Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynaecologists and Obstetricians (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding (i.e. pharmaceutical or medical device companies). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège National des Gynécologues et Obstétriciens Français on the management of women with AUB were published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescents; idiopathic AUB; endometrial hyperplasia and polyps; type 0-2 fibroids; type 3 or higher fibroids; and adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and evidence profiles were compiled. The GRADE® methodology was applied to the literature review and the formulation of recommendations. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 are strong and 17 weak. No response was found in the literature for 14 questions. We chose to abstain from recommendations rather than providing advice based solely on expert clinical experience. CONCLUSIONS: The 36 recommendations make it possible to specify the diagnostic and therapeutic strategies for various clinical situations practitioners encounter, from the simplest to the most complex.

Management of postmenopausal women: Collège National des Gynécologues et Obstétriciens Français (CNGOF) and Groupe d'Etude sur la Ménopause et le Vieillissement (GEMVi) Clinical Practice Guidelines.

AIM: The aim of these recommendations is to set forth an individualized approach to the management of early postmenopausal women (i.e., within the first 10 years after natural menopause) covering all aspects of lifestyle and therapeutic management, with or without menopause hormone therapy (MHT). MATERIALS AND METHODS: Literature review and consensus of French expert opinion. Recommendations were graded according to the HAS methodology and levels of evidence derived from the international literature, except when there was no good-quality evidence. SUMMARY RECOMMENDATIONS: The beginning of menopause is an ideal time for each woman to evaluate her health status by assessing her bone, cardiovascular, and cancer-related risk factors that may be amplified by postmenopausal estrogen deficiency and by reviewing her lifestyle habits. Improving lifestyle, including nutrition and physical activity, and avoiding risk factors (notably smoking), should be recommended to all women. MHT remains the most effective treatment for vasomotor symptoms but it could be also recommended as first-line treatment for the prevention of osteoporosis in early postmenopausal women at low to moderate risk for fracture. The risks of MHT differ depending on its type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. There is reasonable evidence that using transdermal estradiol in association with micronized progesterone or dydrogesterone may limit both the venous thromboembolic risk associated with oral estrogens and the risk of breast cancer associated with synthetic progestins. Treatment should be individualized to each woman, by using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of its benefit-risk balance. For bothersome genitourinary syndrome of menopause (GSM) symptoms, vaginal treatment with lubricants and moisturizers is recommended as first-line treatment together with low-dose vaginal estrogen therapy, depending on the clinical course. No recommendation of an optimal duration of MHT can be made, but it must take into consideration the initial indication for MHT as well as each woman's benefit-risk balance. Management of gynecological side-effects of MHT is also examined. These recommendations are endorsed by the Groupe d'Etude sur la Ménopause et le Vieillissement hormonal (GEMVI) and the Collège National des Gynécologues-Obstétriciens Français (CNGOF).

Evaluation of obstetric management of women with macrosomic foetuses in two Level 3 maternity hospitals in France and identification of predictive factors for obstetric and neonatal complications.

OBJECTIVE: Foetal macrosomia is associated with high maternal and neonatal morbidity; however, obstetric management of suspected macrosomia has not been well defined. This study aimed to analyse obstetric management in a population of women who delivered macrosomic new-borns and assess maternal and neonatal outcomes and risk factors for complications in such cases. STUDY DESIGN: This two-centre retrospective study conducted in France over a 10-year period comprised 1724 women who had delivered macrosomic new-borns (defined as those whose weight was > 90th percentile according to the Association of Users of Computerised Records in Perinatology, Obstetrics, and Gynaecology curve) from 37SA. RESULTS: In this study, the caesarean section and instrumental extraction rates were 24.1% and 15.7%, respectively, and the postpartum haemorrhage rate was 7%. The rate of shoulder dystocia was 23.1% (including brachial plexus injuries, 0.4%; and clavicular fractures, 2.0%). Significant risk factors for caesarean section were maternal height < 160 cm, nulliparity, history of caesarean section, excessive uterine height, induction of labour and duration of labour > 10 h. The risk factors for shoulder dystocia were maternal height < 160 cm and instrumental extraction. CONCLUSION: The study findings may help determine predictive factors for an unfavourable outcome at the time of delivery of a macrosomic foetus, thus allowing clinical teams to better anticipate and manage potential complications.

[Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF)]. / Prise en charge des ménorragies : recommandations pour la pratique clinique du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège national des gynécologues et obstétriciens français (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice. CONCLUSIONS: The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.

Surgical techniques for the removal of Essure® microinserts: a literature review on current practice.

PURPOSE: To evaluate the different techniques for Essure® microinserts removal and to assess the risk of fracture of the device and the intra- and post-operative complications in relation to surgical technique variants. METHODS: Electronic search in Medline, Scopus and Embase databases using the following keywords: Essure; Essure removal; Essure surgical technique. RESULTS: Out of 95 articles in the initial database, 17 studies were eligible for inclusion in our literature review. Several surgical techniques have been described in which the most frequent were laparoscopic salpingectomy (LS), laparoscopic cornuectomy (LC), laparoscopic or vaginal hysterectomy (LH, VH) with en-bloc salpingectomy. There were more fractures of the device with the LS procedure (6.25%) followed by the LC technique (2.77%), while there was no fracture with hysterectomy. However, peri-and post-operative complications were more severe and frequent with hysterectomy in comparison with the LC and LS procedures (respectively 8.1% Clavien Dindo grade 3 for the hysterectomy group, 1.11% for the LC procedure and 0.69% for the LS technique). CONCLUSION: Due to the lack of standardised surgical treatment guidelines, a system of care networks for symptomatic patients with adverse effects related to Essure® headed by specialised centres may offer a suitable and high-quality management with the appropriate removal techniques within two objectives: limiting the risk of fracture (with an en-bloc removal of the Essure® microinserts) and avoiding intra- and post-operative complications.

COMPLETE REMISSION OF MEDICALLY TREATED LUTEINIZED THECOMAS WITH SCLEROSING PERITONITIS.

We describe the first French patient treated for sclerosing peritonitis syndrome associated with lutheinized thecomas. At 42 years old, she had respiratory distress with increased abdominal volume. Physical examination revealed ascites, pleural effusions, and two mobile latero-uterine masses. Radiological examinations revealed bilateral ovarian masses of 10 cm. Bilateral adnexectomy was performed by laparotomy. Histological analysis concluded that there were benign luteinized thecomas. Until the 36th postoperative day, the general condition of the patient deteriorated to become critical. A second surgical procedure was attempted revealing sclerosing fibrosis preventing access to the peritoneal cavity. Subsequently, a medical treatment combining parenteral nutrition, high intravenous doses of corticosteroids, antiestrogens, colchicine and sandostatin was administered and effective allowing continuity recovery 15 months later. The clinical outcomes has been favorable at 24 month later.

Influence of the external cephalic version attempt on the Cesarean section rate: experience of a type 3 maternity hospital in France.

PURPOSE: To define the effects of attempted external cephalic version (ECV) in a low-risk population for breech delivery in a maternity hospital where breech vaginal delivery is widely practiced. MATERIALS AND METHODS: Retrospective exposed-unexposed study including 204 patients presented with a live singleton fetus breech presentation on third-trimester ultrasound and who delivered at Reims University Hospital between January 1st, 2013 and July 1st, 2018. RESULTS: 121 patients received ECV. Cesarean section rate was lower (OR with no adjustment 0.42 [0.24-0.76] p = 0.004) but without significant difference in the exposed patients after adjustment. This difference was significant between exposed and unexposed patients in the subgroup of 51 primiparous (OR = 0.14 [0.04-0.52] p = 0.002) and 51 multiparous (OR = 0.26 [0.08-0.89] p = 0.028) but not in the subgroup of 102 nulliparous. There was no difference in fetal impact other than neonatal management in the delivery room, which is less needed in exposed primiparous women. Attempted ECV significantly decreased the breech rate (72.5 vs 100%, p < 0.001). There were 7 (5.79%) complications. Three factors favored success: high uterine height (p = 0.011), a non-elevated BMI (p = 0.006) and an earlier term at ECV (p = 0.003). CONCLUSION: The attempt of ECV in the Reims University Hospital does not significantly reduce the Cesarean section rate and has no effect on neonatal status.

Risk factors for recurrence of borderline ovarian tumors in France: A multicenter retrospective study by the FRANCOGYN group.

INTRODUCTION: Borderline ovarian tumors (BOTs) although rare, have shown an increase in the incidence worldwide. Although the survival rate is high, the recurrence rate is estimated to be between 5% and 34%. The objective of this study was to identify risk factors for recurrence of BOTs. METHODS: This retrospective multicenter study included 493 patients treated surgically for BOT between January 2001 and December 2018. RESULTS: Thirty-seven patients showed recurrence (group R, 7.5%), while 456 did not (group NR, 92.5%). With an average follow-up of 30.5 months (1-276), the overall recurrence rate was 7.5%. Recurrence rates for the BOT and invasive types were 5.7% (n = 28) and 1.4% (n = 7), respectively. The mean time to recurrence was 44.1 (3-251) months. Univariate analysis showed that age at diagnosis, type of surgical procedure, histological type, and FIGO stage were factors influencing recurrence. Multivariate analysis showed that the risk factors for recurrence of BOT were conservative treatment (OR = 7 [95% CI 3.01-16.23]; p < 0.05) and advanced FIGO stage (OR = 5.86 [95% CI 2.21-15.5]; p < 0.05). DISCUSSION: To the best of our knowledge, this multicenter study was one of the largest studies on the risk factors for BOT recurrence. Conservative treatment and advanced FIGO stage were identified as risk factors for BOT recurrence. These results reinforce the need for restaging of patients who did not have an optimal initial surgical staging so as not to avoid missing a tumor in the advanced stage. Referral to a surgical oncology center is suggested to optimize overall patient management.

Prognostic Value and Risk Factors of Peritoneal Carcinomatosis Recurrence for Patients with Endometrial Cancer: A Multicenter Study from the FRANCOGYN Group.

BACKGROUND: The prognosis for patients with endometrial cancer (EC) peritoneal carcinomatosis (PC) recurrence has received little study. This study aimed to determine specific risk factors and prognosis of EC with PC recurrence (PCR) versus no PC recurrence (NPCR). METHODS: Data of all patients with EC who received primary surgical treatment between January 2000 and February 2017 were abstracted from the French FRANCOGYN Research Group database. Clinical and pathologic variables were compared between the two groups (PCR vs. NPCR). Multivariate analysis was performed to define prognostic factors for peritoneal recurrence. Overall survivals (OS) of patients after recurrence were compared using the Kaplan-Meier method. RESULTS: The study analyzed 1466 patients, and 257 of these patients (17.5%) had recurrence. At presentation, 63 of these patients had PC. International Federation of Gynecology and Obstetrics (FIGO) stages 3 and 4 disease were significantly associated with PCR versus NPCR (odds ratio 2.24; 95% confidence interval 1.23-4.07; p = 0.008). The death rate for the patients with PC was 47.6%, with a median survival of 12 months after diagnosis of recurrence. According to the histologic subtype, OS was 29 months (Q1-Q3, 13-NA) for endometrioid carcinomas, 7.5 months (Q1-Q3, 4-15) for serous carcinomas, and 10 months (Q1-Q3, 5-15) for clear cell carcinomas. Chemotherapy for treatment of PCR was associated with improved OS after recurrence (OSAR; p = 0.0025). CONCLUSION: An initial advanced stage of EC is a risk factor for PCR. For women with PCR, a diagnosis of type 1 EC recurrence more than 12 months after the initial treatment and management of PCR with chemotherapy is associated with improved OSAR. Prospective studies are needed to determine the precise optimal management required in this clinical situation and to assess the relevance of biomarkers to predict the risk of PCR for EC patients.

Management of borderline ovarian tumours during pregnancy: Results of a French multi-centre study.

OBJECTIVE: To assess the diagnostic and prognostic characteristics of borderline ovarian tumours (BOTs) detected during pregnancy, and to establish an inventory of French practices. MATERIALS AND METHODS: A retrospective multi-centre case study of 14 patients treated for BOTs, diagnosed during pregnancy between 2005 and 2017, in five French pelvic cancerology expert centres, including data on clinical characteristics, histological tumour characteristics, surgical procedure, adjuvant treatments, follow-up and fertility. RESULTS: The mean age of patients was 29.3 [standard deviation (SD) 6.2] years. Most BOTs were diagnosed on ultrasonography in the first trimester (85.7 %), and most of these cases (78.5 %) also underwent magnetic resonance imaging to confirm the diagnosis (true positives 54.5 %). Most patients underwent surgery during pregnancy (57 %), with complete staging surgery in two cases (14.3 %). Laparoscopy was performed more frequently than other procedures (50 %), and unilateral adnexectomy was more common than cystectomy (57.5 %). Tumour size influenced the surgical approach significantly (mean size 7.5 cm for laparoscopy, 11.9 cm for laparoconversion, 14 cm for primary laparotomy; P = 0.08), but the type of resection did not. Most patients were initially diagnosed with International Federation of Gynecology and Obstetrics stage IA (92.8 %) tumours, but many were upstaged after complete restaging surgery (57.1 %). Most BOTs were serous (50 %), two cases had a micropapillary component (28.5 %), and one case had a micro-invasive implant. BOTs were bilateral in two cases (14.2 %). Mean follow-up was 31.4 (SD 14.8) months. Recurrent lesions occurred in two patients (14.2 %) and no deaths have been recorded to date among the study population. CONCLUSION: BOTs remain rare, but this study - despite its small sample size - supports the hypothesis that BOTs during pregnancy have potentially aggressive characteristics.

[Prognostic significance of groin lymph node ratio in vulvar squamous cell carcinoma]. / Signification pronostique du ratio d'atteinte ganglionnaire inguinale dans le carcinome épidermoide vulvaire.

OBJECTIVES: The aim was to review the clinical impact of lymph node ratio (LNR) of groin metastatic nodal disease in women with vulvar squamous cell carcinoma. MATERIAL AND METHODS: Cohort study of women with vulvar squamous cell carcinoma, managed between January 2005 and December 2015, in five institutions in France with prospectively maintained databases (French multicenter tertiary care centers). POPULATION: In total, 636 women managed for VSCC of whom 508 (79.9%) underwent surgical groin nodal staging. MAIN OUTCOME MEASURES: Comparison of overall and recurrence free survival between women according to LNR. RESULTS: In total, 176 women (34.6%) had at least one positive lymph node (LN). There was a significant differences for the 5-year overall survival and recurrence free survival rates between women with LNR>0.2 and women with LNR<0.2. CONCLUSION: LNR seems to be a significant prognostic factor in women with vulvar squamous cell carcinoma.

[Guidelines for surgical management of gynaecological cancer during pandemic COVID-19 period - FRANCOGYN group for the CNGOF]. / Prise en charge chirurgicale des cancers gynécologiques en période de pandémie COVID-19 ­ Recommandations du Groupe FRANCOGYN pour le CNGOF.

INTRODUCTION: Recommendations for the management of patients with gynecological cancer during the COVID-19 pandemic period. MATERIAL AND METHOD: Recommendations based on the consensus conference model. RESULTS: In the case of a COVID-19 positive patient, surgical management should be postponed for at least 15 days. For cervical cancer, the place of surgery must be re-evaluated in relation to radiotherapy and Radio-Chemotherapy-Concomitant and the value of lymph node staging surgeries must be reviewed on a case-by-case basis. For advanced ovarian cancers, neo-adjuvant chemotherapy should be favored even if primary cytoreduction surgery could be envisaged. It is lawful not to offer hyperthermic intraperitoneal chemotherapy during a COVID-19 pandemic. In the case of patients who must undergo interval surgery, it is possible to continue the chemotherapy and to offer surgery after 6 cycles of chemotherapy. For early stage endometrial cancer, in case of low and intermediate preoperative ESMO risk, hysterectomy with bilateral annexectomy associated with a sentinel lymph node procedure should be favored. It is possible to consider postponing surgery for 1 to 2 months in low-risk endometrial cancers (FIGO Ia stage on MRI and grade 1-2 endometrioid cancer on endometrial biopsy). For high ESMO risk, it ispossible to favor the MSKCC algorithm (combining PET-CT and sentinel lymph node biopsy) in order to omit pelvic and lumbar-aortic lymphadenectomies. CONCLUSION: During COVID-19 pandemic, patients suffering from cancer should not lose life chance, while limiting the risks associated with the virus.

Gynecology-obstetric resident surgery training: a national evaluation.

OBJECTIVES: The main objective of this study was to evaluate surgery training and evaluation of French gynecology-obstetrics residents. The second objective was to evaluate using simulation during residency. STUDY DESIGN: This national descriptive study, utilized a questionnaire to survey all interns in French gynecology and obstetrics. At the end of a study, 129 responses of residents were analyzed. RESULTS: The participation rate was 12%. The majority of residents were women (84%) and the highest response rate was from the Ile-de-France region (36%). The lowest rate was from the Southern region. The majority of residents were in the eighth semester (20%). Residents reported surgical and obstetric orientations in 53% (n = 68) and 44% (n = 57) of cases, respectively. Registration for cancer oncology was reported by 22% (n = 28) of respondents. Evaluation of oncologic surgery training was mostly considered "good" by the surgical group and "passable" by the obstetrics group. Access to simulators was usually restricted and most often utilized the pelvitrainer. Sessions were typically not mandatory and numbered between zero and five per semester. Three types of simulators were accessible in the Ile-de-France, North-West, West and Rhône-Alpes. The North-East did not have access to animal models, and the South-West did not have access to corpses. Surgical classes were more common in the Rhône-Alpes, North-East, Ile-de-France and North-West regions. To improve their training in oncological surgery, 64% (n = 18) of residents planned to do an inter-university exchange and 54% had completed additional specialized training. Measures that were most expected to improve training were increased training in surgery (96% of respondents, n = 27) and more intensive coaching (96%, n = 27). CONCLUSIONS: Companionship is a pillar of residents training, but its effectiveness is variable. One solution could be to implement better use of simulation methods.

Surgical treatment of vulvar cancer: Impact of tumor-free margin distance on recurrence and survival. A multicentre cohort analysis from the francogyn study group.

OBJECTIVE: In vulvar cancer, it is admitted that tumor-free margin distance is one of the most important element for locoregional control. It is currently recommended to surgically remove the tumor with at least an 8 mm tumor-free margin. The aim of this study was to evaluate the impact of tumor-free margin distance on recurrence and survival in vulvar cancer. MATERIAL AND METHODS: From 2005 to 2016, 112 patients surgically treated for a vulvar squamous cell cancer were included in a retrospective multicenter study. Overall, disease-free and metastasis-free survivals were analyzed according to tumor-free margin distance. RESULTS: Patients were divided into three groups: group 1 (margin <3 mm, n = 47); group 2 (margin ≥3 mm to < 8 mm, n = 48) and group 3 (margin ≥8 mm, n = 17). During the study, 26,8% patients developed recurrence (n = 30) after a median of 8 months (1-69). Analysis of 5-year overall survival, as well as disease-free and metastasis-free survivals, did not reveal a difference between groups. We performed a subgroup analysis in patients with a tumor-free margin <8 mm (group 1 and 2). It showed that histological lesions observed closest to the edge of the specimen were more often invasive or in situ carcinoma lesions in group 1 than in group 2, in which VIN lesions were mainly observed at this location. After re-excision, no patients in group 1 and 50% (n = 2) patients in group 2 developed recurrence. CONCLUSION: This study did not reveal a significant impact of tumor-free margin distance on recurrence and survival in vulvar cancer. Moreover, the benefit of re-excision seems stronger when tumor-free margins are positive or very close (<3 mm), cases in which invasive or in situ lesions are often present closest to the edge of the specimen.