Diagnosis and management of complications following pelvic organ prolapse surgery using a synthetic mesh: French national guidelines for clinical practice.

Complications associated with pelvic organ prolapse (POP) surgery using a synthetic non-absorbable mesh are uncommon (<5%) but may be severe and may hugely diminish the quality of life of some women. In drawing up these multidisciplinary clinical practice recommendations, the French National Authority for Health (Haute Autorité de santé, HAS) conducted an exhaustive review of the literature concerning the diagnosis, prevention, and management of complications associated with POP surgery using a synthetic mesh. Each recommendation for practice was allocated a grade (A,B or C; or expert opinion (EO)), which depends on the level of evidence (clinical practice guidelines). PREOPERATIVE PATIENTS' INFORMATION: Each patient must be informed concerning the risks associated with POP surgery (EO). HEMORRHAGE, HEMATOMA: Vaginal infiltration using a vasoconstrictive solution is not recommended during POP surgery by the vaginal route (grade C). The placement of vaginal packing is not recommended following POP surgery by the vaginal route (grade C). During laparoscopic sacral colpopexy, when the promontory seems highly dangerous or when severe adhesions prevent access to the anterior vertebral ligament, alternative surgical techniques should be discussed per operatively, including colpopexy by lateral mesh laparoscopic suspension, uterosacral ligament suspension, open abdominal mesh surgery, or surgery by the vaginal route (EO). BLADDER INJURY: When a bladder injury is diagnosed, bladder repair by suturing is recommended, using a slow resorption suture thread, plus monitoring of the permeability of the ureters (before and after bladder repair) when the injury is located at the level of the trigone (EO). When a bladder injury is diagnosed, after bladder repair, a prosthetic mesh (polypropylene or polyester material) can be placed between the repaired bladder and the vagina, if the quality of the suturing is good. The recommended duration of bladder catheterization following bladder repair in this context of POP mesh surgery is from 5 to 10 days (EO). URETER INJURY: After ureteral repair, it is possible to continue sacral colpopexy and place the mesh if it is located away from the ureteral repair (EO). RECTAL INJURY: Regardless of the approach, when a rectal injury occurs, a posterior mesh should not be placed between the rectum and the vagina wall (EO). Concerning the anterior mesh, it is recommended to use a macroporous monofilament polypropylene mesh (EO). A polyester mesh is not recommended in this situation (EO). VAGINAL WALL INJURY: After vaginal wall repair, an anterior or a posterior microporous polypropylene mesh can be placed, if the quality of the repair is found to be satisfactory (EO). A polyester mesh should not be used after vaginal wall repair (EO). MESH INFECTION (ABSCESS, CELLULITIS, SPONDYLODISCITIS): Regardless of the surgical approach, intravenous antibiotic prophylaxis is recommended (aminopenicillin + beta-lactamase inhibitor: 30 min before skin incision +/- repeated after 2 h if surgery lasts longer) (EO). When spondylodiscitis is diagnosed following sacral colpopexy, treatment should be discussed by a multidisciplinary group, including especially spine specialists (rheumatologists, orthopedists, neurosurgeons) and infectious disease specialists (EO). When a pelvic abscess occurs following synthetic mesh sacral colpopexy, it is recommended to carry out complete mesh removal as soon as possible, combined with collection of intraoperative bacteriological samples, drainage of the collection and targeted antibiotic therapy (EO). Non-surgical conservative management with antibiotic therapy may be an option (EO) in certain conditions (absence of signs of sepsis, macroporous monofilament polypropylene type 1 mesh, prior microbiological documentation and multidisciplinary consultation for the choice of type and duration of antibiotic therapy), associated with close monitoring of the patient. BOWEL OCCLUSION RELATED TO NON-CLOSURE OF THE PERITONEUM: Peritoneal closure is recommended after placement of a synthetic mesh by the abdominal approach (EO). URINARY RETENTION: Preoperative urodynamics is recommended in women presenting with urinary symptoms (bladder outlet obstruction symptoms, overactive bladder syndrome or incontinence) (EO). It is recommended to remove the bladder catheter at the end of the procedure or within 48 h after POP surgery (grade B). Bladder emptying and post-void residual should be checked following POP surgery, before discharge (EO). When postoperative urine retention occurs after POP surgery, it is recommended to carry out indwelling catheterization and to prefer intermittent self-catheterization (EO). POSTOPERATIVE PAIN: Before POP surgery, the patient should be asked about risk factors for prolonged and chronic postoperative pain (pain sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Concerning the prevention of postoperative pain, it is recommended to carry out a pre-, per- and postoperative multimodal pain treatment (grade B). The use of ketamine intraoperatively is recommended for the prevention of chronic postoperative pelvic pain, especially for patients with risk factors (preoperative painful sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Postoperative prescription of opioids should be limited in quantity and duration (grade C). When acute neuropathic pain (sciatalgia or pudendal neuralgia) resistant to level I and II analgesics occurs following sacrospinous fixation, a reintervention is recommended for suspension suture removal (EO). When chronic postoperative pain occurs after POP surgery, it is recommended to systematically seek arguments in favor of neuropathic pain with the DN4 questionnaire (EO). When chronic postoperative pelvic pain occurs after POP surgery, central sensitization should be identified since it requires a consultation in a chronic pain department (EO). Concerning myofascial pain syndrome (clinical pain condition associated with increased muscle tension caused by myofascial trigger points), when chronic postoperative pain occurs after POP surgery, it is recommended to examine the levator ani, piriformis and obturator internus muscles, so as to identify trigger points on the pathway of the synthetic mesh (EO). Pelvic floor muscle training with muscle relaxation is recommended when myofascial pain syndrome is associated with chronic postoperative pain following POP surgery (EO). After failure of pelvic floor muscle training (3 months), it is recommended to discuss surgical removal of the synthetic mesh, during a multidisciplinary discussion group meeting (EO). Partial removal of synthetic mesh is indicated when a trigger point is located on the pathway of the mesh (EO). Total removal of synthetic mesh should be discussed during a multidisciplinary discussion group meeting when diffuse (no trigger point) chronic postoperative pain occurs following POP surgery, with or without central sensitization or neuropathic pain syndromes (EO). POSTOPERATIVE DYSPAREUNIA: When de novo postoperative dyspareunia occurs after POP surgery, surgical removal of the mesh should be discussed (EO). VAGINAL MESH EXPOSURE: To reduce the risk of vaginal mesh exposure, when hysterectomy is required during sacral colpopexy, subtotal hysterectomy is recommended (grade C). When asymptomatic vaginal macroporous monofilament polypropylene mesh exposure occurs, systematic imaging is not recommended. When vaginal polyester mesh exposure occurs, pelvic +/- lumbar MRI (EO) should be used to look for an abscess or spondylodiscitis, given the greater risk of infection associated with this type of material. When asymptomatic vaginal mesh exposure of less than 1 cm2 occurs in a woman with no sexual intercourse, the patient should be offered observation (no treatment) or local estrogen therapy (EO). However, if the patient wishes, partial excision of the mesh can be offered. When asymptomatic vaginal mesh exposure of more than 1 cm2 occurs or if the woman has sexual intercourse, or if it is a polyester prosthesis, partial mesh excision, either immediately or after local estrogen therapy, should be offered (EO). When symptomatic vaginal mesh exposure occurs, but without infectious complications, surgical removal of the exposed part of the mesh by the vaginal route is recommended (EO), and not systematic complete excision of the mesh. Following sacral colpopexy, complete removal of the mesh (by laparoscopy or laparotomy) is only required in the presence of an abscess or spondylodiscitis (EO). When vaginal mesh exposure recurs after a first reoperation, the patient should be treated by an experienced team specialized in this type of complication (EO). SUTURE THREAD VAGINAL EXPOSURE: For women presenting with vaginal exposure to non-absorbable suture thread following POP surgery with mesh reinforcement, the suture thread should be removed by the vaginal route (EO). Removal of the surrounding mesh is only recommended when vaginal mesh exposure or associated abscess is diagnosed. BLADDER AND URETERAL MESH EXPOSURE: When bladder mesh exposure occurs, removal of the exposed part of the mesh is recommended (grade B). Both alternatives (total or partial mesh removal) should be discussed with the patient and should be debated during a multidisciplinary discussion group meeting (EO).

Prevention of Rhesus-D Alloimmunization in the First Trimester of Pregnancy: Economic Analysis of Three Management Strategies.

Anti-D alloimmunization in the first trimester of pregnancy has long been the subject of prevention with anti-D immunoglobulins during events at risk of fetomaternal hemorrhage. Although the efficacy of preventing anti-D alloimmunization by an injection of immunoglobulin at 28 weeks of gestation (WG) is obvious, the literature provides little evidence of the effectiveness before 12+6 WG and several countries have modified their recommendations. In the presumed absence of a difference in alloimmunization risk between early and late prevention, our objective was to evaluate and compare the cost of treatment for 3 alloimmunization prevention strategies in France, the United Kingdom, and the Netherlands. This was a single-center retrospective study. Our target population included all women who received anti-D immunoglobulins (Rhophylac) in the first trimester of pregnancy before 12+6 WG at Nantes University Hospital in 2018 (N = 356). Within the target population, 2 other populations were constituted based on British (N = 145) and Dutch (N = 142) clinical practice guidelines (CPG). These 3 populations were analyzed for the comparative cost of treatment for prevention from a health system perspective. The average cost of Rhophylac alloimmunization prevention for 1 episode was €117.8 from a health system perspective. The total cost attributed to prevention in 2018 at Nantes University Hospital (N = 356) was €41,931.4 according to this perspective. If the UK CPG or Dutch CPG had been applied to the Nantes target population, a saving of around 60% would have been achieved. At the national level, the cost according to the health system perspective specifically attributable to induced abortion (N estimated = 26,916) could represent a total cost of €3,170,704. This study highlighted the high cost of the French prevention strategy in the first trimester of pregnancy compared with British or Dutch strategies. The modification of our practices would allow substantial financial savings to the French health system but would also avoid the nonrecommended exposure to a blood product at this term, would allow a faster medical management and a relief of the care system.

Evaluation Tools for Assessing Autonomy of Surgical Residents in the Operating Room and Factors Influencing Access to Autonomy: A Systematic Literature Review.

BACKGROUND: Surgical residents in France lack a clear pedagogical framework for achieving autonomy in the operating room. The progressive acquisition of surgical autonomy is a determining factor in the confidence of operators for their future independent practice. Currently, there is no autonomy scale commonly used in Europe. The objective of this study is to identify existing tools for quantifying the autonomy of residents and the factors that influence it. MATERIALS AND METHODS: We conducted a qualitative systematic review following the recommendations of the Systematic Review Without Meta-Analysis (SWiM) guidelines. Publications were extracted from the MEDLINE (PubMed), EMBASE, and PSYCINFO databases. All publications without date restrictions up to July 2022 were identified. RESULTS: Among the 231 identified publications, 21 met the inclusion criteria. Seventeen publications used a graded autonomy assessment tool by the student and/or the teacher, while 4 used evaluations by an observing third party. We found 8 different autonomy scales, with the Zwisch Scale representing 57.1% of the cases. Factors influencing autonomy were diverse, including the work context, experience, and gender of the resident and their teacher. DISCUSSION: We found heterogeneity in the tools used to "measure" the autonomy of a resident in the operating room. The SIMPL tool or the Zwisch Scale appear to be the most frequently used tools. The relationship between autonomy, performance, confidence, and knowledge may require multidimensional tools that encompass various areas of competence, but this could make their daily application more challenging. The factors influencing autonomy are numerous; and understanding them would improve teaching in the operating room. There is a significant lack of data on surgical autonomy in France, as well as a lack of evaluation in the field of gynecology-obstetrics worldwide.

Interstitial pregnancy management: A multicentric analysis of 98 patients from the FRANCOGENT group comparing surgery and medical treatment.

OBJECTIVE: To evaluate the outcomes associated with each therapeutic option for patients diagnosed with interstitial pregnancy (IP). METHODS: We conducted a multicentric retrospective cohort study within the departments of Gynecology and Obstetrics involved in the Francogent research group. Women treated for an interstitial pregnancy between January 2008 to December 2019 were included. Three therapeutic options were evaluated: surgical treatment (ST); in situ methotrexate combined with systemic methotrexate (IS-MTX); and systemic methotrexate (IM-MTX). Success of first-line treatment was defined by hCG negativation (<5I U/L). Secondary outcomes included the need for secondary surgical procedure, secondary medical treatment, emergency surgery, postoperative complications, duration of hospitalization, and delay before hCG negativation. RESULTS: A total of 98 patients were managed for IP: 42 (42.9%) patients had IM-MTX; 34 (34.7%) had IS-MTX; and 22 (22.4%) had ST. First-line treatment was successful in all patients of the ST group (22/22, 100%), in 31% of patients within the IM-MTX group (13/42) and 70.6% (24/34) in the IS-MTX group. The sole parameter associated with the risk of treatment failure was the mode of methotrexate administration. The size of the gestational sac or the presence of fetal heartbeat was not associated with decreased medical treatment (IS or IM-MTX) efficiency. CONCLUSION: Either ST or IS-MTX are good options for IP treatment associated with high success rates. A single-dose regimen of IM-MTX is less efficient than IS-MTX or ST. Symptomatic patients with severity criteria should always undergo emergency surgery. IP remains a high-risk condition that should be managed, whenever possible, in referral centers to potentialize the chances of favorable outcomes.

Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Evaluation of a scoring system for the detection of central sensitization among women with chronic pelvic pain.

BACKGROUND: Central sensitization is frequently associated with chronic pelvic pain and requires specific management. The pain is described as hypersensitivity to an innocuous stimulus that is both widespread and persistent. However, no study has evaluated if central sensitization can be measured objectively with neurophysiological tests in the pelvic and perineal area to prove this concept in women with chronic pelvic pain. OBJECTIVE: This study aimed to evaluate nociceptive thresholds (primary objective) and spatial and temporal diffusion of pain among women with chronic pelvic pain and high or low scores of central sensitization. STUDY DESIGN: This prospective, assessor-blinded, comparative study compared a cohort of women with chronic pelvic pain and a high (>5/10; n=29) vs low (<5/10; n=24) score of sensitization according to the Convergences PP criteria. Participants underwent a noninvasive bladder sensory test, a rectal barostat test, and a muscular (algometer) and a vulvar (vulvagesiometer) sensory test. Poststimulation pain (minutes), quality of life (Medical Outcomes Study 36-Item Short Form Survey), and psychological state, comprising anxiety (State-Trait Anxiety Inventory), depression (Beck Depression Inventory Short Form), and catastrophizing (Pain Catastrophizing Scale), were assessed. RESULTS: The participants mostly suffered from endometriosis (35.8%), irritable bowel syndrome (35.8%), bladder pain syndrome (32.1%), and vestibulodynia (28.3%). Baseline characteristics were similar. Women with a high sensitization score had more painful diseases diagnosed (2.7±1.3 vs 1.6±0.8; P=.002) and suffered for longer (11±8 vs 6±5 years; P=.028) than participants with a low score. The bladder maximum capacity was equivalent between participants (399±168 vs 465±164 mL; P=.18). However, the pain felt at each cystometric threshold was significantly increased in women with a high sensitization score. No difference was identified for the rectal pain pressure step (29.3±5.5 vs 30.7±6.5 mm Hg; P=.38). Rectal compliance was decreased in women with a high sensitization score with a considerable increase in pain felt. The average of pain pressure thresholds at the 5 vulvar sites tested was decreased in these participants (162.5±90.5 vs 358.7±196.5 g; P=.0003). Similar results were found for the average of the pain pressure thresholds at 6 muscles tested (1.34±0.41 vs 2.63±1.52 kg/m2; P=.0002). A longer period was needed for patients with high sensitization score to obtain a VAS <3 out of 10 after the stimulation of the bladder (4.52±5.26 vs 1.27±2.96 minutes; P=.01), the rectum (3.75±3.81 vs 1.19±1.23 minutes; P=.009), and the muscles (1.46±1.69 vs 0.64±0.40 minutes; P=.002). The psychological state was equivalent between groups. No association was found between the sensory thresholds and the psychological state results. The physical component of the quality of life score was reduced in women with high sensitization score (P=.0005), with no difference in the mental component. CONCLUSION: Using neurophysiological tests, this study showed that there are objective elements to assess for the presence of central sensitization, independently of psychological factors.

[Pelvic exam in gynecology and obstetrics: Guidelines for clinical practice]. / Examen pelvien en gynécologie et obstétrique : recommandations pour la pratique clinique.

OBJECTIVE: To provide guidelines for the pelvic clinical exam in gynecology and obstetrics. MATERIAL AND METHODS: A multidisciplinary experts consensus committee of 45 experts was formed, including representatives of patients' associations and users of the health system. The entire guidelines process was conducted independently of any funding. 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 committee studied 40 questions within 4 fields for symptomatic or asymptomatic women (emergency conditions, gynecological consultation, gynecological diseases, obstetrics, and pregnancy). 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 27 recommendations. Among the formalized recommendations, 17 present a strong agreement, 7 a weak agreement and 3 an expert consensus agreement. Thirteen questions resulted in an absence of recommendation due to lack of evidence in the literature. CONCLUSIONS: The need to perform clinical examination in gynecological and obstetrics patients was specified in 27 pre-defined situations based on scientific evidence. More research is required to investigate the benefit in other cases.

Robot-assisted laparoscopy repair of uterine isthmocele: A two-center observational study.

OBJECTIVE: To analyze outcomes and postoperative complications in patients undergoing robot-assisted isthmocele repair. METHOD: This retrospective cohort study included 33 patients who had robot-assisted laparoscopic surgical management of an isthmocele between September 2013 and August 2020 in two French university hospitals. All charts were reviewed to identify patient characteristics, preoperative and postoperative anatomical findings, complications, and postoperative fertility and symptoms. Patients who had undergone this procedure were asked to complete a telephone questionnaire about their treatment satisfaction and symptoms. RESULTS: The isthmocele was discovered most often as a result of subfertility (57.6%), but also ectopic pregnancy (18.2%), pelvic pain (15.2%), and postmenstrual bleeding (9.1%). Robot-assisted repair of the isthmocele significantly improved myometrial thickness (from 1.55 mm before surgery to 4.26 mm after surgery [mean difference 2.71; 95% confidence interval, 1.91-3.51], P = 0.0005). Among 20 patients who still desired a child after surgery, 15 became pregnant and 14 had full-term live births. Among the nine patients who had surgery for disabling symptoms, five had no persistent symptoms, three reported global improvement, and one had the same gynecologic discomfort. Seventeen patients agreed to complete the questionnaires (51.5%), and all stated that they would choose to have this surgery again. CONCLUSION: Robot-assisted repair of an isthmocele is a viable minimally invasive procedure.

Postpartum Depression after Maternal Isolation during the COVID-19 Pandemic: The MUMI-19 Study (Mothers Undergoing Mental Impact of COVID-19 Pandemic).

Background: The COVID-19 pandemic has shaken the world by imposing unprecedented health measures, including in the postpartum period. Objectives: We aim to assess the impact of maternal isolation in the immediate postpartum period on the rate of postpartum depression (PPD) in a tertiary center. Study Design: We conducted a prospective cohort study, between 22 April and 29 October 2020, using anonymous questionnaires on 265 participants (129 during lockdown and 135 outside). The Edinburgh Postnatal Depression Scale (EPDS) was used as screening for PPD. We used a univariate logistic regression model to analyze the association between risk factors and PPD. Results: There was no difference between the two groups for PPD assessed by an EPDS score >10.5 on day 30 and/or day 60 (23.1% vs. 29.3%, p = 0.661) but on day 3 it was higher (31% vs. 17.8%, p = 0.015) during the lockdown period and partners were more impacted psychologically (48.3% vs. 10.5%, p < 0.001). Parity ≥1 was a protective factor for PPD (OR = 0.2, 95% CI [0.1−0.6], p = 0.003). Risk factors of PPD were: history of psychological abuses (OR = 6.4, CI 95% [1.1−37.6], p = 0.04), stressful life event (OR = 4.5, CI 95% [1.6−12.6], p = 0.004), and bad birth experience (OR = 5.1, CI 95% [1.4−17.8], p = 0.012). Conclusion: Maternal isolation in the immediate postpartum period is associated with an increased rate of moderate to severe symptoms of postpartum blues. The well-known long-term consequences of PPD must be balanced against the expected benefits of partner's restrictive access to maternity ward.

Ropivacaine perineal infiltration for postpartum pain management in episiotomy repair: a double-blind, randomised, placebo-controlled trial.

OBJECTIVE: To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo. DESIGN: Two-centre, double-blind, randomised, controlled trial. SETTING: Two French maternity units, October 2017 to April 2020. POPULATION: 272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair. METHODS: Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months). MAIN OUTCOME MEASURES: The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI). RESULTS: Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life. CONCLUSIONS: This study did not demonstrate any benefit of ropivacaine infiltration over placebo.

Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study).

BACKGROUND: Miscarriage is a frequent problem that requires dilation and curettage in 30% of cases. This routine surgery may lead to intrauterine adhesions and severe infertility. Hyaluronic acid gel is known to reduce intrauterine adhesions after hysteroscopic surgery. OBJECTIVE: This study aimed to evaluate the rate of intrauterine adhesions after dilation and curettage for miscarriage with and without hyaluronic acid gel. STUDY DESIGN: This was a multicentric (9 hospitals in France), prospective, open-label randomized trial. Patients who had a miscarriage between weeks 7 and 14 of gestation, required dilation and curettage, and wanted another pregnancy were eligible for the study. Women were randomly assigned in a 1:1 ratio to surgery alone (control group) or surgery with intrauterine instillation of hyaluronic acid gel (gel group). An office hysteroscopy was planned at 6 to 8 weeks after surgery. The primary endpoint was the rate of intrauterine adhesions during this office follow-up hysteroscopy. Two different follow-up fertility surveys were sent at 6 months and 1 year after the end of the intervention, respectively. RESULTS: Among the 343 patients who had curettage, 278 had hysteroscopy. After multiple imputation, the rate of intrauterine adhesions was lower in the gel group than in the control group (9.1% vs 18.4%, respectively; P=.0171). Among the 110 responders to the surveys, the overall pregnancy rate at 12 months after surgery was 64.5% (71/110), and similar in both groups (57.4% [27/47] in the control group vs 69.8% [44/63] in the gel group; P=.1789). CONCLUSION: Intrauterine instillation of hyaluronic acid gel reduces the rate of intrauterine adhesions in women treated with dilation and curettage for miscarriage.

Vaginal delivery of the second twin: A simulation program for residents in obstetrics and gynecology in a type III university maternity hospital.

OBJECTIVE: To implement a vaginal delivery of the second twin simulation program for obstetric and gynecology residents, to reduce maternal-fetal mortality in the management of twin pregnancies in the delivery room. DESIGN: A prospective education program. The session consisted of a theoretical part, a practical part on a mannequin and an evaluation. The model was designed in a simple and reproducible way. The simulation evaluation was done at several levels according to the validated Kirkpatrick model. SETTING: A tertiary level university maternity hospital. PARTICIPANTS: Ten obstetric and gynecology residents participated. RESULTS: The resident's personal feelings about their ability to perform the maneuvers increased significantly after participation in the simulation session. Their technical skills in performing the maneuvers were assessed in a second step. The majority of the participants considered the model realistic and the session useful. All agreed that the simulation was an essential part of their learning process. CONCLUSION: A simulated vaginal delivery of the second twin session allows residents to be safely trained in these obstetrical maneuvers, which can be difficult to teach and perform.

Local injection of methotrexate ultrasound guided-transvaginal.

Non-tubal ectopic pregnancies can be located in the uterine portion of the tube (interstitial or cornual), in the cervix (cervical), in a cesarian scar, in the ovary, or intra-abdominally. Even though they are rare, they are associated with a high mortality. Invasive surgeries such as cornuectomy and hysterectomy were common to treat them in case of hemorrhage. Thanks to recent advances in imaging techniques, diagnosis of non-tubal ectopic pregnancy is made earlier and conservative management has been developed in order to respect fertility of patients. Beyond these treatments, systemic or local injection of Methotrexate shows very good success. In the article, we aimed to describe the technics of vaginal injection of in situ methotrexate with ultrasound guidance.

Technical notes surgical treatment of a ruptured interstitial pregnancy.

Non-tubal ectopic pregnancies represent fewer than 10% of all ectopic pregnancies. However, they are associated with a high rate of mortality due to late diagnosis and uterine horn rupture which requires radical emergency surgical management. Cornuectomy via laparoscopy is a treatment of choice. We provide here a simple description of laparoscopic cornuectomy using an Endo GIA stapling system: the Endo GIA® automatic forceps. It has the advantage of removing the mass, suturing, and achieving satisfactory haemostasis in a single step.

Impact of uterine fibroid surgery on lower urinary tract symptoms.

OBJECTIVE: Uterine fibroids are often associated with lower urinary tract symptoms (LUTS), the exact prevalence of which has been underexplored. Our main objective was to evaluate the effect of surgical treatment of fibroids on LUTS. Our secondary objectives were to assess the prevalence of LUTS in women undergoing fibroid surgery and to analyze the relationship between the characteristics of fibroids and the severity of symptoms. METHODS: This was a prospective study of women conducted between 2019 and 2021. The main endpoint was the change in the total UDI-6, IIQ7, ICIQ-SF and CONTILIFE scores preoperatively and 6 weeks postoperatively. RESULTS: Of the 55 included women, 63.6% had frequency and 60% had urgency. Six weeks postoperatively, urinary symptoms had significantly improved for all scores. The presence of an anterior fibroid was significantly associated with higher urinary symptom scores for the UDI-6 (p = 0.007) and ICIQ-SF scores (p = 0.04). The size of the uterus or dominant fibroid was not significantly associated with the severity of urinary symptoms. CONCLUSION: Fibroids are often associated with symptoms of overactive bladder. An anterior location of the fibroid appears to be associated with greater severity scores. Surgical treatment appears to reduce urinary symptoms 6 weeks postoperatively.

Management of non-tubal ectopic pregnancies in France: Results of a practice survey.

INTRODUCTION: Non-tubal ectopic pregnancies (NTEP) in France constitute approximately 5% of ectopic pregnancies (EP). A NTEP can be abdominal, ovarian, cervical, interstitial, on a caesarean scar, or cornual. These pregnancies, which are sometimes difficult to diagnose and are often diagnosed late, carry a high risk of complications, particularly haemorrhages. Many treatments have been described for treating these NTEP. Our objective is to assess how they are cared for in terms of diagnosis, treatment and monitoring. EQUIPMENT AND METHODOLOGY: An online questionnaire was sent out to all members of the French Society of gynecologic and Pelvic Surgery (SCGP) in September 2020. The questionnaire was in the form of two clinical cases on interstitial and caesarean scar pregnancies. RESULTS: 141 SCGP members responded (36%). For diagnosis, 58% of respondents enlisted the help of a specialist sonographer. MRI is rarely used for diagnosis to the extent that it was only requested in 7% of cases for interstitial pregnancy and 23.6% of cases for caesarean scar pregnancy. In the case of stable interstitial pregnancy without signs of complications, treatment is predominantly medical (90%), with the use of methotrexate (MTX) by intramuscular injection in 33.3% of cases, by in situ injection in 30.7% of cases, or a combination of the two in 36% of cases. If there were signs of pre-rupture, the majority of respondents performed laparoscopic surgical treatment (79.3%). In terms of caesarean scar pregnancies, the treatment was predominantly medical (78.2%) with the use of MTX only, as an intramuscular injection in 23.3% of cases, in situ in 36% of cases, and as a combination of intramuscular and in situ in 37.2% of cases. DISCUSSION: Non-tubal ectopic pregnancies are sometimes difficult to diagnose in the first trimester and constitute a significant haemorrhage risk for patients. In France, there is currently no specific recommendation on this subject and there is huge disparity in practice.

How is functionning the Ethical Review Board « Comité d'Ethique Pour La Recherche En Obstétrique Et Gynécologie ¼ (CEROG) ?

INTRODUCTION: The French College of Gynecology and Obstetrics (CNGOF) has created an Ethical Review Board called the CEROG that aim to ensure the research projects are in conformity with the regulation and the laws, as well as to allow their publication in international scientific journals. The aim of this work was to analyze the work of this committee through the application received and to review the ethical procedures required by type of research project. METHODS: We conducted a national retrospective study of all applications from 2018 to 2021 received by the CEROG Ethical Review Board. Each application must contain a verification of conformity with the MR004 regulation, a submission form and an information form to the patients involved. At reception, the documents are anonymized and then addressed to the members of one of the two independent sections (Obstetric and Prenatal diagnosis or Gynecology and Assisted Reproductive Therapy). RESULTS: Two hundred and sixty applications were received, including 52% in the Gynecology section and 48% in the Obstetrics' section. Only 10% (14/136) and 8% (10/124) were disapproved, respectively. In total, 35% of the applications to the Gynecology section leaded to publications in scientific journals but only 23% did so in the Obstetrics section. Most publications (60.8%) were in low impact factors journals (rank D and E). CONCLUSION: The Ethical Review Board CEROG is essential to ensure the conformity of the research projects with French regulations and allow fast publication in international journals.

Efficacy of In Situ Methotrexate Injection in the Treatment of Nontubal Ectopic Pregnancies: A Retrospective Multicenter Study.

STUDY OBJECTIVE: Evaluation of the efficacy of different injection sites of methotrexate in the treatment of nontubal ectopic pregnancies. DESIGN: Retrospective multicenter study. SETTING: Multicenter, including 3 teaching hospitals, an intercommunal hospital, and a clinic. PATIENTS: A total of 106 patients with nontubal ectopic pregnancies, including 59 interstitial, 39 cesarean scar, and 8 cervical or isthmic. INTERVENTIONS: Overall, 58 patients received methotrexate via intramuscular injection (IM group), 35 received methotrexate via in situ injection (IS group), and 13 received a combination of both in situ and intramuscular injections of methotrexate (IS + IM group). MEASUREMENTS AND MAIN RESULTS: The main end point of this study was measured via the primary success rate (defined as a negative ß-human chorionic gonadotropin level without recourse to any additional treatment) of treatment with methotrexate according to injection site. The primary success rate was 46.55% in the IM group, 60% in the IS group, and 61.54% in the IS + IM group, respectively. In the multivariate analysis, the primary success rate of treatment was significantly correlated to the in situ injection of methotrexate, either solely or in conjunction with an intramuscular injection of methotrexate administered the following day, (odds ratio = 2.7; 95% confidence interval, 1.03-7.14). CONCLUSION: Solely an intramuscular injection of methotrexate is a less efficient first-line treatment strategy for the conservative management of nontubular ectopic pregnancy. The use of an in situ injection of methotrexate should therefore be preferred.

Management of external cephalic version in France: A national practice survey.

INTRODUCTION: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020. OBJECTIVE: To evaluate the national practices of ECV in French maternity units, especially on the use of tocolysis, 1 year after publication of the French clinical recommendations guidelines by the French national college of obstetricians and gynecologists (CNGOF). METHODS: Data self-reported for this national descriptive study were collected from March to May 2021 by an online questionnaire distributed to all French maternities. The 25 items of the questionnaire collected information of maternity units, the general practice of ECV, use or not of tocolysis for ECV attempt and the relevance of a prospective study. RESULTS: Of the 517 French maternity units, 150 (29%) responded to the online survey.  95,3% systematically performed ECV. A Kleihauer test was routinely performed in 71 units (49.7%). A tocolysis was associated with ECV attempt in 52.4% of cases. The drugs used were intravenous atosiban (30,7%), mainly in levels 2b and 3 maternity units, intravenous salbutamol (24%), other mode of administration of salbutamol (14,7%) and oral nifedipine (22,6%) mainly in levels 1 and 2a maternity units. Adverse effects were described in 20%, mainly with the use of salbutamol (73,3%). CONCLUSIONS: 52.4% of the French maternity units surveyed used tocolysis for the ECV attempt, although it is systematically recommended. The choice of tocolytic drug differed according to the maternity units.