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 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.

[Continuous/extended/flexible use of combined hormonal contraceptives: Prescribing habits of practitioners in Centre Val deLoire region]. / Prescription de contraception æstro-progestative en schéma continu/étendu/flexible : étude de pratique professionnelle dans la région Centre Val de Loire.

OBJECTIVES: To date, oral contraceptives remain the most frequently prescribed contraceptive method. New combined oral contraceptive (COC) regimens (continued, extended or flexible) were developed to try and space out or avoid withdrawal bleedings in order to meet women's expectations and improve their quality of life. However, there is no recommendation published regarding the management of the prescription. The purpose of our study was to describe provider's prescription habits when it comes to new COC regimens. METHODS: This is a descriptive observational study. A questionnaire was sent to gynecologists, general practitioners and midwives employed or in training in the Centre Valde Loire region. Prescription habits and knowledge about new oral contraceptive regimens were evaluated. RESULTS: 83% of health professionals frequently prescribed new COC regimens. Most frequent indications were endometriosis, severe menstruation-associated symptoms, patient's desire for amenorrhea or patient's request. The extended regimen (hormone-free interval not every month) was the most frequently used. Provider's knowledge about indications and benefits of those new regimens were satisfactory. However, scientific societies guidelines were poorly acquired. CONCLUSIONS: New COC regimens are frequently proposed by health care professionals with large variability in terms of prescription model. Along with reinforcement of COC prescription guidelines for healthcare professionals, further researches are needed to better understand differences in tolerability and acceptability in terms of quality of life of the several potential regimens.

Prise en charge des ménorragies : recommandations pour la pratique clinique du Collège National des Gynécologues et Obstétriciens Français (CNGOF) [Pré-print] / Management of women with abnormal uterine bleeding: clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF) [Pré-print]

Émettre des recommandations pour la prise en charge des femmes ayant des ménorragies. Un comité de 26 experts a été constitué. Une politique de déclaration et de suivi des liens d'intérêts a été appliquée et respectée durant tout le processus de réalisation du référentiel. De même, celui-ci n'a bénéficié d'aucun financement provenant d'une entreprise commercialisant un produit de santé (médicament ou dispositif médical). Le comité devait respecter et suivre la méthode GRADE® (Grading of Recommendations Assessment, Development and Evaluation) pour évaluer la qualité des données factuelles sur lesquelles étaient fondées les recommandations. Les dernières recommandations du Collège National des Gynécologues et Obstétriciens Français (CNGOF) sur la prise en charge des femmes ayant des ménorragies ont été publiées en 2008. Nous avons souhaité réactualiser ces recommandations selon la méthodologie GRADE® en identifiant 7 champs différents (diagnostic ; adolescente ; ménorragies idiopathiques ; hyperplasie et polype de l'endomètre ; myomes de type 0 à 2 ; myomes de type 3 et plus ; adénomyose). Chaque question a été formulée selon le format PICO (Patients, Intervention, Comparison, Outcome). L'analyse de la littérature et les recommandations ont été formulées selon la méthodologie GRADE. Le travail de synthèse des experts et l'application de la méthode GRADE ont abouti à 36 recommandations. Parmi les recommandations, 19 ont été établies avec un accord fort et 17 avec un accord faible. Il n'a pas été possible de statuer pour 14 questions pour lesquelles nous avons préféré nous abstenir plutôt que de fournir des avis d'experts.Les 36 recommandations ont permis de préciser les stratégies diagnostiques et thérapeutiques des différentes situations cliniques des plus simples au plus complexes rencontrées par le praticien.

To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). 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. 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. 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. 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.

[CNGOF clinical practice guidelines: Evaluation one year after revision of the methodology]. / Recommandations pour la pratique clinique du CNGOF : évaluation un an après révision de la méthodologie.

OBJECTIVES: To evaluate the revision of methodology of the clinical practice guidelines (CPG) of the French National College of Gynecologists and Obstetricians (CNGOF). METHOD: Three CPGs were organized in 2020 on the topics of severe preeclampsia, menorrhagia, and prophylactic surgery according to AGREE II (Apraisal of Guidelines for Research & Evaluation). Questions were presented in PICO (Population, Intervention, Comparison, Outcome) format and the grading of scientific evidence was based on the GRADE (Grading of Recommendation Assessment, Development and Evaluation) method. RESULTS: All three CPGs groups adhered to this new methodology. However, the presentation of the arguments, the formulation of the recommendations and the development of the GRADE tables were heterogeneous from one group to another. A homogenization of the presentation is proposed, as well as a guide to the critical analysis of the literature to help the experts to rate the evidence. CONCLUSION: Adherence to these quality criteria should make it easier to apply the recommendations at the national level and improve international recognition of the work done by the CNGOF.

[Contraception: CNGOF Guidelines for Clinical Practice (Short Version)]. / Contraception : Recommandations pour la Pratique Clinique du CNGOF (texte court).

The French College of Obstetrics and Gynecology (CNGOF) releases its first global recommendations for clinical practice in contraception, to provide physicians with an updated synthesis of available data as a basis for their practice. The French Health Authority (HAS) methodology was used. Twelve practical issues were selected by the organizing committee and the task force members. The available literature was screened until December 2017, and allowed the release of evidence-based, graded recommendations. This synthesis is issued from 12 developed texts, previously reviewed by experts and physicians from public and private practices, with an experience in the contraceptive field. Male and female sterilization, as well as the use of hormonal treatments without contraceptive label were excluded from the field of this analysis. Specific practical recommendations on the management of contraception prescription, patient information including efficacy, risks, and benefits of the different contraception methods, follow up, intrauterine contraception, emergency contraception, local and natural methods, contraception in teenagers and after 40, contraception in vascular high-risk situations, and in case of cancer risk are provided. The short/mid-term future of contraception mostly relies on improving the use of currently available methods. This includes reinforced information for users and increased access to contraception for women, whatever the social and clinical context. That is the goal of these recommendations.

[Primary management of endometrial carcinoma. Joint recommendations of the French society of gynecologic oncology (SFOG) and of the French college of obstetricians and gynecologists (CNGOF)]. / Prise en charge primaire des cancers de l'endomètre : recommandations SFOG-CNGOF.

OBJECTIVES: The management of endometrial carcinoma is constantly evolving. The SFOG and the CNGOF decided to jointly update the previous French recommendations (Institut national du cancer 2011) and to adapt to the French practice the 2015 recommendations elaborated at the time of joint European consensus conference with the participation of the three concerned European societies (ESGO, ESTRO, ESMO). MATERIAL AND METHODS: A strict methodology was used. A steering committee was put together. A systematic review of the literature since 2011 has been carried out. A first draft of the recommendations has been elaborated, with emphasis on high level of evidence. An external review by users representing all the concerned discipines and all kinds of practice was completed. Three hundred and four comments were sent by 54 reviewers. RESULTS: The management of endometrial carcinoma requires a precise preoperative workup. A provisional estimate of the final stage is provided. This estimation impact the level of surgical staging. Surgery should use a minimal invasive approach. The final pathology is the key of the decision concerning adjuvant therapy, which involves surveillance, radiation therapy, brachytherapy, or chemotherapy. CONCLUSION: The management algorithms allow a fast, state of the art based, answer to the clinical questions raised by the management of endometrial cancer. They must be used only in the setting of a multidisciplinary team at all stages of the management.

[Clinical practice guidelines: Synthesis of the guidelines for the surgical treatment of primary pelvic organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. / Recommandations pour la pratique clinique : synthèse des recommandations pour le traitement chirurgical du prolapsus génital non récidivé de la femme par l'AFU, le CNGOF, la SIFUD-PP, la SNFCP, et la SCGP.

OBJECTIVE: Develop guidelines for surgery for primary pelvic organ prolapse (POP). METHODS: Literature review, establishment of levels of evidence, external review, and grading of recommendations by 5 French academic societies: Association Française d'Urologie, Collège National des Gynécologues et Obstétriciens Français, Société Interdisciplinaire d'Urodynamique et de Pelvi-Périnéologie, Société Nationale Française de Colo-proctologie, and Société de Chirurgie Gynécologique et Pelvienne. RESULTS: It is useful to evaluate symptoms, their impact, women's expectations, and to describe the prolapse prior to surgery (grade C). In the absence of any spontaneous or occult urinary sign, there is no reason to perform urodynamics (grade C). When a sacrocolpopexy is indicated, laparoscopy is recommended (grade B). A bowel preparation before vaginal (grade B) or abdominal surgery (grade C) is not recommended. There is no argument to systematically use a rectovaginal mesh to prevent rectocele (grade C). The use of a vesicovaginal mesh by vaginal route should be discussed taking into account an uncertain long-term risk-benefit ratio (grade B). Levator myorrhaphy is not recommended as a first-line rectocele treatment (grade C). There is no indication for a vaginal mesh as a first-line rectocele treatment (grade C). There is no reason to systematically perform a hysterectomy during prolapse repair (grade C). It is possible to not treat stress incontinence at the time of prolapse repair, if the woman is advised of the possibility of a 2-step surgical treatment (grade C).

[Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. / Recommandations pour la pratique clinique : Synthèse des recommandations pour le traitement chirurgical du prolapsus génital non récidivé de la femme par l´AFU, le CNGOF, la SIFUD-PP, la SNFCP et la SCGP.

OBJECTIVE: Providing clinical practice guidelines for first surgical treatment of female pelvic organ prolapse. METHODS: Systematic literature review, level of evidence rating, external proofreading, and grading of recommendations by 5 French academic societies: Association française d'urologie, Collège national des gynécologues et obstétriciens français, Société interdisciplinaire d'urodynamique et de pelvi-périnéologie, Société nationale française de coloproctologie, and Société de chirurgie gynécologique et pelvienne. RESULTS: It is useful to evaluate symptoms, their impact, women's expectations, and to describe the prolapse prior to surgery (Grade C). In the absence of any spontaneous or occult urinary sign, there is no reason to perform urodynamics (Grade C). When a sacrocolpopexy is indicated, laparoscopy is recommended (Grade B). A bowel preparation before vaginal (Grade B) or abdominal surgery (Grade C) is not recommended. There is no argument to systematically use a rectovaginal mesh to prevent rectocele (Grade C). The use of a vesicovaginal mesh by vaginal route should be discussed taking into account an uncertain long-term risk-benefit ratio (Grade B). Levator myorrhaphy is not recommended as a first-line rectocele treatment (Grade C). There is no indication for a vaginal mesh as a first-line rectocele treatment (Grade C). There is no reason to systematically perform a hysterectomy during prolapse repair (Grade C). It is possible to not treat stress incontinence at the time of prolapse repair, if the woman is advised of the possibility of a 2-step surgical treatment (Grade C). Clinical practice guidelines. © 2016 Published by Elsevier Masson SAS.

[Safety profile of etonogestrel contraceptive implant (Nexplanon® and Implanon®) reported in France]. / Profil des effets indésirables de l'implant d'étonogestrel (Nexplanon®, Implanon®) déclarés en France.

OBJECTIVES: The aim of the study was to assess the incidence of adverse effects (AE) reported with etonogestrel contraceptive implant in France (Implanon® and Nexplanon®). MATERIALS AND METHODS: All cases of AE or unintended pregnancies reported to health authorities or to the firm were analyzed. RESULTS: During 10 years, 5433 AE and 789 unintended pregnancies were reported. Only 388 (7 %) were serious. There were 1137 reports of difficulties to remove, failure to locate or migration, 430 of insertion difficulties and 203 of deformation or expulsion of the implant. Among other AE, the most common were 1694 gynecological AE, 524 skin reactions and 437 metabolic AE. Since the marketing of Nexplanon® which causes less deep insertions, the incidence of migrations, removal or insertion difficulties has decreased overall (0.92 vs. 1.31/1000 patients), particularly the incidence of removal difficulties, location failures or migrations (0.12 vs 1.01/1000). The infrequent but serious AE were infectious complications at the implant site and pregnancies. When the circumstances of the pregnancy were known, the contraceptive failure was due to the apparent inefficiency of the implant (n=224), to a technique failure (n=203) or to a drug-drug interaction (n=59). CONCLUSION: This study confirms that AE of this implant are frequent but not serious, except for the pregnancies. The incidence of complications related to insertion decreased with Nexplanon®. Among other preventable AE, unintended pregnancies due to a drug-drug interaction would require to be better known by the practitioner.

Is there a justification for hysterectomy in patients with borderline ovarian tumors?

OBJECTIVE: To determine the frequency of uterine involvement in patients with borderline ovarian tumors (BOT) and to evaluate the recurrence risk and survival after hysterectomy. MATERIALS AND METHODS: In two French hospitals: A tertiary referral centre (University hospital centre of Tours, France) and the Alliance community hospital of Tours (France), we reviewed data of consecutive women undergoing surgery for presumed stage I BOT between January 1997 and December 2012. Patients were divided into two groups: patients treated with fertility sparing surgery (group 1) and those treated with radical surgery (group 2). RESULTS: A total of 135 patients were evaluated. 35 had fertility sparing surgery, 81 had radical surgery with hysterectomy and 19 had previous hysterectomy for other reasons. There were more recurrent borderline ovarian disease and more ovarian invasive disease developed in group 1 (p = 0.02, p = 0.04, respectively). Hysterectomy affected favorably borderline disease-free survival, OR = 0.09 95%CI (0.005-0.69), p = 0.04, but perceived benefits may be related to bilateral salpingo-oophorectomy and not hysterectomy directly.

[Treatment of vulvar intra-epithelial neoplasias with Imiquimod]. / Traitement des néoplasies vulvaires intra-épithéliales par imiquimod.

The incidence of vulvar intra-epithelial neoplasia (VIN) is increasing in the developed countries especially in young women. There is little consensus regarding the optimal management. Surgery used to be the gold standard. Alternatives to surgery are now needed for the treatment of VIN. Many studies investigated the effectiveness of Imiquimod 5% cream in this pathology. We present a literature review of the results published on the subject.

[Robotic assisted laparoscopy: comparison of segmentary colorectal resection and shaving for colorectal endometriosis]. / Laparoscopie robot-assistée pour endométriose colorectale: morbidité de la résection digestive et du shaving.

OBJECTIVES: To compare perioperative complications of two surgical methods for digestive endometriosis management: "shaving" and colorectal resection in robotic-assisted laparoscopy. METHODS: Twenty-eight women underwent robotic-assisted laparoscopy for digestive endometriosis, confirmed histologically. Six women had a digestive resection and twenty-one women had a shaving procedure. Short-term and long-term results and complications were compared between the two groups. RESULTS: Operative time was significantly shorter (P=0.0002) and estimated blood loss was significantly lower (200 ml vs 560 ml, P=0.04) in the shaving procedure group in comparison with the resection group. We observed one conversion to laparotomy in the resection group and one case of bladder injury in the shaving group. Length of hospital stay was longer (P=0.0001) in the resection group than in the shaving group. At the two-month re-evaluation, there was no significant difference between the two groups for the number of women in full remission for pelvic pain, urinary or gastrointestinal symptoms or dyspareunia. Two women of the resection group reported functional gastrointestinal signs that persisted 24 months after the intervention. CONCLUSION: Both immediate and delayed operative morbidity are more frequent in case of resection. Surgery for deep infiltrating endometriosis, even if operated with robotic assisted laparoscopy, is associated with significant morbidity.

[Evidence-based evaluation and expertise of methotrexate off label use in gynaecology and obstetrics: work of the CNGOF]. / États des lieux et expertise de l'usage hors AMM du méthotrexate en gynécologie-obstétrique: travail du CNGOF.

In the absence of contraindication, methotrexate by intramuscular unique injection of 1mg/kg or 50mg/m(2) is the medical treatment recommended for tubal ectopic pregnancy (EP; LE1). It can be renewed once, at the same dose, according to hCG rates decrease. The pretherapeutic biological assessment contains blood cells numeration, renal and hepatic function. Methotrexate therapy constitutes an alternative conservative treatment to laparoscopic salpingotomy for non-complicated tubal EP (LE1) with hCG level <5000 UI/L (LE2). When the rates of hCG are <1000 UI and or presented a spontaneous decreasing kinetics, the simple prospect (LE2) is preferred. It is recommended to use intramuscular methotrexate in case of surgical conservative treatment failure or more prematurely if the follow-up is not possible (LE3). Except in particular cases there is no indication to use methotrexate in local injection under sonographic control in usual tubal EP (LE2). The use of in situ injection methotrexate is an option to handle the cervical, interstitial or on caesareans scar pregnancies (LE2). In front of a persistent undetermined location pregnancy, after more than 10 days of survey, in an asymptomatic woman and/or at rate of hCG >2000 UI/L, the systematic treatment by methotrexate is an option. The methotrexate is not indicated for first trimester termination of pregnancy or miscarriage neither in placentas accreta nor in association with other treatments such myfegine or potassium.