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OBJECTIVE: To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf) in the management of moderate to severe intrauterine adhesions (IUA). DESIGN: PREG-2 study was a multicenter, double-blind, randomized, controlled, stratified, two-arm superiority clinical trial conducted in 16 centers in seven countries. SETTING: Not applicable. PATIENT(S): Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American Fertility Society [AFS] IUA score) were considered eligible for the study. INTERVENTION(S): After adhesiolysis, patients were randomized at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group). MAIN OUTCOME MEASURE(S): The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, and compared with baseline. Information on the rate of no IUA and responder rate was collected as secondary effectiveness outcomes, while reported adverse events and patient-reported outcomes as safety and tolerability measures. RESULT(S): Between October 26, 2021, and September 28, 2023, a total of 160 women were randomized (Womed Leaf: n = 75 and controls: n = 85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared with the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs. 24%; odds ratio, 2.44; confidence interval, 1.161-5.116). None of the reported adverse events were serious or considered related to the device. CONCLUSION(S): Womed Leaf is effective and safe in the management of symptomatic severe or moderate IUAs. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT04963179.
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OBJECTIVE: To update the 2010 CNGOF clinical practice guidelines for the first-line management of infertile couples. MATERIALS AND METHODS: Five major themes (first-line assessment of the infertile woman, first-line assessment of the infertile man, prevention of exposure to environmental factors, initial management using ovulation induction regimens, first-line reproductive surgery) were identified, enabling 28 questions to be formulated using the Patients, Intervention, Comparison, Outcome (PICO) format. Each question was addressed by a working group that had carried out a systematic review of the literature since 2010, and followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) methodology to assess the quality of the scientific data on which the recommendations were based. These recommendations were then validated during a national review by 40 national experts. RESULTS: The fertility work-up is recommended to be prescribed according to the woman's age: after one year of infertility before the age of 35 and after 6months after the age of 35. A couple's initial infertility work-up includes a single 3D ultrasound scan with antral follicle count, assessment of tubal permeability by hysterography or HyFOSy, anti-Mullerian hormone assay prior to assisted reproduction, and vaginal swabbing for vaginosis. If the 3D ultrasound is normal, hysterosonography and diagnostic hysteroscopy are not recommended as first-line procedures. Chlamydia trachomatis serology does not have the necessary performance to predict tubal patency. Post-coital testing is no longer recommended. In men, spermogram, spermocytogram and spermoculture are recommended as first-line tests. If the spermogram is normal, it is not recommended to check the spermogram. If the spermogram is abnormal, an examination by an andrologist, an ultrasound scan of the testicles and hormonal test are recommended. Based on the data in the literature, we are unable to recommend a BMI threshold for women that would contraindicate medical management of infertility. A well-balanced Mediterranean-style diet, physical activity and the cessation of smoking and cannabis are recommended for infertile couples. For fertility concern, it is recommended to limit alcohol consumption to less than 5 glasses a week. If the infertility work-up reveals no abnormalities, ovulation induction is not recommended for normo-ovulatory women. If intrauterine insemination is indicated based on an abnormal infertility work-up, gonadotropin stimulation and ovulation monitoring are recommended to avoid multiple pregnancies. If the infertility work-up reveals no abnormality, laparoscopy is probably recommended before the age of 30 to increase natural pregnancy rates. In the case of hydrosalpinx, surgical management is recommended prior to ART, with either salpingotomy or salpingectomy depending on the tubal score. It is recommended to operate on polyps>10mm, myomas 0, 1, 2 and synechiae prior to ART. The data in the literature do not allow us to systematically recommend asymptomatic uterine septa and isthmoceles as first-line surgery. CONCLUSION: Based on strong agreement between experts, we have been able to formulate updated recommendations in 28 areas concerning the initial management of infertile couples.
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Infertilidade Feminina , Infertilidade Masculina , Humanos , Feminino , Infertilidade Feminina/terapia , Masculino , França , Infertilidade Masculina/terapia , Infertilidade Masculina/etiologia , Ginecologia/métodos , Obstetrícia/métodos , Indução da Ovulação/métodos , Técnicas de Reprodução Assistida , Adulto , Sociedades Médicas , Gravidez , Obstetra , GinecologistaRESUMO
OBJECTIVE: Unrecognized ureteral and bladder injury increase morbidity and mortality in gynecologic surgery. The primary objective of this study is to analyze the efficiency of a systematic intra-venous (IV) injection of carmine indigo to detect bladder injury in gynecologic vaginal surgery for benign disease. The secondary objective is to analyze the cost and use of carmine indigo. STUDY DESIGN: A retrospective, monocentric study was conducted in a tertiary hospital between January 2018 and October 2021. All patients undergoing a vaginal surgery of hysterectomy for benign disease or anterior prolapse were systematically included. Patients can be systematically included by the automatic coding of surgery. After anesthesia, during the patient's installation, an intravenous injection of 5 mL of intravenous indigo carmine (Carmyne®) diluted in 100 mL of physiological serum was systematically administered by the anesthesia team. Intraoperative cystoscopy was performed only in cases of suspected associated ureteral injury. RESULTS: We recorded 443 vaginal hysterectomies for benign disease and 95 vaginal anterior prolapse surgeries. There were 6 (1,4%) bladder injuries during vaginal hysterectomies and 1 (1,1%) bladder injury during vaginal prolapse surgery. All bladder injuries were diagnosed intraoperatively. No ureteral injury was diagnosed in this series of patients. No complication related to IV indigo carmine injection was found. In this tertiary hospital, 1085 ampoules of carmine indigo were ordered during the same period, approximatively 270 per year. The total cost to the gynecology and obstetrics department was 19,600 euros, or about 4,900 euros per year. Half of the carmine indigo was used in vaginal surgery and half in laparotomy, caesarean section and endometriosis surgery for suspected bladder or ureteral injury.
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Doenças Urológicas , Prolapso Uterino , Humanos , Gravidez , Feminino , Índigo Carmim/efeitos adversos , Carmim , Corantes/efeitos adversos , Estudos Retrospectivos , Cesárea , Doenças Urológicas/diagnóstico , Prolapso Uterino/cirurgiaRESUMO
The French National College of Obstetricians and Gynecologists (CNGOF) published guidelines for managing endometriosis-associated pain in 2018. Given the development of new pharmacological therapies and a review that was published in 2021, most national and international guidelines now suggest a new therapeutic approach. In addition, a novel validated screening method based on patient questionnaires and analysis of 109-miRNA saliva signatures, which combines biomarkers and artificial intelligence, opens up new avenues for overcoming diagnostic challenges in patients with pelvic pain and for avoiding laparoscopic surgery when sonography and MRI are not conclusive. Dienogest (DNG) 2 mg has been a reimbursable healthcare expense in France since 2020, and, according to recent studies, it is at least as effective as combined hormonal contraception (CHC) and can be used as an alternative to CHC for first-line treatment of endometriosis-associated pain. Since 2018, the literature concerning the use of DNG has grown considerably, and the French guidelines should be modified accordingly. The levonorgestrel intrauterine system (LNG IUS) and other available progestins per os, including DNG, or the subcutaneous implant, can be offered as first-line therapy, gonadotropin-releasing hormone (GnRH) agonists with add-back therapy (ABT) as second-line therapy. Oral GnRH antagonists are promising new medical treatments for women with endometriosis-associated pain. They competitively bind to GnRH receptors in the anterior pituitary, preventing native GnRH from binding to GnRH receptors and from stimulating the secretion of luteinizing hormone and follicle-stimulating hormone. Consequently, estradiol and progesterone production is reduced. Oral GnRH antagonists will soon be on the market in France. Given their mode of action, their efficacy is comparable to that of GnRH agonists, with the advantage of oral administration and rapid action with no flare-up effect. Combination therapy with ABT is likely to allow long-term treatment with minimal impact on bone mass. GnRH antagonists with ABT may thus be offered as second-line treatment as an alternative to GnRH agonists with ABT. This article presents an update on the management of endometriosis-associated pain in women who do not have an immediate desire for pregnancy.
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Endometriose , Feminino , Humanos , Endometriose/complicações , Endometriose/diagnóstico , Endometriose/tratamento farmacológico , Receptores LHRH , Inteligência Artificial , Dor Pélvica/tratamento farmacológico , Dor Pélvica/etiologia , Hormônio Liberador de Gonadotropina/uso terapêutico , Antagonistas de Hormônios/uso terapêuticoRESUMO
INTRODUCTION: Lifetime risk of surgery for female pelvic organ prolapse (FPOP) is estimated at 10 to 20%. Prolapse assessment is mostly done by clinical examination. Perineal ultrasound is easily available and performed to evaluate and stage FPOP. This study's aim is to evaluate the agreement between clinical examination by POP-Q and perineal sonography in women presenting pelvic organ prolapse. MATERIALS AND METHODS: We carried out a prospective study from December 2015 to March 2018 in the gynecologic department of a teaching hospital. Consecutive woman requiring a surgery for pelvic organ prolapse were included. All women underwent clinical examination by POP-Q, perineal ultrasound with measurements of each compartment descent, levator hiatus area and posterior perineal angle. They also answered several functional questionnaires (PFDI 20, PFIQ7, EQ-5D and PISQ12) before and after surgery. Data for clinical and sonographic assessments were compared with Spearman's test and correlation with functional questionnaires was tested. RESULTS: 82 women were included. We found no significant agreement between POP-Q and sonographic measures of bladder prolapse, surface of the perineal hiatus or perineal posterior angle. There was a significant improvement of most of the functional scores after surgery. DISCUSSION: Our study does not suggest correlation between clinical POP-Q and sonographic assessment of bladder prolapse, hiatus surface or perineal posterior angle. Ultrasound datasets were limited by an important number of missing data resulting in a lack of power.
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Prolapso de Órgão Pélvico , Feminino , Humanos , Estudos Prospectivos , Prolapso de Órgão Pélvico/diagnóstico por imagem , Prolapso de Órgão Pélvico/cirurgia , Exame Físico , Ultrassonografia/métodos , Períneo/diagnóstico por imagemRESUMO
OBJECTIVE: To evaluate safety of prenatal corticosteroids in pregnancies of women with sickle cell disease. METHODS: A multicenter observational study of patients with sickle cell disease, comparing vaso-occlusive crises (VOC) requiring hospital care between pregnancies with versus without prenatal corticosteroids. RESULTS: In 40 pregnancies exposed to prenatal corticosteroids, compared with 370 unexposed pregnancies, VOC were not more frequent (62.5% vs 57.9%, P = 0.578) but they were more severe, with more intensive care hospitalizations (25.0% vs 12.9%, P = 0.039), emergency transfusions (44.7% vs 22.7%, P = 0.006), and acute chest syndromes (22.5% vs 8.9%, P = 0.010). These differences persisted after adjustment for severity and type of sickle cell syndrome (for intensive care admission adjusted odds ratio [aOR] 2.73, 95% confidence interval [CI] 1.10-6.79, P = 0.031 and for acute chest syndrome aOR 4.15, 95% CI 1.57-14.4, P = 0.008). VOC occurred on average 1.2 days following steroid administration. When comparing 36 patients receiving corticosteroids for fetal maturation with 58 patients who were hospitalized for obstetrical complications before 34 weeks of pregnancy but that did not receive corticosteroids, VOC incidence was not significantly higher (41.7% vs 31.5%, P = 0.323). CONCLUSION: The present study was the first to study the impact of prenatal corticosteroids on sickle cell disease. They were associated with more severe VOC, suggesting that steroids should be avoided in these women.
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Anemia Falciforme , Compostos Orgânicos Voláteis , Humanos , Feminino , Gravidez , Gestantes , Anemia Falciforme/complicações , Anemia Falciforme/tratamento farmacológico , Corticosteroides/efeitos adversos , HospitalizaçãoRESUMO
OBJECTIVES: To estimate diagnostic accuracy of sonography in the diagnosis of adenomyosis in current practice when compared to pathology as a "gold standard". METHODS: This diagnosis accuracy study was observational and retrospective, including women managed by hysterectomy for benign pathology from January 2015 to November 2018. Preoperative pelvic sonography reports were collected, including details on diagnosis criteria for adenomyosis. Sonographic findings were compared to pathological results of the hysterectomy specimens. RESULTS: Our study initially concerned 510 women; 242 of them had adenomyosis confirmed by a pathological examination. The pathological prevalence of adenomyosis was 47.4% in this study. A preoperative sonography was available for 89.4% of the 242 women, with a suspicion of adenomyosis in 32.7% of them. In this study, Sensitivity is 52%, Specificity 85%, Positive Predictive Value (PPV) 77%, Negative Predictive Value (NPV) 86% and Accuracy 38,1%. CONCLUSIONS: Pelvic sonography is the most common non-invasive examination used in gynecology. It is also the first recommended examination for the diagnosis of adenomyosis because of its acceptability and its cost, even if the diagnosis performances are moderate. However, these performances are comparable to MRI (Magnetic Resonance Imaging) performances. The use of a standardized sonographic classification could improve and harmonize the diagnosis of adenomyosis.
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Adenomiose , Feminino , Humanos , Adenomiose/patologia , Estudos Retrospectivos , Sensibilidade e Especificidade , Ultrassonografia , HisterectomiaRESUMO
Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.
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Aborto Espontâneo , Gravidez Ectópica , Gravidez , Humanos , Feminino , Adulto , Curetagem a Vácuo , Método Simples-Cego , HisteroscopiaRESUMO
Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.
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STUDY OBJECTIVE: To study the severity of intrauterine adhesions (IUA) after uterine arterial embolization and to evaluate fertility, pregnancy, and obstetrical outcomes after hysteroscopic treatment. DESIGN: Retrospective cohort. SETTING: French University Hospital. PATIENTS: Thirty-three patients under the age of 40 years who were treated by uterine artery embolization with nonabsorbable microparticles between 2010 and 2020 for symptomatic fibroids or adenomyosis, or postpartum hemorrhage. INTERVENTIONS: All patients had a diagnosis of IUA after embolization. All patients desired future fertility. IUA was treated with operative hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Severity of IUA, number of operative hysteroscopies performed to obtain a normal cavity shape, pregnancy rate, and obstetrical outcomes. Of our 33 patients, 81.8% had severe IUA (state IV et V according to the European Society of Gynecological Endoscopy or state III according to the American fertility society classification). To restore fertility potential, an average of 3.4 operative hysteroscopies had to be performed [CI 95% (2.56-4.16)]. We reported a very low rate of pregnancy (8/33, 24%). Obstetrical outcomes reported are 50% of premature birth and 62.5% of delivery hemorrhage partly due to 37.5% of placenta accreta. We also reported 2 neonatal deaths. CONCLUSION: IUA after uterine embolization is severe, and more difficult to treat than other synechiae, probably related to endometrial necrosis. Pregnancy and obstetrical outcomes have shown a low pregnancy rate, an increased risk of preterm delivery, a high risk of placental disorders, and very severe postpartum hemorrhage. Those results have to alert gynecologists and radiologists to the use of uterine arterial embolization in women who desire future fertility.
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Ginatresia , Hemorragia Pós-Parto , Nascimento Prematuro , Embolização da Artéria Uterina , Doenças Uterinas , Recém-Nascido , Feminino , Humanos , Gravidez , Adulto , Estudos de Coortes , Embolização da Artéria Uterina/efeitos adversos , Estudos Retrospectivos , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Ginatresia/etiologia , Ginatresia/cirurgia , Placenta , Doenças Uterinas/cirurgia , Doenças Uterinas/complicações , Histeroscopia/efeitos adversos , FertilidadeRESUMO
BACKGROUND: The occurrence of acute liver failure (ALF) in pregnant women due to an etiology unrelated to pregnancy (pregALF) that leads to liver transplantation (LT) has rarely been reported. The objective was to report the outcome of pregnant women and fetus and propose a strategy for the timing of delivery and of LT in these patients. METHODS: Five consecutive pregnant patients with ALF were admitted to our center between 1986 and 2018 and underwent an LT. A systematic review of case reports concerning patients with pregALF who underwent LT was extracted from the literature. RESULTS: Three with gestational ages (GA) at admission of 15, 22, and 31 weeks of gestation (WG) were transplanted after delivery (n = 1) or intrauterine demise (n = 2) and 2 with GA of 16 and 23 WG before delivery. One infant survived in each group. Among the 32 cases published previously, 11 (34%) had been transplanted after delivery (median GA:31 [28-33]); 10 of these 11 infants were alive at birth. The other 21 mothers were transplanted before delivery (GA:21 WG [18-22]). The median GA at delivery was 30 WG [27.75-37]. Twelve of 21 infants were alive at birth. One-year survival among the ALF patients in our series and in the literature was 100%. Overall, the perinatal survival rate was low (64.8%). CONCLUSIONS: In pregnant patients presenting with ALF not related to the pregnancy, the LT lifesaving procedure had an excellent outcome. Overall, 65% of the infants were alive at delivery with major mortality in those fetus <22 WG despite continued pregnancy.
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Falência Hepática Aguda , Transplante de Fígado , Lactente , Recém-Nascido , Humanos , Feminino , Gravidez , Transplante de Fígado/métodos , Falência Hepática Aguda/diagnóstico , Falência Hepática Aguda/cirurgia , Taxa de Sobrevida , Idade GestacionalRESUMO
BACKGROUND: Ovarian drilling is a surgical technique for patients with dysovulatory polycystic ovarian syndrome. It is proposed as a second-line treatment in case of failure of medical treatment with Clomiphene citrate, Metformin or Letrozole. The 2020 Cochrane study comparing gonadotrophin stimulation and drilling has found the same pregnancy rate in both cases. The literature review concludes that 50% of spontaneous ovulation occurs in the first three months after drilling and 80% of pregnancy occurs in the following year. Ovarian drilling has also an impact on androgen excess and metabolic syndrome. AIMS: To update on the different surgical techniques to perform an ovarian drilling: surgical approach, energy used, operative risks. TECHNIQUES: The objective of an ovarian drilling is to destroy 5% of the ovarian stroma. It is recommended to perform 8 to 10 perforations in each ovary with bipolar energy. Laser C02 and monopolar energy can be used but increase the risk of adhesion. The surgical approach is actually laparoscopic. Abdominal laparoscopy or transvaginal laparoscopy by vNOTES can be performed. The advantage of the second one is to provide an easier access to the pelvic cavity in case of obesity and patient have no abdominal scare. Both laparoscopic approaches allow an evaluation of tubal patency and adhesiolysis or fimbrioplasty. That it's not the case of an alternative technique: the fertiloscopy, due to coaxial instrumentation in spite of less rate of post-operative adhesions. Operative risks are abdominal adhesions, damage to neighboring organs and due to the general anesthesia. CONCLUSION: Different surgical techniques exist to perform an ovarian drilling. The surgeon can choose the one that he masters best and that will involve the least risk for the patient. It is recommended to use bipolar energy.
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Infertilidade Feminina , Laparoscopia , Síndrome do Ovário Policístico , Feminino , Humanos , Gravidez , Clomifeno/uso terapêutico , Infertilidade Feminina/etiologia , Infertilidade Feminina/cirurgia , Ovulação , Síndrome do Ovário Policístico/complicações , Síndrome do Ovário Policístico/cirurgia , Laparoscopia/métodosRESUMO
BACKGROUND: The discovery of a saliva-based microribonucleic acid (miRNA) signature for endometriosis in 2022 opened up new perspectives for early and noninvasive diagnosis of the disease. The 109-miRNA saliva signature is the product of miRNA biomarkers and artificial intelligence (AI) modeling. We designed a multicenter study to provide external validation of its diagnostic accuracy. We present here an interim analysis. METHODS: The first 200 patients included in the multicenter prospective ENDOmiRNA Saliva Test study (NCT05244668) were included for interim analysis. The study population comprised women from 18 to 43 years of age with a formal diagnosis of endometriosis or with suspected endometriosis. Epidemiologic, clinical, and saliva sequencing data were collected between November 2021 and March 2022. Genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing (NGS) was performed, and a random forest algorithm was used to assess the diagnostic accuracy. RESULTS: In this interim analysis of the external validation cohort, with a population prevalence of 79.5%, the 109-miRNA saliva diagnostic signature for endometriosis had a sensitivity of 96.2% (95% confidence interval [CI], 93.7 to 97.3%), specificity of 95.1% (95% CI, 85.2 to 99.1%), positive predictive value of 95.1% (95% CI, 85.2 to 99.1%), negative predictive value of 86.7% (95% CI, 77.6 to 90.3%), positive likelihood ratio of 19.7 (95% CI, 6.3 to 108.8), negative likelihood ratio of 0.04 (95% CI, 0.03 to 0.07), and area under the receiver operating characteristic curve of 0.96 (95% CI, 0.92 to 0.98). CONCLUSIONS: The use of NGS and AI in the sequencing and analysis of miRNA provided a saliva-based miRNA signature for endometriosis. Our interim analysis of a prospective multicenter external validation study provides support for its ongoing investigation as a diagnostic tool. (Funded by Ziwig and the Conseil Régional d'Ile de France [Grant EX024087]; ClinicalTrials.gov number, NCT05244668.)
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Endometriose , MicroRNAs , Feminino , Humanos , MicroRNAs/genética , Endometriose/diagnóstico , Estudos Prospectivos , Reprodutibilidade dos Testes , Biomarcadores Tumorais/genéticaRESUMO
STUDY OBJECTIVE: To evaluate the epidemiologic and economic burden related to adhesions and their complications for the French healthcare system. DESIGN: A descriptive and economic retrospective analysis. SETTING: Medicalized information system program (PMSI), national scale of costs. PATIENTS: Female patients operated on to treat adhesions related complications in 2019. INTERVENTIONS: All patients with coded adhesiolysis acts were selected in order to identify the characteristics of Diagnosis related groups (DRG) and compare them with the general DRGs. Then, a sub-analysis on surgery types (laparoscopy or open procedures) was performed to evaluate impact adhesions development and Length of Stay. Lastly, direct costs of adhesions for the healthcare system were quantified based upon adhesiolysis acts coded as main diagnosis. MEASUREMENTS AND MAIN RESULTS: 26.387 adhesiolysis procedures were listed in France in 2019 through 8 adhesiolysis acts regrouping open surgeries and laparoscopic procedures. Adhesiolysis was coded in up to 34% in some DRGs for laparoscopic procedures. 1551 (1461 studied in our study) surgeries have been realized in 2019 with main procedure: adhesiolysis. These surgeries were associated with an expense of 4 million for the healthcare system for rehospitalizations and reoperations only. Social costs such as sick leaves, drugs and other cares haven't been taken in consideration. CONCLUSION: Adhesions related complications represent a massive burden for patients and an expensive problem for society. These difficulties may likely to be reduced by a broader use of antiadhesion barriers, at least in some targeted procedures.
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Laparoscopia , Humanos , Feminino , Estudos Retrospectivos , Aderências Teciduais/etiologia , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Pelve , Reoperação/efeitos adversos , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Primary Ovarian Insufficiency (POI), a public health problem, affects 1-3.7% of women under 40 yielding infertility and a shorter lifespan. Most causes are unknown. Recently, genetic causes were identified, mostly in single families. We studied an unprecedented large cohort of POI to unravel its molecular pathophysiology. METHODS: 375 patients with 70 families were studied using targeted (88 genes) or whole exome sequencing with pathogenic/likely-pathogenic variant selection. Mitomycin-induced chromosome breakages were studied in patients' lymphocytes if necessary. FINDINGS: A high-yield of 29.3% supports a clinical genetic diagnosis of POI. In addition, we found strong evidence of pathogenicity for nine genes not previously related to a Mendelian phenotype or POI: ELAVL2, NLRP11, CENPE, SPATA33, CCDC150, CCDC185, including DNA repair genes: C17orf53(HROB), HELQ, SWI5 yielding high chromosomal fragility. We confirmed the causal role of BRCA2, FANCM, BNC1, ERCC6, MSH4, BMPR1A, BMPR1B, BMPR2, ESR2, CAV1, SPIDR, RCBTB1 and ATG7 previously reported in isolated patients/families. In 8.5% of cases, POI is the only symptom of a multi-organ genetic disease. New pathways were identified: NF-kB, post-translational regulation, and mitophagy (mitochondrial autophagy), providing future therapeutic targets. Three new genes have been shown to affect the age of natural menopause supporting a genetic link. INTERPRETATION: We have developed high-performance genetic diagnostic of POI, dissecting the molecular pathogenesis of POI and enabling personalized medicine to i) prevent/cure comorbidities for tumour/cancer susceptibility genes that could affect life-expectancy (37.4% of cases), or for genetically-revealed syndromic POI (8.5% of cases), ii) predict residual ovarian reserve (60.5% of cases). Genetic diagnosis could help to identify patients who may benefit from the promising in vitro activation-IVA technique in the near future, greatly improving its success in treating infertility. FUNDING: Université Paris Saclay, Agence Nationale de Biomédecine.
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Infertilidade , Insuficiência Ovariana Primária , Feminino , Humanos , Infertilidade/complicações , Mitomicinas , NF-kappa B , Medicina de Precisão , Insuficiência Ovariana Primária/etiologiaRESUMO
Loss of consciousness suddenly occurred in 2 healthy and nonsmoking patients undergoing bipolar resection for intramural myomas under spinal anesthesia. One patient had nystagmus and emesis. In both cases, neurological symptoms were of short duration. All other usual causes were excluded. Initial venous carboxyhemoglobin concentrations were 7% and 23%, respectively. These concentrations decreased within several hours with oxygen therapy. Carbon monoxide (CO) is a product of diathermic vaporization and may enter the blood and cause intraoperative cardiovascular symptoms. These are the first cases with neurological presentation. The CO poisoning was probably diagnosed early because the patients were awake.
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Raquianestesia , Intoxicação por Monóxido de Carbono , Raquianestesia/efeitos adversos , Intoxicação por Monóxido de Carbono/diagnóstico , Intoxicação por Monóxido de Carbono/terapia , Carboxihemoglobina , Feminino , Humanos , Histeroscopia/efeitos adversos , Oxigenoterapia , GravidezRESUMO
INTRODUCTION: Pelvic organ prolapse is a very frequent affection especially in elderly women. Vaginal pessary is a common conservative treatment and recommended as first line therapy. Guidelines recommend to do a regular follow up every 6 to 12 months with a healthcare professional. We report the case of a patient with neglected vaginal pessary who had a vesicovaginal and a concomitant rectovaginal fistula. CASE REPORT: A 84-year-old woman was admitted for chronic pelvic pain and vaginal discharge. An entrapped cube pessary was removed and the diagnostic of a 3cm rectovaginal fistula with a vesicovaginal fistula was made. The patient had a two-stage surgery, vaginal way then open abdominal way, for closing the fistulas. CONCLUSION: Although vaginal pessary is a good conservative treatment for POP, it shall not be neglected or serious complications can be caused.
Assuntos
Prolapso de Órgão Pélvico , Fístula Vesicovaginal , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Pessários/efeitos adversos , Fístula Retovaginal/terapia , Fístula Retovaginal/complicações , Fístula Vesicovaginal/etiologia , Fístula Vesicovaginal/terapia , Fístula Vesicovaginal/diagnóstico , Prolapso de Órgão Pélvico/terapia , Prolapso de Órgão Pélvico/cirurgia , VaginaRESUMO
OBJECTIVE: Hospital-day-care surgery is currently a priority for the healthcare system and is booming due to its' favorable financial impact. In gynecology, the management of surgical interventions for patients who've come to the Hospital Emergency Department, could in a number of cases, be delayed for a few h or several days. It would be it possible to organize a specific hospital day-care management program for the delayed surgeries. The aim of the study is to evaluate the feasibility of hospital day-care management of delayed gynecological emergencies. METHODS: This is a prospective, observational, unicentric study performed in the gynecological department of a teaching hospital from January 2016 through March 2017. Women having gynecological emergencies requiring surgical management were included in this study. The leading causes for surgical management and thus for inclusion in this study were nonviable pregnancies or retained products of conception, vulvar or breast abscesses, ectopic pregnancies and complications of ovarian cysts. For women with emergencies that could be delayed, surgery was scheduled between 12 h and 12 days after a woman's initial emergency examination at the hospital. Postoperative consultation was at the emergency department or completed by the referring physician. Re-hospitalization and re-intervention rates were collected 6 to 8 weeks after the initial emergency management. RESULTS: Three hundred and forty-eight women requiring surgical management consulted for gynecological emergencies over the period of the study. One hundred and eighty-one (52%) were managed in delayed day-care. The rate of surgical emergency management between the initial emergency consultation and the delayed day-care surgery was 1.8%. The consultation rate of a return to the emergency department prior to the planned delayed day-care was 12.2% (21/171). The rate of unplanned re-admissions in the month following surgery was 1.8% (3/171). The overall Satisfaction rate was high (170/171 99.4%). CONCLUSION: The delayed surgical management of gynecological emergencies thus seems feasible and beneficial for both women and the healthcare system. An economic evaluation could be performed to evaluate the lower costs/savings for delayed day-care management of gynecological emergencies.
Assuntos
Emergências , Procedimentos Cirúrgicos em Ginecologia , Procedimentos Cirúrgicos Ambulatórios , Estudos de Viabilidade , Feminino , Hospitalização , Humanos , GravidezRESUMO
STUDY OBJECTIVE: To show a new mini-invasive surgical technique of ovarian drilling and fertility workup using transvaginal natural orifice transluminal endoscopic surgery (vNOTES). DESIGN: Stepwise demonstration of the technique with narrated video footage. SETTING: Ovarian drilling is a surgical technique for patients with dysovulatory polycystic ovary syndrome. The aim of this technique is to destroy 5% to 10% of the ovarian cortex to restore spontaneous ovulation. Drilling is proposed as a second-line treatment in case of failure of treatments with clomid, metformin, or letrozole. The Cochrane 2020 review shows that drilling has the same pregnancy rate as the other second-line treatment: stimulation with gonadotropins [1]. After ovarian drilling, the results show 80% of spontaneous ovulation within 3 months and 50% of spontaneous pregnancy within a year; these results are effective in the long term [2]. The techniques used until now were either classic laparoscopy or transvaginal hydrolaparoscopy, which is currently not feasible owing to the cessation of the kit [3,4]. We present to you a new surgical technique: ovarian drilling by vNOTES. This new technique is minimally invasive, without scarring on the abdomen, and very well tolerated. It allows simultaneous ovarian drilling and fertility workup with assessment of tubal patency and uterine cavity by hysteroscopy. It is recommended to use bipolar energy to reduce ovarian lesions and limit the risk of adhesion [5]. INTERVENTIONS: Transvaginal laparoscopic ovarian drilling is a minimally invasive surgical technique using a vNOTES kit from Applied Medical (Rancho Santa Margarita, CA), a hysteroscope of 5 mm with an operating channel from Delmont Imaging (La Ciotat, France), and a bipolar spring electrode, Versapoint from Olympus (Hamburg, Germany). The key steps to perform this surgery are as follows: 1. Perform a diagnostic hysteroscopy with vaginoscopy 2. Perform a posterior colpotomy 3. Introduce the Alexis retractor into the Douglas and place the GelPOINT with 2 sleeves 4. Introduce the hysteroscope into the pelvic cavity with serum saline, using a pressure of approximately 150 mm Hg 5. Drill approximately 10 holes on each ovary using the bipolar electrode 6. Explore the pelvic cavity with the possibility of performing a blue test for tubal patency 7. Suture the posterior vagina CONCLUSION: Ovarian drilling is a surgical treatment proposed after the failure of first-line treatments in polycystic ovary syndrome to obtain long-term spontaneous ovulations. The development of minimally invasive techniques such as vNOTES will highlight this treatment and allow it to be performed easily and with minimal adverse effects on patients, especially in bariatric women for whom the vNOTES technique provides easier access to their pelvic cavity than abdominal laparoscopy.