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.

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.

Symptom related to Essure® and evolution after removal: Outcomes of retrospective cohort.

INTRODUCTION: The number of requests for Essure removal has grown continually over recent years. The objective is to describe the symptoms reported after Essure sterilization, methods of removal and results. MATERIAL AND METHODS: Retrospective and single-centre cohort (Regional university hospital of Lille, France) was conducted. All women, having consulted from December 2016 to February 2019 for symptoms related to Essure insertion, were included. All the symptoms were noted. A second group was created that included patients who underwent Essure removal to evaluate the benefits of surgery on these symptoms. RESULTS: The study included 98 patients. Most frequent symptoms were musculoskeletal pain (75 %), asthenia (63 %) and pelvic pain (55 %). Fifty-nine patients (60 %) underwent surgery. Surgery appeared beneficial with reduction of symptoms in 60 % of these patients, complete resolution in 33 % and no reduction of symptoms in 7%. Many symptoms were relieved by surgery with an overall decline of 96 % in menorrhagia, 94 % in metrorrhagia and 93 % in dyspareunia. However, other symptoms were not relieved by surgery like 100 % of sleep disorders, 70 % of abdominal pain cases and 57 % of memory impairment cases. CONCLUSION: Symptoms related to Essure insertion are numerous. Although surgery appears beneficial, some adverse effects remain. Therefore, a preoperative aetiologic assessment and information about risk of surgery failure are important.

Feasibility of vaginal mesh for anterior vaginal wall prolapse in an ambulatory setting: A retrospective case series.

INTRODUCTION: Vaginal mesh has been proven to be an effective aid in the treatment of cystocele. Could an ambulatory approach be feasible for the Uphold Lite®-mesh? HYPOTHESIS: We investigate the feasibility of an ambulatory approach of Uphold Lite® insertion in a well-selected population. Risk factors for a non-successful ambulatory approach are identified. METHODOLOGY: We conducted a retrospective case series of 236 women who underwent Uphold Lite® vaginal mesh insertion for the treatment of pelvic organ prolapse at our center. Indications for surgery were symptomatic anterior and/or apical prolapse, stages POPQ≥2. We compared women having an ambulatory approach, to those having a one day hospitalization planned but needed to stay. Comparisons between percentages were calculated using the chi-square or Fisher's exact test, depending on the number of women in each group. The mean comparisons were performed using the Student t-test, and the median test comparisons by the Kruskal-Wallis test. A difference was considered significant if p<0.05. RESULTS: The most common reason for staying (85.7% of all ambulatory failures) after Uphold® surgery is the presence of an elevated post void residual. This complication was more found in the following: surgery in the afternoon, use of high-dose morphinics in general anesthesia, and in women with a higher parity. CONCLUSIONS: Our study shows that Uphold® surgery in a one-day setting is feasible and safe. Women desiring this approach should be counselled on the 42.6% risk of one-day failure though, mostly due to non-validation of a post void residual. General anesthesia with high-dose morphinics, a higher parity, and surgery in the afternoon are risk factors for failure of an ambulatory protocol.

Disappearance of a myoma after pregnancy in a 38 years old patient, treated by ulipristal acetate without success before getting pregnant.

Uterine fibroids are the most common form of benign gynaecological tumors in women of childbearing age Piecak et al. (2017) [1]. These uterine fibroids can be responsible for abnormal uterine bleeding, pelvic pain, pelvic pressure and infertility Pritts et al. (2009), Ali and Al-Hendy (2017) [2,3]. Their treatment can be carried out according to several methods: medical treatment, uterine artery embolization or surgery (myomectomy or hysterectomy). Although surgery is the main option, there are medical treatments to reduce their size and decrease and control their symptoms. Ulipristal acetate (UPA) has been the first selective progesterone-receptor modulator approved for the preoperative and long-term treatment for uterine fibroids Ferrero et al. (2018) [4]. Here we present the case of a 38-years-old patient whose large fibroma (initially treated with UPA) totally disappeared after pregnancy.

Outpatient vaginal hysterectomy: Comparison of conventional suture ligature versus electrosurgical bipolar vessel sealing.

OBJECTIVE: The aim of our study was to evaluate the feasibility of vaginal hysterectomy in an ambulatory care system and the best way to perform it between conventional and bipolar vessel sealing system ligatures. PATIENTS AND METHODS: This was a prospective study of 32 patients with vaginal hysterectomy at Lille University Hospital between December 2013 and May 2015. Two surgical techniques were compared: conventional suture ligature (CSL) and electrosurgical bipolar vessel sealing (BVS). Patients stayed in classical hospitalization but were managed how if they were in an ambulatory unit to evaluate their capacity to come back home the same evening of the surgery. The evaluation of same-day discharge was based on Post Anesthetic Discharge Scoring System (PADSS) score?9/10 and Visual Analogic Scale (VAS) score?4/10. Other data collected were: operative time, uterus weight, peroperative bleeding, PADSS score at the 8th postoperative hour, VAS score at the 4th, 6th, 8th, 12th and 24th postoperative hours, the presence of postoperative nausea/vomiting and rehospitalization. RESULTS: In the BVS group, 93.8% of patients validated the combined score (PADSS+VAS) on the evening of the intervention against 50% of patients in the CSL group (P<0.05). Hundred percent of BVS group patients were discharged on the day after surgery against 87.5% in the CSL group. The VAS was significantly lower in the BVS group at the 8th (1.4), 12th (1.2) and 24th (1.3) postoperative hours. Operative time was significantly shorter in the BVS group. We found more events such as nausea/vomiting in the CSL group. CONCLUSION: Vaginal hysterectomy is feasible in an ambulatory care system most of times. By reducing postoperative pain, electrosurgical bipolar vessel sealing would promote outpatient hospitalization.

Female pelvic anatomy: Are we there yet? Assessment of the knowledge of residents.

BACKGROUND: Anatomy is considered a keystone in medical education and pelvic anatomy comprehension is the groundwork of the understanding of birthing process and pelvic surgery. The objectives of this study were to assess the state of the knowledge in anatomy of ob/gyn residents. MATERIEL AND METHODS: The assessment of pelvic anatomy knowledge of 52 ob/gyn residents was performed in a cross-sectional analysis in Lille University Hospital in 2015. A survey was designed with educational and clinical objectives on pelvic anatomy to assess the resident's real level of knowledge. RESULTS: Ob/gyn residents were not satisfied with the learning of anatomy at the medical school with a global rate of 92% of unhappy residents. The global score in anatomy for the overall population was 6.67±0.46 (on 20 points). The eldest residents had a significant better global score than the youngest, 9.24±0.76 vs. 5.53±0.46 (P<0.0001). CONCLUSIONS: Ob/gyn residents should be educated to a specific teaching in anatomy throughout their residency program. Some strategies could improve the level of ob/gyn residents in anatomy and the survey showed the attractiveness of residents to modern medias, such as anatomy videos, compared to current historical anatomy lectures human cadaveric dissections or books.

Radiological assessment of the placement of Essure® in order to reduce hysterosalpingography: Pelvic X-ray versus combined pelvic X-ray and ultrasound.

OBJECTIVE: Three months after hysteroscopic sterilisation with Essure®, a confirmation test is required to evaluate the correct location of the inserts. The test may be conducted using a pelvic ultrasound (2D or 3D) or an abdominal X-ray. Should the location not look satisfactory on these tests, a follow-up hysterosalpingography (HSG) would be required. The objective of our study is to assess whether the Essure® 3-month confirmation test using a single X-ray or a combination of X-ray and ultrasound could reduce the use of HSG. STUDY DESIGN: This retrospective study examined patients who underwent birth control Essure® procedure between 2009 and 2015 in the Gynaecological Surgery Department at the Regional University Hospital Centre (CHRU) in Lille. We divided patients into two groups based on the imaging tests performed: single X-ray (2009-2010) versus X-ray and pelvic ultrasound (2014-2015). We then compared the results of the imaging tests and the use of HSG between the two groups. RESULTS: One hundred and thirty-four patients were tested, of which 60 (44.8%) using a single X-ray and 74 (55.2%) using a combination of X-ray and ultrasound. We note that the combined X-ray/ultrasound test reduces significantly the number of HSG performed (26.7% versus 12.2%, P=0.04). CONCLUSION: Compared to a single X-ray, the combination of X-ray and ultrasound enables to significantly limit the use of HSG.

[Quality of life and symptoms before and after surgical treatment of rectovaginal fistula]. / Évaluation de la qualité de vie et des symptômes avant et après prise en charge chirurgicale des fistules rectovaginales.

INTRODUCTION: Rectovaginal fistula requires a complex management because it has an important psychological impact associated with impaired quality of life of patients. Thus, the aim of our study was to evaluate the improvement of the quality of life of patients after surgical management. METHODS: This is a retrospective study. We included patients operated between 2009 and 2014 for the treatment of a rectovaginal fistula, whose data were available and who agreed to answer a questionnaire. We evaluated the satisfaction of short-term and long-term patients on the answer to the basic PFDI-20 and PFIQ-7 questionnaires. We then evaluated whether there was an improvement in symptoms and quality of life after surgery. RESULTS: Nine patients were included but only 4 patients completed the PFDI-20 and PFIQ-7 questionnaires. Fistula was secondary to either surgical intervention (44%, n=4) or complicated perineal tear (44%, n=4) or unknown cause (11%, n=1). After surgery, we found the short term a significant decrease in stool incontinence, as there was no stool incontinence (0/5) in the postoperative period, while preoperatively 55% (5/9) (P=0.03). Postoperatively, 33% (3/9) of the patients had genital discomfort and 44% (4/9) had gas incontinence compared to 0% preoperatively (P=0.2 and P=0.6). There appears to be an improvement in pelvic static disorders after surgical management. However, we found a slight improvement in nauseous leucorrhoea in the immediate postoperative period, as the prevalence decreased from 33% (3/9) preoperatively to 22% (2/9) postoperatively (P>0.9). In the long term, we observed an improvement in the sensation of perineal heaviness and gas incontinence because only 25% (1/4) of the 75% (3/4) preoperative patients still showed slight discomfort (P=0.5). The quality of life and the emotional state of the patients were no altered postoperatively. Indeed, preoperatively, 50% (2/4) of the patients reported anxiety compared to 0% (0/4) postoperatively (P=0.4). Similarly, 75% (3/4) complained of a decrease in their quality of life (social, sports, etc.) preoperatively compared with 0% (0/4) postoperatively (P>0.9). CONCLUSION: A simple surgical management of rectovaginal fistulas would allow a significant decrease in stool incontinence and improved quality of life and their emotional state, which confirms the beneficial effect of this therapeutic strategy. LEVEL OF EVIDENCE: 4.

[Tubo-ovarian abscesses treatment: Faisability and results of trans-vaginal ultrasound-guided aspiration]. / Évaluation de la faisabilité du traitement des abcès tubo-ovariens par ponction trans-vaginale écho-guidée.

OBJECTIVE: Two years after the French guidelines, the objective was to assess the feasibility and efficiency of ultrasound-guided trans-vaginal drainage of tubo-ovarian abscesses (TOA) and to study the responsible germs. MATERIAL AND METHODS: All the patients with a larger abscess than 20mm were included prospectively from May 2011 to July 2014 in the university hospital of Lille. RESULTS: Sixty-nine drainages were performed among 50 patients. Success rate was 94%. No complication occurred. One germ was found in 55% of patients, the TOA was polymicrobian in 20% of cases. CONCLUSION: Ultrasound-guided trans-vaginal drainage of TOA is safe and effective with more than 90% of success rate.

Postoperative pelvic pain: An imaging approach.

Postoperative pelvic pain after gynecological surgery is a readily detected but unspecific sign of complication. Imaging as a complement to physical examination helps establish the etiological diagnosis. In the context of emergency surgery, vascular, urinary and digestive injuries constitute the most frequent intraoperative complications. During the follow-up of patients who had undergone pelvic surgery, imaging should be performed to detect recurrent disease, postoperative fibrosis, adhesions and more specific complications related to prosthetic material. Current guidelines recommend using pelvic ultrasonography as the first line imaging modality whereas the use of pelvic computed tomography and/or magnetic resonance imaging should be restricted to specific situations, depending on local availability of equipment and suspected disease.

How to manage peroperative haemorrhage when vaginally treating genital prolapse.

Surgery of genital prolapse causes haemorrhagic complications in about 1% of cases. The pelvis is highly vascular and accessing the usual landmarks of vaginal surgery, in particular the sciatic spine, is delicate work. Meticulous dissection of closed spaces is often difficult, and exposure and haemostatic procedures will be challenging in the event of any bleeding complication. When fixing prosthesis to the sacrospinous ligament, the inferior gluteal artery and its coccygeal branch are at risk. Fixation to the sacrospinous ligament must be performed more than 25mm away from the sciatic spine and, if possible, must not transfixiate it. Safe insertion of prosthesis requires sufficient experience, and an adequate learning curve. Being aware of vascular anatomy allows one to understand and treat haemorrhagic incidents. Packing or selective embolization seem to be the two methods to adopt, depending on the severity of bleeding and the conditions of exposure on the one hand, and on the technical resources available for embolization, on the other. Hypogastric ligature appears to be ineffective in this context.

3D simulation of pelvic system numerical simulation for a better understanding of the contribution of the uterine ligaments.

INTRODUCTION AND HYPOTHESIS: Genital prolapse remains a complex pathological condition. Physiopathology remains poorly understood, aetiology is multi-factorial, surgery is not always satisfying, as the rate of relapse cannot be overlooked. More over a good anatomical result will not always guarantee functional satisfaction. The aim of our study is to have a better understanding of the involvement of uterine ligaments in pelvic statics via 3D simulation. METHODS: Simulation of pelvic mobility is performed with a validated numerical model in a normal situation (standing up to lying down) or induced pathological ones where parts of the constitutive elements of the model are virtually "cut" independently. Displacements are then discussed. RESULTS: Numerical results have been compared with dynamic MRI for two volunteers. Dynamic sequences had 90 images, and 180 simulations have been validated. Results are coherent with clinical data and the literature, thus validating our mechanical approach. Uterine ligaments are involved in pelvic statics, but their lesions are not sufficient to generate a genital prolapse. Round ligaments play a part in uterine orientation; the utero-sacral ligaments support the uterus when standing up. CONCLUSIONS: Pelvic normal and pathological mobility study via modelling and 3D simulation is a new strategy in understanding the complex multifactorial physiopathology of genital prolapse. This approach must be validated in a larger series of patients. Nevertheless, pelvic ligaments seem to play an important role in statics, especially, in agreement with a literature survey, utero-sacral ligaments in a standing position.

Visually induced postural reactivity is velocity-dependent at low temporal frequencies and frequency-dependent at high temporal frequencies.

Visual stimulation alone is sufficient to produce visually induced postural reactivity (VIPR). While some studies have shown that VIPR increases with the velocity of a moving visual stimulus, others have shown that it decreases with the temporal frequency of an oscillating visual stimulus. These results seem contradictory given that these two variables co-vary in the same direction. The purpose of this study is to determine whether the VIPR can be different depending on the frequency range being considered. Twelve subjects were placed standing up in a virtual reality environment that simulated a black and white checkerboard at floor level. This checkerboard oscillated at seven frequencies (0.03-2.0 Hz) and three amplitudes (2, 4, and 8°), corresponding to nine velocities (0.125-32°/s). The virtual floor oscillated from left to right (mediolateral) or from front to back (anteroposterior). We calculated the subjects' mean velocity (Ω) based on data from electromagnetic sensors positioned on the head and lower back. Our experiment shows that for temporal frequencies below 0.12 Hz, VIPR is visually dependent and increases with stimulus velocity. When stimulus velocity becomes too high, the body becomes incapable of following, and the VIPR saturates between 0.12 and 0.25 Hz. In this frequency range, maximal postural oscillation seems to depend on biomechanical constraints imposed by the positioning of the feet. For frequencies above 0.5 Hz, the body can no longer maintain the same oscillation state. This saturation may be linked to proprioceptive feedback mechanisms in the postural system.

[PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. / Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair).

BACKGROUND: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.