.13; 95% confidence interval, 0.41-3.21; P=.001), admission to the intensive care unit (odds ratio, 2.63; 95% confidence interval, 1.42-4.88), and invasive mechanical ventilation (odds ratio, 2.65; 95% confidence interval, 1.19-5.94; P=.002). When exploring perinatal outcomes, high-risk pregnancies were at high risk of adverse perinatal outcomes (odds ratio, 1.78; 95% confidence interval, 0.15-2.72; P=.009). However, such association was mainly because of the higher incidence of miscarriage in high-risk pregnancies compared with that in low-risk pregnancies (5.3% vs 1.6%, P=.008); furthermore, there was no difference in other explored outcomes between the 2 study groups. At logistic regression analysis, maternal age (odds ratio, 1.12; 95% confidence interval, 1.02-1.22; P=.023) and high-risk pregnancy (odds ratio, 4.21; 95% confidence interval, 3.90-5.11; P<.001) were independently associated with adverse maternal outcomes.

Conclusion: High-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection were at higher risk of adverse maternal outcomes than low-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7896113PMC
July 2021

Mediterranean Diet for the Prevention of Gestational Diabetes in the Covid-19 Era: Implications of Il-6 In Diabesity.

Int J Mol Sci 2021 Jan 26;22(3). Epub 2021 Jan 26.

Research Centre for Food and Nutrition, Council for Agricultural Research and Economics (CREA-AN), 00178 Rome, Italy.

The aim of this review is to highlight the influence of the Mediterranean Diet (MedDiet) on Gestational Diabetes Mellitus (GDM) and Gestational Weight Gain (GWG) during the COVID-19 pandemic era and the specific role of interleukin (IL)-6 in diabesity. It is known that diabetes, high body mass index, high glycated hemoglobin and raised serum IL-6 levels are predictive of poor outcomes in coronavirus disease 2019 (COVID-19). The immunopathological mechanisms of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection include rising levels of several cytokines and in particular IL-6. The latter is associated with hyperglycemia and insulin resistance and could be useful for predicting the development of GDM. Rich in omega-3 polyunsaturated fatty acids, vitamins, and minerals, MedDiet improves the immune system and could modulate IL-6, C reactive protein and Nuclear Factor (NF)-κB. Moreover, polyphenols could modulate microbiota composition, inhibit the NF-κB pathway, lower IL-6, and upregulate antioxidant enzymes. Finally, adhering to the MedDiet prior to and during pregnancy could have a protective effect, reducing GWG and the risk of GDM, as well as improving the immune response to viral infections such as COVID-19.
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http://dx.doi.org/10.3390/ijms22031213DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7866163PMC
January 2021

Treatment of COVID-19 in Pregnancy with Hydroxychloroquine and Azithromycin: a case report.

Acta Biomed 2020 07 16;91(4):e2020123. Epub 2020 Jul 16.

Department of Plastic Surgery, Cleveland Clinic, Ohio, USA.

The combination of hydroxychloroquine (HCQ) and azithromycin could represent a suitable treatment for SarS-CoV-2 positive pregnancies. The authors report one of the first cases of COVID-19 positive pregnant woman successfully treated with HCQ in April 2020.
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http://dx.doi.org/10.23750/abm.v91i4.10216DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927503PMC
July 2020

Usefulness of atosiban for tocolysis during external cephalic version: Systematic review and meta-analysis.

Eur J Obstet Gynecol Reprod Biol 2021 Mar 31;258:86-92. Epub 2020 Dec 31.

Department of Woman, Child, and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Introduction: Breech/transverse presentation is responsible for about 30-50 % of cesarean sections in the world. Cesarean section carries a five-fold greater morbidity than vaginal delivery, deeply impacting on women's health. External Cephalic Version (ECV) is an external manipulation used to convert a non-cephalic to a cephalic presentation. The use of tocolysis might facilitate this procedure; however, it is still controversial which drug should be considered as first choice.

Objective: To assess the effectiveness of tocolysis with atosiban, a competitive oxytocin receptor antagonist, in order to increase the rate of successful ECV.

Study Design: Nine databases (including MEDLINE, CINAHL, LILACS, EMBASE, Scopus, ClinicalTrials.gov, Scielo, PROSPERO, Cochrane at CENTRAL) were searched from the inception to August 2020 using a combination of MeSH terms and keywords regarding "atosiban" and "external cephalic version". We included trials of women with a singleton pregnancy who reached at least 36 weeks of gestation and were scheduled to ECV and tocolysis with atosiban (intervention group) compared to beta-agonists or other drugs (control group). The primary outcome was the incidence of successful ECV. Summary measures were reported as relative risk (RR) with 95 % confidence interval (CI).

Data Collection And Analysis: Four studies (1534 women) were eligible for analysis. ECV success rate was significantly lower in women randomized to atosiban (36.7 % vs 45.3 %; RR 0.78 [95 % CI 0.6 to 0.98]). Cesarean section and vaginal delivery rates did not differ between intervention and control group ((59.8 % vs 52.6 %; RR 1.17 [0.98-1.38] and (38.6 % vs 45.0 %; RR 0.83 [95 % CI 0.69-1.01] respectively). Cephalic (36.9 % vs 44.6 %; RR 0.81 [95 % CI 0.65 to 1.01], or breech/transverse presentation at labor (63.4 % vs 55.1 %; RR 1.18 [95 % CI 0.99-1.40]), APGAR score less than 7 at 5 min (1.6 % vs 2.0 %; RR 1.14 [95 % CI 0.27-4.73], NICU admissions (44.2 % vs 48.1 %; RR 0.92 [95 % CI 0.58-1.46] and Umbilical cord pH were similar in both groups. Drug-related side effects were lower in women randomized to atosiban, compared with control group (16.0 % vs 42.9 %; RR 0.38 [95 % CI 0.31 to 0.47].

Conclusion: The use of atosiban for tocolysis does not improve the rate of successful ECVs when compared to beta-agonists. However, atosiban was associated with a significantly lower incidence of side effects and comparable cesarean section rates.
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http://dx.doi.org/10.1016/j.ejogrb.2020.12.053DOI Listing
March 2021

Transversus abdominis plane block versus wound infiltration for post-cesarean section analgesia: A systematic review and meta-analysis of randomized controlled trials.

Int J Gynaecol Obstet 2021 Jun 11;153(3):383-392. Epub 2021 Feb 11.

Obstetrics and Gynecology Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Background: Transversus abdominis plane (TAP) block and wound infiltration (WI) with local anesthetics are used for postoperative analgesia after cesarean section (CS), reducing the need for administration of opioids.

Objective: To compare the analgesic effect of TAP block related to WI.

Search Strategy: MEDLINE, Scopus, ClinicalTrials.gov, EMBASE, Cochrane Library, and CINAHL were searched from inception until April 2020.

Selection Criteria: Randomized controlled trials (RCTs) about women who underwent TAP block or WI after CS.

Data Collection And Analysis: Relevant data were extracted and tabulated. Review Manager 5.3 was used for data analysis. Primary outcome was cumulative opioid consumption (COC) 24 and 48 h after CS.

Main Results: Five RCTs, enrolling 268 women, were included. There were no significant differences between the interventions regarding COC at 24 (mean difference [MD] -1.68, 95% confidence interval [CI] -6.29 to 2.93) and 48 hours (MD 1.28, 95% CI -10.44 to 13.00). Adverse effects (relative risk [RR] 0.93, 95% CI 0.75-1.16), gastrointestinal reactions (RR 1.30, 95% CI 0.46-3.68), or mild-moderate sedation (RR 1.12, 95% CI 0.72-1.74), pain scores, satisfaction of women, and withdrawals were similar between groups.

Conclusions: There might be no significant advantages selecting TAP block over WI for post-CS analgesia.
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http://dx.doi.org/10.1002/ijgo.13563DOI Listing
June 2021

Surgical and Reproductive Outcomes after Hysteroscopic Removal of Retained Products of Conception: A Systematic Review and Meta-analysis.

J Minim Invasive Gynecol 2021 02 6;28(2):204-217. Epub 2020 Nov 6.

Department of Woman, Child and General and Specialized Surgery, Obstetrics and Gynecology Unit, University of Campania, Luigi Vanvitelli, Naples, Italy (Drs. Stefano Cianci, Antonio Schiattarella, Gaetano Riemma, Pasquale De Franciscis).

Objective: To evaluate the impact of hysteroscopy for retained products of conception (RPOC) removal on surgical and reproductive outcomes.

Data Sources: Electronic databases (MEDLINE, Scopus, ClinicalTrials.gov, SciELO, EMBASE, and the Cochrane Central Register of Controlled Trials at the Cochrane Library) were searched from inception to March 2020.

Methods Of Study Selection: Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analysis of Observational Studies in Epidemiology guidelines were followed. Medical Subject Headings terms and text words such as "retained products of conception," "placental remnants," "placenta," and "hysteroscopy" were used for the identification of relevant studies. We included observational and randomized studies that analyzed surgical and/or reproductive outcomes of women who underwent hysteroscopic removal of RPOC. The primary outcome was the complete resection rate after 1 procedure.

Tabulation, Integration, And Results: Twenty out of 245 studies were applicable, with data provided for 2112 women. The pooled complete resection rate was 91% (95% confidence interval [CI], 0.83-0.96). The incomplete resection rate evaluated was 7% (95% CI, 0.03-0.14), with a complication rate of 2% (95% CI, 0.00-0.04). Out of 1478 procedures, only 12 cases (0.8%) of postsurgical intrauterine adhesions were reported. Regarding post-therapy fecundity, women attempting postoperative conception had a clinical pregnancy rate of 87% (95% CI, 0.75-0.95), with a live birth rate of 71% (95% CI, 0.60-0.81) and a pregnancy loss rate of 9% (95% CI, 0.06-0.12).

Conclusion: Hysteroscopy has a high rate of completely removing RPOC in a single surgical step, with low complication rates. Subsequent fecundity seems reassuring, with appropriate clinical pregnancy and live birth rates. However, standardization of approach and comparative trials of different hysteroscopic approaches are needed.
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http://dx.doi.org/10.1016/j.jmig.2020.10.028DOI Listing
February 2021

Prevention and treatment of cystitis during menopause: efficacy of a nutraceutical containing D-mannose, inulin, cranberry, bearberry, and .

Prz Menopauzalny 2020 Sep 2;19(3):130-134. Epub 2020 Oct 2.

Unit of Gynecology and Obstetrics, Rummo Hospital, Benevento, Italy.

Aim Of The Study: To evaluate the efficacy of a nutraceutical compound containing Uticlin® (D-mannose, cranberry, bearberry, ), inulin, and , in preventing recurrent urinary tract infections (UTIs) in menopausal women.

Material And Methods: This was a prospective cohort study of menopausal women recruited with a history of recurrent UTIs in the previous twelve months and who intended to treat their bladder problem without the use of antibiotics and/or anti-inflammatories. Women were proposed the use of an oral nutraceutical compound. The drug was taken for ten days, every month. Women were assigned to two parallel cohorts: patients using (group 1) or not using (group 2) this nutraceutical compound. The primary objective of the study was to evaluate the number of women with less than two infective episodes in the 6-month follow-up and less than three episodes in the 12-month follow-up. The secondary endpoints were to evaluate the reduction of related symptoms at 12-month follow-up, according to the Visual Analog Scale (VAS).

Results: At 6 months of therapy, the reduction in the number of patients with ≥ 2 UTIs was statistically significant ( < 0.05) compared to baseline only in group 1. At 12 months, the number of patients who were disease-free was significantly higher ( < 0.05) in group 1 compared to group 2. Moreover, the improvement of related symptoms was statistically significant ( < 0.05) in group 1, as shown by the reduction in the VAS scale value.

Conclusions: In menopausal women, the combination of D-mannose, inulin, cranberry, bearberry, and SGL 11 per os represents a useful therapy for recurrent UTIs in women wanting a natural approach.
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http://dx.doi.org/10.5114/pm.2020.99567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573332PMC
September 2020

Is Uterine Myomectomy a Real Contraindication to Vaginal Delivery? Results from a Prospective Study.

J Invest Surg 2020 Oct 26:1-6. Epub 2020 Oct 26.

Obstetrics and Gynecology Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Objectives: The main goal of our research was to explore correlations between a history of uterine myomectomy and maternal-fetal outcomes, throughout a comparison between vaginal deliveries in patients with or without a history of uterine myoma excision.

Materials And Methods: A prospective study was carried out at two tertiary care hospitals between January 2019 and January 2020. Women were assigned into two groups according to the history of laparoscopic or laparotomic myomectomy (Group 1) or without myomectomy (Group 2).

Results: 80 women successfully delivered after myomectomy. Pregnancies with previous laparoscopic or laparotomic myomectomy were associated with a minor rate of spontaneous labor onset (RR 1.17; 95% CI 1.04 - 1.31) and with an increased rate of emergency cesarean section (RR 1.22; 95% CI 1.09 - 1.36). Moreover, myomectomy group had a significant number of indications to emergency cesarean section correlated to suspected uterine rupture (RR 1.19; 95% CI 1.02-1.39). There were no uterine ruptures or neonatal deaths recorded. First stage of labor was longer in the myomectomy group (316 vs 204 mins, p = 0.01). No differences in the rates of the prolonged first and second stage of labor, postpartum hemorrhage and vaginal laceration, and no neonatal adverse outcomes were found between groups.

Conclusions: Pregnancies after myomectomy might be associated with an elevated rate of emergency cesarean section only due to a higher percentage of suspected uterine rupture, without a real hazard of adverse obstetric or neonatal outcomes.
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http://dx.doi.org/10.1080/08941939.2020.1836289DOI Listing
October 2020

Hysteroscopic and ultrasonographic evaluation of ulipristal acetate treatment for symptomatic myomas in premenopausal women: a prospective study.

Minim Invasive Ther Allied Technol 2020 Oct 12:1-6. Epub 2020 Oct 12.

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Objective: This study aimed to analyze the effects of a six-month therapy with ulipristal acetate (UPA) on myoma size and endometrial thickness in premenopausal women.

Material And Methods: Seventy-four women undergoing conservative therapy with UPA were enrolled for this study. All women underwent transvaginal ultrasound evaluation to assess the endometrial thickness, and the number and size of myomas at the beginning and after six months. Hysteroscopy and biopsy were performed after six months, if necessary.

Results: After six months of treatment, sonographic examination showed a statistically significant ( < .05) reduction of the size of the largest myoma (56.3 ± 5.1 vs. 31.7 ± 10.1 mm) and a statistically significant ( < .05) increase in endometrial thickness (5.9 ± 2.1 vs. 9.7 ± 3.4 mm). Twenty-two patients with endometrial thickness >10 mm or nonhomogeneous pattern and ten patients with metrorrhagia underwent hysteroscopy: the most frequent finding was the combination of endometrial hypotrophy, floating surface, and chicken-wire vascular pattern aspect (14 cases, 43.7%). Histologic findings showed no case of complex hyperplasia.

Conclusion: UPA is a safe, effective and assured method to decrease symptoms, reduce the need for surgery in premenopausal women suitable for the treatment.
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http://dx.doi.org/10.1080/13645706.2020.1829648DOI Listing
October 2020

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.

J Perinat Med 2020 11;48(9):950-958

Department of Obstetrics and Gynaecology, Ospedale di San Leonardo, Castellammare di Stabia, Italy.

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.
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http://dx.doi.org/10.1515/jpm-2020-0355DOI Listing
November 2020

Hyperthermic intraperitoneal chemotherapy (HIPEC) for ovarian cancer recurrence: systematic review and meta-analysis.

Gland Surg 2020 Aug;9(4):1140-1148

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Background: Ovarian cancer is the first cause of death among gynecological malignancies with a high incidence of recurrence. Different treatment options are suitable to prolong the survival rate of these patients. Over the last years, one of the most intriguing methods, adopted in different oncologic centers worldwide, is the hyperthermic intraperitoneal chemotherapy (HIPEC).

Methods: A meta-analysis was performed to value the role of HIPEC for ovarian cancer recurrence. Search strategy was conducted with a combination of the following keywords: "ovarian recurrence, ovarian cancer recurrence, peritoneal cancer recurrence, ovarian recurrence AND HIPEC, secondary cytoreduction HIPEC". Seven studies were selected for analysis.

Results: In women with recurrent ovarian cancer (ROC), the use of HIPEC in addition to cytoreductive surgery and chemotherapy significantly improved 1-year overall survival (OS) when compared to protocols without HIPEC (OR 2.42; 95% CI, 1.06-5.56; P=0.04; I=4%). The improvement in OS was maintained significant also after 2, 3 and 5 years respectively (OR 3.33; 95% CI, 1.81-6.10; P<0.01; I=0%), (OR 4.22; 95% CI, 2.07-8.60; P<0.01; I=52%), (OR 5.17; 95% CI, 1.40-19.09; P=0.01; I=82%).

Conclusions: HIPEC seems to have an effective role to prolong survival in patients affected by ROC.
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http://dx.doi.org/10.21037/gs-20-335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475376PMC
August 2020

Elevated transaminases in a COVID-19 positive patient at term of gestation: a case report.

Acta Biomed 2020 09 7;91(3):e2020002. Epub 2020 Sep 7.

Array.

Background: The coronavirus disease 2019 (COVID-19) pandemic is caused by the severe acute respiratory syndrome 2 virus (SARS-CoV-2) and it is spreading worldwide with an alarming high transmission rate. SARS-CoV-2 usually attacks the lungs causing a wide range of symptoms ranging from mild dyspnea to severe shortness of breath requiring intubation. Elevation of liver transaminases in the patients' sera has been described in up to 53% of the COVID-19 positive patients. The underlying pathogenic mechanisms of the virus on the liver cells are unclear and only few hypotheses are currently available. Data on COVID-19 in pregnant women are lacking and the management of COVID-19 pregnant women is challenging. An elevation of the transaminases during pregnancies infected by SARS-CoV-2 has never been described before.

Methods: Here we presented the case of a 29 years-old patient at 38 weeks of gestation COVID-19 positive with elevated transaminases.

Results: The patient showed a progressive decrease of transaminases after the delivery of the fetus. We provided details about the daily transaminases trend, the therapy used and the maternal/neonatal outcomes.

Conclusions: We speculate that in our case the delivery of the fetus contributed to the normalization of the liver enzymes. In patients affected by COVID-19, at term of gestation, with elevated transaminases, delivery of the fetus is an appealing option. If confirmed by larger studies, our proposed management might be incorporated in the obstetrical management guidelines for COVID-19 positive patients.
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http://dx.doi.org/10.23750/abm.v91i3.9796DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717025PMC
September 2020

Intrauterine transmission of COVID-19 in Pregnancy: case report and review of literature.

Acta Biomed 2020 09 7;91(3):e2020041. Epub 2020 Sep 7.

Department of Obstetrics and Gynecology, New York Health and Hospitals/Lincoln, Bronx, NY USA.

We report the first case of SARS-CoV-2 pregnancy in the U.S. Our literature review highlights the rarity of COVID-19 intrauterine transmission and the need for clinicians to promptly test neonates born to SARS-CoV-2 positive mothers at delivery for COVID-19. It is imperative to establish the real risk of intrauterine transmission and to develop appropriate preventive and treatment strategies.
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http://dx.doi.org/10.23750/abm.v91i3.9795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717029PMC
September 2020

Non-hormonal Treatments For Menopausal Symptoms and Sleep Disturbances: A Comparison Between Purified Pollen Extracts and Soy Isoflavones.

Curr Pharm Des 2020 ;26(35):4509-4514

Obstetrics and Gynecology Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli”, Naples, Italy

Background: Besides hot-flushes, sleep disturbances increase around menopause, impacting on the quality of life. When hormone replacement therapy is contraindicated, it is necessary to provide alternative treatments.

Objectives: This study aimed to observe the effects of an herbal remedy from pollen extracts and soy isoflavones for menopausal complaints, particularly on sleep disorders.

Methods: A six-month prospective observational study was performed in women in natural menopause suffering from menopausal symptoms and sleep disturbances. Three groups were compared: 57 women receiving two tablets/ day containing herbal remedy from pollen extracts (group A), 60 women receiving one tablet/day containing isoflavones 60 mg (group B), 47 women not receiving any treatment (group C). At 3 (T3) and 6 months (T6), the daily number of hot-flushes, Kupperman index for menopausal symptoms, the Pittsburgh Sleep Quality Index (PSQI) test were assessed.

Results: Both groups A and B showed a significant improvement of hot flushes (p<0.001) and Kuppermann Index (p<0.001) from T0 to T3 and from T0 to T6. No significant differences between treatment groups were found at T3, while at T6 group A showed greater decrease of daily hot flashes and better improvement of Kupperman Index as compared to group B (respectively, -48.8% versus -18.4% and -24.4% versus -15.4%; p<0.001). Improvement of global sleep quality was more evident in the pollen treated group compared to isoflavones group at both three (-24.7% versus -9.3%, p<0.001) and six (-52.9% vs -4.0%; p<0.001) months, mainly for the scores related to subjective sleep quality, sleep latency and habitual sleep efficiency.

Conclusion: Non-hormonal treatments can effectively be used in symptomatic menopausal women: among these, after six months of treatment, pollen extracts might achieve a better improvement of hot flushes, sleep disturbances and menopause-related symptoms than soy isoflavones. Herbal remedy from pollen extracts is mainly effective when the quality of sleep is the most disturbing complaint.
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http://dx.doi.org/10.2174/1381612826666200721002022DOI Listing
February 2021

Une masse utérine impressionnante : un cas de lipoléiomyome.

J Obstet Gynaecol Can 2020 Jul 9. Epub 2020 Jul 9.

Department of Woman, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italie; Complex Operative Unit - Obstetrics and Gynecology, Sant'Anna e San Sebastiano Hospital, Caserta, Italie.

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http://dx.doi.org/10.1016/j.jogc.2020.04.009DOI Listing
July 2020

An impressive uterine mass: A case of a lipoleiomyoma.

J Obstet Gynaecol Can 2020 Jul 9. Epub 2020 Jul 9.

Department of Woman, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, 80138 Naples, Italy; Complex Operative Unit - Obstetrics and Gynecology, Sant'Anna e San Sebastiano Hospital, 81100 Caserta, Italy.

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http://dx.doi.org/10.1016/j.jogc.2020.03.019DOI Listing
July 2020

Efficacy of hyoscine butyl-bromide in shortening the active phase of labor: Systematic review and meta-analysis of randomized trials.

Eur J Obstet Gynecol Reprod Biol 2020 Sep 23;252:218-224. Epub 2020 Jun 23.

Department of Woman, Child, and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Introduction: Prolonged labor increases the risk of maternal and fetal complications. The active management of labor has been proven effective in lowering neonatal and maternal morbidity by shortening the duration of labor. Several pharmaceutical and non-pharmaceutical approaches are currently being used in the active management of labor. Hyoscine Butyl-bromide (HBB) is an antispasmodic and anticholinergic drug that acts as a cervical spasmolytic agent. It has been widely used in everyday practice for shortening the active phase of labor. Nonetheless, only a few trials have been conducted on the topic.

Objective: This review aimed to evaluate whether HBB is effective in decreasing the mean duration of the active phase of labor.

Study Design: An electronic search was conducted on Medline (through PubMed), Scopus, ClinicalTrials.gov, EMBASE, PROSPERO, and Cochrane Library from the beginning of all databases to December 2019. Results were limited to randomized trials. Restriction for English language was applied. Inclusion criteria were: randomized clinical trials regarding primiparae or multiparae women with a singleton vertex pregnancy at term who were randomized to HBB versus placebo or other drugs. Primary outcome evaluated was the mean reduction of the active phase of labor.

Data Collection And Analysis: Eight randomized clinical trials, including 1159 pregnant women, were analyzed. Significant heterogeneity (I = 99 %) between studies was noted for the primary outcome. The active phase of labor duration was significantly reduced in the treatment arm compared to controls [mean difference (MD) -83.93 min (95 % confidence interval (CI) -163.61, -4.25)]. Achieved reduction in primiparae women was -55.09 min [95 % CI -68.83, -41.35; I = 37 %].

Conclusion: HBB is an effective treatment to shorten the duration of the active phase of labor in primiparae and multiparae women.
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http://dx.doi.org/10.1016/j.ejogrb.2020.06.042DOI Listing
September 2020

Cas exceptionnel d'endométriome ombilical primitif sanglant (nodule de Villar).

J Obstet Gynaecol Can 2021 03 27;43(3):282. Epub 2020 May 27.

Department of Woman, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italie.

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http://dx.doi.org/10.1016/j.jogc.2020.02.005DOI Listing
March 2021

An Exceptional Case of a Bloody Primary Umbilical Endometrioma (Villar's Nodule).

J Obstet Gynaecol Can 2021 03 27;43(3):281. Epub 2020 May 27.

Department of Woman, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italy.

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http://dx.doi.org/10.1016/j.jogc.2019.07.004DOI Listing
March 2021

Fertility preservation in women affected by gynaecological cancer: the importance of an integrated gynaecological and psychological approach.

Ecancermedicalscience 2020 6;14:1035. Epub 2020 May 6.

Department of Woman, Child and General and Specialised Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.

Gynaecological cancer treatment significantly affects the fertility of women in reproductive age. Surgery, chemotherapy and radiotherapy are the mainstays of ovarian, cervical and endometrial cancers and anatomically or functionally impact the uterus and ovaries. Moreover, the sexual function and psychological wellbeing of patients are highly weakened after a cancer diagnosis: depression, anxiety and impairment of quality of life represent a relevant concern for patient care. The potential loss of fertility could be more distressing than cancer itself. For this reason, it is of paramount importance to try to preserve fertility in women affected by gynaecological cancers. Recently, tailored fertility preservation therapies have been developed to meet the childbearing demand from more than half of women between 18 and 40 years with a diagnosis of cancer. Currently, fertility preservation techniques play a significant role in improving the quality of life of women with gynaecological cancer. In this scenario, we propose a narrative overview of the recent literature about the importance of a multidisciplinary approach in the management of fertility preservation in the case of gynaecological cancers.
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http://dx.doi.org/10.3332/ecancer.2020.1035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221134PMC
May 2020

Impact of Hysteroscopic Metroplasty on Reproductive Outcomes of Women with a Dysmorphic Uterus and Recurrent Miscarriages: A Systematic Review and Meta-Analysis.

J Gynecol Obstet Hum Reprod 2020 Sep 21;49(7):101763. Epub 2020 Apr 21.

Department of Woman, Child and General and Specialized Surgery, Obstetrics and Gynecology Unit, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.

The aim of this systematic literature review and meta-analysis is to assess the impact of hysteroscopic metroplasty for dysmorphic uteri on reproductive outcomes in women with recurrent miscarriages. Available studies were identified through a PubMed, Scopus, and Cochrane search until June 2019. Live-birth rate, clinical pregnancy and miscarriage rate after hysteroscopic metroplasty was evaluated. DerSimonian and Laird's random-effect model was used for relative risks, Freeman-Tukey Double Arcsine for pooled estimates and exact method to stabilize variances and CIs. Heterogeneity was quantified using I2-statistics. Six out of 164 published studies met the inclusion criteria. All (n = 221) women underwent metroplasty, using 5Fr-hysteroscope with bipolar electrodes or 26Fr/28Fr-resectoscope in outpatient or inpatient settings. After 6 to 60-month follow-up, reported live-birth rate was 50% (0.37-0.63 95% CI) from a clinical pregnancy rate of 73% (0.51-0.91 95% CI) and miscarriage rate was 23% (0.15-0.30 95% CI). Hysteroscopic metroplasty for dysmorphic uteri led half of the women who experienced recurrent miscarriages at least one live birth and is correlated to few surgical and obstetric complications. However, randomized clinical trials and case-control studies are unavailable due to ethical constrains; inhomogenity of follow-up durations and standardized protocols regarding preoperative diagnosis and post-surgical management resrict our conclusions.
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http://dx.doi.org/10.1016/j.jogoh.2020.101763DOI Listing
September 2020

Ion Channels in The Pathogenesis of Endometriosis: A Cutting-Edge Point of View.

Int J Mol Sci 2020 Feb 7;21(3). Epub 2020 Feb 7.

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.

Background: Ion channels play a crucial role in many physiological processes. Several subtypes are expressed in the endometrium. Endometriosis is strictly correlated to estrogens and it is evident that expression and functionality of different ion channels are estrogen-dependent, fluctuating between the menstrual phases. However, their relationship with endometriosis is still unclear.

Objective: To summarize the available literature data about the role of ion channels in the etiopathogenesis of endometriosis.

Methods: A search on PubMed and Medline databases was performed from inception to November 2019.

Results: Cystic fibrosis transmembrane conductance regulator (CFTR), transient receptor potentials (TRPs), aquaporins (AQPs), and chloride channel (ClC)-3 expression and activity were analyzed. CFTR expression changed during the menstrual phases and was enhanced in endometriosis samples; its overexpression promoted endometrial cell proliferation, migration, and invasion throughout nuclear factor kappa-light-chain-enhancer of activated B cells-urokinase plasminogen activator receptor (NFκB-uPAR) signaling pathway. No connection between TRPs and the pathogenesis of endometriosis was found. AQP5 activity was estrogen-increased and, through phosphatidylinositol-3-kinase and protein kinase B (PI3K/AKT), helped in vivo implantation of ectopic endometrium. In vitro, AQP9 participated in extracellular signal-regulated kinases/p38 mitogen-activated protein kinase (ERK/p38 MAPK) pathway and helped migration and invasion stimulating matrix metalloproteinase (MMP)2 and MMP9. ClC-3 was also overexpressed in ectopic endometrium and upregulated MMP9.

Conclusion: Available evidence suggests a pivotal role of CFTR, AQPs, and ClC-3 in endometriosis etiopathogenesis. However, data obtained are not sufficient to establish a direct role of ion channels in the etiology of the disease. Further studies are needed to clarify this relationship.
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http://dx.doi.org/10.3390/ijms21031114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7037987PMC
February 2020

Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence.

Dis Colon Rectum 2020 04;63(4):514-519

Department of Medical, Surgical, Neurologic, Metabolic and Aging Sciences, General, Mini-invasive and Obesity Surgery Unit, University of Campania "Luigi Vanvitelli," Naples, Italy.

Background: Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown.

Objective: The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper.

Design: This was a prospective clinical study.

Settings: The study was conducted at a large university tertiary care hospital.

Patients: Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures.

Interventions: All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation.

Main Outcome Measures: The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively.

Results: Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term.

Limitations: The study was limited by its small sample size and absence of quality-of-life data.

Conclusions: Initial improvements after Gatekeeper implantation for fecal incontinence are sustained in the middle term. Accurate preoperative evaluation of coexistent clinical conditions that may negatively affect outcomes is recommended for patient selection. See Video Abstract at http://links.lww.com/DCR/B109. RESULTADOS A MEDIANO PLAZO EN LA IMPLANTACIÓN DE GATEKEEPER PARA LA INCONTINENCIA FECAL: Los agentes de volumen inyectables interesfintéricos, son opciones actuales de tratamiento para la incontinencia fecal, ante fallas de terapias conductuales y médicas. Gatekeeper mostró resultados prometedores a corto plazo, pero resultados a largo plazo aún son desconocidos.Evaluar clínicamente una cohorte prospectiva de pacientes con incontinencia fecal, hasta 36 meses después de la implantación de Gatekeeper.Estudio clínico prospectivo.El estudio se realizó en un gran hospital universitario de atención terciaria.Fueron elegibles pacientes femeninas consecutivas, si el inicio de la incontinencia fecal, fue al menos 6 meses antes de la primera visita, y que los síntomas fueron refractarios a las medidas conservadoras estandarizadas.Todas las pacientes fueron sometidas a implantación de 4 o 6 prótesis Gatekeeper. Se realizó ecografía endoanal de 3D y manometría anorrectal de alta resolución, antes de la implantación y después a los 2 y 3 meses.Se calculó el puntaje de incontinencia fecal de la Cleveland Clinic al inicio, y a los 1, 3, 12, 24 y 36 meses después de la operación.Se inscribieron veinte pacientes (todas mujeres; con edad media de 59 años), y todos los implantes transcurrieron sin incidentes. La ecografía endoanal postoperatoria, mostró localización normal de la prótesis en 16 (80%) pacientes. A la manometría, la presión media de reposo anal, mejoró significativamente (57.8 ± 7.5 mmHg, p = 0.0004). La puntuación media preoperatoria de la incontinencia fecal de la Cleveland Clinic, fue de 12.35 ± 1.75, con mejoras significativas documentadas inicialmente a los 3 meses (4.9 ± 1.5, p <0.0001) y sostenidas hasta los 36 meses (4.9 ± 1.7, p <0.0001). Los pacientes que recibieron solo 4 prótesis (en comparación con 6) y que padecían neuropatía pudenda (en comparación con aquellas que no la padecían), mostraron valores de puntaje de Incontinencia Fecal de la Clínica Cleveland, significativamente más altos en el mediano plazo.El tamaño pequeño de la muestra y la ausencia de datos en calidad de vida.Las mejoras iniciales después de la implantación de Gatekeeper para la incontinencia fecal, se mantienen en el mediano plazo. Para la selección de pacientes, se recomienda una precisa evaluación preoperatoria de las condiciones clínicas coexistentes, que puedan afectar negativamente los resultados. Consulte Video Resumen en http://links.lww.com/DCR/B109.
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http://dx.doi.org/10.1097/DCR.0000000000001559DOI Listing
April 2020
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