Interdisciplinary Simulation Courses to Train Residents on Communication of Unexpected Complications from Perioperative Care: A Randomized Comparison of Within-Event (Microdebriefing) and Postscenario Debriefing.

INTRODUCTION: Training to disclose bad news in a pluridisciplinary format facilitates communication and improves learning. There are many different debriefing methods described in the literature. The aim of this study was to compare and evaluate the value of final debriefing and microdebriefing with interruptions of the scenario in a simulation program about communication in unexpected complications from perioperative care. METHODS: We conducted a prospective, randomized, single center study between October 2018 and July 2019 in a simulation center. Three scenarios were related to patient or family disclosure of complications which had occurred during gynecologic surgery by a dyad involving 2 residents (a gynecology and an anesthesia resident). All sessions involved 6 residents (3 gynecologist and 3 anesthesiologist). The main outcome measure was the immediate residents' self-assessment of the impact of the course on their medical practice immediately after the session. RESULTS: We performed 15 simulation sessions including 80 residents. Thirty-nine residents were included in final debriefing group and 41 in micro-debriefing group. There was no significant difference on the impact for medical practice between groups (9.3/10 in the micro-debriefing group versus 9.2 in the final debriefing group (p = 0.53)). The overall satisfaction was high in the 2 group (9.1/10 in the 2 groups). CONCLUSION: This study is the first one to compare two debriefing methods in case of breaking bad news simulation. No difference between the 2 techniques was found concerning the students' feelings and short and long-term improvement of their communication skills.

Diagnostic accuracy validation study of the M6 model without initial serum progesterone (M6NP) in triage of pregnancy of unknown location.

OBJECTIVES: The M6 prediction model stratifies the risk of development of ectopic pregnancy (EP) for women with pregnancy of unknown location (PUL) into low risk or high risk, using human chorionic gonadotrophin (hCG) and progesterone levels at the initial visit to a gynaecological emergency room and hCG level at 48 h. This study evaluated a second model, the M6NP model, which does not include the progesterone level at the initial visit. The main aim of this study was to validate the diagnostic accuracy of the M6NP model in a population of French women. STUDY DESIGN: Between January and December 2021, all women with an hCG measurement from the gynaecological emergency department of a teaching hospital were screened for inclusion in this study. Women with a pregnancy location determined before or at the second visit were excluded. The diagnostic test was based on logistic regression of the M6NP model, with classification into two groups: high risk of EP (≥5%) and low risk of EP (<5%). The reference test was the final outcome based on clinical, biological and sonographic results: failed PUL (FPUL), intrauterine pregnancy (IUP) or EP. Diagnostic performance for risk prediction of EP, and also IUP and FPUL, was calculated. RESULTS: In total, 759 women with possible PUL were identified. After screening, 341 women with PUL were included in the main analysis. Of these, 186 (54.5%) were classified as low risk, including three (1.6%) with a final outcome of EP. The remaining 155 women with PUL were classified as high risk, of whom 60 (38.7%), 66 (42.8%) and 29 (18.7%) had a final outcome of FPUL, IUP and EP, respectively. Of the 32 women with PUL with a final outcome of EP, 29 (90.6%) were classified as high risk and three (9.4%) were classified as low risk. Therefore, the performance of the M6NP model to predict EP had a negative predictive value of 98.4%, a positive predictive value of 18.7%, sensitivity of 90.6% and specificity of 59.2%. If the prediction model had been used, it is estimated that 4.5 visits per patient could have been prevented. CONCLUSION: The M6NP model could be used safely in the French population for risk stratification of PUL. Its use in clinical practice should result in a substantial reduction in the number of visits to a gynaecological emergency room.

Gender awareness among general practitioners in France: a cross sectional study using the Nijmegen Gender Awareness in Medicine Scale (N-GAMS).

Gender is a key determinant of health and healthcare use. The question of whether physicians are aware of gender issues is important to avoid gender bias in medical practice. This study aimed to validate the Nijmegen Gender Awareness in Medicine Scale (N-GAMS) in a representative population of French general practitioners (GPs) and to analyze their gender sensitivity and the presence of gender stereotypes among them. The N-GAMS, already validated in medical students, measures gender awareness through 3 subscores: gender sensitivity (GS) and gender-role ideology towards patients (GRIP) and doctors (GRID) (gender stereotypes). After translation into French, it was distributed to 900 GPs. The scale was validated through exploratory factor analysis (EFA). Psychometric properties were tested. Multivariate linear regressions were conducted to explore the associations between GPs' characteristics and N-GAMS subscores. EFA identified 3 meaningful factors consistent with prior theory. Subscores exhibited good internal consistency. The main findings were that GRIP was significantly higher in older physicians, in male physicians, among those who less involved their patients in decisions, and those who were not training supervisors. For GRID, results were quite similar to those of GRIP. GS was significantly higher for physicians working in health centres or medical homes and for those with gynecological practices but lower when they less involved patients in medical decisions. This study suggests that it is necessary to teach gender issues not only in medical schools but also as part of continuing medical education.

Women's preferences for less active ectopic pregnancy treatment: A discrete choice experiment.

RESEARCH QUESTION: Shared decision-making has become a hallmark of quality care and is increasingly spotlighted in practice guidelines. Little is known about women's views for treatment of less active ectopic pregnancy. What are the preferences of women for less active ectopic pregnancy treatment-related attributes? DESIGN: A discrete choice model with 8 attributes depicting ectopic pregnancy treatment including varying levels of first-line treatment effectiveness, length of hospitalization, cost, length of sick leave, of convalescence, need for surgical management, for emergency care during convalescence and for tube removal was used. Childbearing aged women, i.e. those who might experience an ectopic pregnancy in the future, were recruited. They were asked to choose between hypothetical treatments in 18 choice tasks with different levels of all treatment attributes. A conditional logit McFadden's choice model was performed. The main outcome measure was preference weights for less active ectopic pregnancy treatment-related attributes. RESULTS: A total of 5770 observations from 178 women were analysed. The attributes displaying the highest marginal impacts on women's decisions included: higher rate of first-line treatment effectiveness, lower rate of tube removal, lower rate of surgical management, shorter length of hospitalization and, to a lesser extent, but still significant, shorter length of convalescence, absence of risk of emergency care during convalescence and lower cost. CONCLUSIONS: Trade-offs made by women between the attributes of less active ectopic pregnancy treatment suggest that no treatment option, either medical or surgical, is an obvious preferred option. These results encourage the promotion of shared decision-making.

Indigo carmine dye for detecting urinary track damage during vaginal surgery.

OBJECTIVE: Unrecognized ureteral and bladder injury increase morbidity and mortality in gynecologic surgery. The primary objective of this study is to analyze the efficiency of a systematic intra-venous (IV) injection of carmine indigo to detect bladder injury in gynecologic vaginal surgery for benign disease. The secondary objective is to analyze the cost and use of carmine indigo. STUDY DESIGN: A retrospective, monocentric study was conducted in a tertiary hospital between January 2018 and October 2021. All patients undergoing a vaginal surgery of hysterectomy for benign disease or anterior prolapse were systematically included. Patients can be systematically included by the automatic coding of surgery. After anesthesia, during the patient's installation, an intravenous injection of 5 mL of intravenous indigo carmine (Carmyne®) diluted in 100 mL of physiological serum was systematically administered by the anesthesia team. Intraoperative cystoscopy was performed only in cases of suspected associated ureteral injury. RESULTS: We recorded 443 vaginal hysterectomies for benign disease and 95 vaginal anterior prolapse surgeries. There were 6 (1,4%) bladder injuries during vaginal hysterectomies and 1 (1,1%) bladder injury during vaginal prolapse surgery. All bladder injuries were diagnosed intraoperatively. No ureteral injury was diagnosed in this series of patients. No complication related to IV indigo carmine injection was found. In this tertiary hospital, 1085 ampoules of carmine indigo were ordered during the same period, approximatively 270 per year. The total cost to the gynecology and obstetrics department was 19,600 euros, or about 4,900 euros per year. Half of the carmine indigo was used in vaginal surgery and half in laparotomy, caesarean section and endometriosis surgery for suspected bladder or ureteral injury.

Are breast cancer patients with suboptimal adherence to cardiovascular treatment more likely to discontinue adjuvant endocrine therapy? Competing risk survival analysis in a nationwide cohort of postmenopausal women.

BACKGROUND: High rates of discontinuation undermine the effectiveness of adjuvant endocrine therapy (AET) among hormone-receptive breast cancer patients. Patient prognosis also relies on the successful management of cardiovascular risk, which affects a high proportion of postmenopausal women. As with AET, adherence with cardiovascular drugs is suboptimal. We examined whether patient adherence with cardiovascular drugs was associated with the rate of AET discontinuation in a French nationwide claims database linked with hospitalisation data. METHODS: We identified postmenopausal women starting AET between 01/01/2016 and 31/12/2020 and taking at least two drugs for the primary prevention of cardiovascular disease (antihypertensive drugs, lipid-lowering drugs and platelet aggregation inhibitors) before AET initiation. Adherence was assessed for each drug class by computing the proportion of days covered. Women were categorised as fully adherent, partially adherent or fully non-adherent with their cardiovascular drug regimen based on whether they adhered with all, part or none of their drugs. AET discontinuation was defined as a 90-day gap in AET availability. Time to AET discontinuation according to levels of cardiovascular drug adherence was estimated using cumulative incidence curves, accounting for the competing risks of death and cancer recurrence. Multivariate cause-specific Cox regressions and Fine-and-Gray regressions were used to assess the relative hazards of AET discontinuation. RESULTS: In total, 32,075 women fit the inclusion criteria. Women who were fully adherent with their cardiovascular drugs had the lowest cumulative incidence of AET discontinuation at any point over the 5-year follow-up period. At 5 years, 40.2% of fully non-adherent women had discontinued AET compared with 33.5% of partially adherent women and 28.8% of fully adherent women. Both partial adherence and full non-adherence with cardiovascular drugs were predictors of AET discontinuation in the two models (cause-specific hazard ratios 1.16 [95% CI 1.10-1.22] and 1.49 [95% CI 1.39-1.58]; subdistribution hazard ratios 1.15 [95% CI 1.10-1.21] and 1.47 [95% CI 1.38-1.57]). CONCLUSION: Clinicians should be aware that patients who do not adhere with their entire cardiovascular drug regimen are also more likely to discontinue AET. This stresses the importance of integrated care, as suboptimal adherence with both treatment components poses a threat to achieving ideal patient outcomes.

Correlation between clinical examination and perineal ultrasound in women treated for pelvic organ prolapse.

INTRODUCTION: Lifetime risk of surgery for female pelvic organ prolapse (FPOP) is estimated at 10 to 20%. Prolapse assessment is mostly done by clinical examination. Perineal ultrasound is easily available and performed to evaluate and stage FPOP. This study's aim is to evaluate the agreement between clinical examination by POP-Q and perineal sonography in women presenting pelvic organ prolapse. MATERIALS AND METHODS: We carried out a prospective study from December 2015 to March 2018 in the gynecologic department of a teaching hospital. Consecutive woman requiring a surgery for pelvic organ prolapse were included. All women underwent clinical examination by POP-Q, perineal ultrasound with measurements of each compartment descent, levator hiatus area and posterior perineal angle. They also answered several functional questionnaires (PFDI 20, PFIQ7, EQ-5D and PISQ12) before and after surgery. Data for clinical and sonographic assessments were compared with Spearman's test and correlation with functional questionnaires was tested. RESULTS: 82 women were included. We found no significant agreement between POP-Q and sonographic measures of bladder prolapse, surface of the perineal hiatus or perineal posterior angle. There was a significant improvement of most of the functional scores after surgery. DISCUSSION: Our study does not suggest correlation between clinical POP-Q and sonographic assessment of bladder prolapse, hiatus surface or perineal posterior angle. Ultrasound datasets were limited by an important number of missing data resulting in a lack of power.

Diagnostic accuracy study of sonography in adenomyosis: A study of current practice.

OBJECTIVES: To estimate diagnostic accuracy of sonography in the diagnosis of adenomyosis in current practice when compared to pathology as a "gold standard". METHODS: This diagnosis accuracy study was observational and retrospective, including women managed by hysterectomy for benign pathology from January 2015 to November 2018. Preoperative pelvic sonography reports were collected, including details on diagnosis criteria for adenomyosis. Sonographic findings were compared to pathological results of the hysterectomy specimens. RESULTS: Our study initially concerned 510 women; 242 of them had adenomyosis confirmed by a pathological examination. The pathological prevalence of adenomyosis was 47.4% in this study. A preoperative sonography was available for 89.4% of the 242 women, with a suspicion of adenomyosis in 32.7% of them. In this study, Sensitivity is 52%, Specificity 85%, Positive Predictive Value (PPV) 77%, Negative Predictive Value (NPV) 86% and Accuracy 38,1%. CONCLUSIONS: Pelvic sonography is the most common non-invasive examination used in gynecology. It is also the first recommended examination for the diagnosis of adenomyosis because of its acceptability and its cost, even if the diagnosis performances are moderate. However, these performances are comparable to MRI (Magnetic Resonance Imaging) performances. The use of a standardized sonographic classification could improve and harmonize the diagnosis of adenomyosis.

Asherman Syndrome after Uterine Artery Embolization: A Cohort Study about Surgery Management and Fertility Outcomes.

STUDY OBJECTIVE: To study the severity of intrauterine adhesions (IUA) after uterine arterial embolization and to evaluate fertility, pregnancy, and obstetrical outcomes after hysteroscopic treatment. DESIGN: Retrospective cohort. SETTING: French University Hospital. PATIENTS: Thirty-three patients under the age of 40 years who were treated by uterine artery embolization with nonabsorbable microparticles between 2010 and 2020 for symptomatic fibroids or adenomyosis, or postpartum hemorrhage. INTERVENTIONS: All patients had a diagnosis of IUA after embolization. All patients desired future fertility. IUA was treated with operative hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Severity of IUA, number of operative hysteroscopies performed to obtain a normal cavity shape, pregnancy rate, and obstetrical outcomes. Of our 33 patients, 81.8% had severe IUA (state IV et V according to the European Society of Gynecological Endoscopy or state III according to the American fertility society classification). To restore fertility potential, an average of 3.4 operative hysteroscopies had to be performed [CI 95% (2.56-4.16)]. We reported a very low rate of pregnancy (8/33, 24%). Obstetrical outcomes reported are 50% of premature birth and 62.5% of delivery hemorrhage partly due to 37.5% of placenta accreta. We also reported 2 neonatal deaths. CONCLUSION: IUA after uterine embolization is severe, and more difficult to treat than other synechiae, probably related to endometrial necrosis. Pregnancy and obstetrical outcomes have shown a low pregnancy rate, an increased risk of preterm delivery, a high risk of placental disorders, and very severe postpartum hemorrhage. Those results have to alert gynecologists and radiologists to the use of uterine arterial embolization in women who desire future fertility.

A core outcome set for future research in ectopic pregnancy: an international consensus development study.

OBJECTIVE: To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP). DESIGN: To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible. SETTING: Not applicable. PATIENT(S): Health care professionals, researchers, and individuals with lived experience in EP. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Consensus for inclusion in core outcome set. RESULT(S): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction. CONCLUSION(S): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care.

Do Surgeons Anticipate Women's Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial.

Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.

Innovations in surgery to perform an ovarian drilling.

BACKGROUND: Ovarian drilling is a surgical technique for patients with dysovulatory polycystic ovarian syndrome. It is proposed as a second-line treatment in case of failure of medical treatment with Clomiphene citrate, Metformin or Letrozole. The 2020 Cochrane study comparing gonadotrophin stimulation and drilling has found the same pregnancy rate in both cases. The literature review concludes that 50% of spontaneous ovulation occurs in the first three months after drilling and 80% of pregnancy occurs in the following year. Ovarian drilling has also an impact on androgen excess and metabolic syndrome. AIMS: To update on the different surgical techniques to perform an ovarian drilling: surgical approach, energy used, operative risks. TECHNIQUES: The objective of an ovarian drilling is to destroy 5% of the ovarian stroma. It is recommended to perform 8 to 10 perforations in each ovary with bipolar energy. Laser C02 and monopolar energy can be used but increase the risk of adhesion. The surgical approach is actually laparoscopic. Abdominal laparoscopy or transvaginal laparoscopy by vNOTES can be performed. The advantage of the second one is to provide an easier access to the pelvic cavity in case of obesity and patient have no abdominal scare. Both laparoscopic approaches allow an evaluation of tubal patency and adhesiolysis or fimbrioplasty. That it's not the case of an alternative technique: the fertiloscopy, due to coaxial instrumentation in spite of less rate of post-operative adhesions. Operative risks are abdominal adhesions, damage to neighboring organs and due to the general anesthesia. CONCLUSION: Different surgical techniques exist to perform an ovarian drilling. The surgeon can choose the one that he masters best and that will involve the least risk for the patient. It is recommended to use bipolar energy.

Adhesions in abdomino-pelvic surgeries: A real economic impact?

STUDY OBJECTIVE: To evaluate the epidemiologic and economic burden related to adhesions and their complications for the French healthcare system. DESIGN: A descriptive and economic retrospective analysis. SETTING: Medicalized information system program (PMSI), national scale of costs. PATIENTS: Female patients operated on to treat adhesions related complications in 2019. INTERVENTIONS: All patients with coded adhesiolysis acts were selected in order to identify the characteristics of Diagnosis related groups (DRG) and compare them with the general DRGs. Then, a sub-analysis on surgery types (laparoscopy or open procedures) was performed to evaluate impact adhesions development and Length of Stay. Lastly, direct costs of adhesions for the healthcare system were quantified based upon adhesiolysis acts coded as main diagnosis. MEASUREMENTS AND MAIN RESULTS: 26.387 adhesiolysis procedures were listed in France in 2019 through 8 adhesiolysis acts regrouping open surgeries and laparoscopic procedures. Adhesiolysis was coded in up to 34% in some DRGs for laparoscopic procedures. 1551 (1461 studied in our study) surgeries have been realized in 2019 with main procedure: adhesiolysis. These surgeries were associated with an expense of €4 million for the healthcare system for rehospitalizations and reoperations only. Social costs such as sick leaves, drugs and other cares haven't been taken in consideration. CONCLUSION: Adhesions related complications represent a massive burden for patients and an expensive problem for society. These difficulties may likely to be reduced by a broader use of antiadhesion barriers, at least in some targeted procedures.

Concomitant vesicovaginal fistula and rectovaginal fistula in a patient with a neglected pessary placed for pelvic organ prolapse.

INTRODUCTION: Pelvic organ prolapse is a very frequent affection especially in elderly women. Vaginal pessary is a common conservative treatment and recommended as first line therapy. Guidelines recommend to do a regular follow up every 6 to 12 months with a healthcare professional. We report the case of a patient with neglected vaginal pessary who had a vesicovaginal and a concomitant rectovaginal fistula. CASE REPORT: A 84-year-old woman was admitted for chronic pelvic pain and vaginal discharge. An entrapped cube pessary was removed and the diagnostic of a 3cm rectovaginal fistula with a vesicovaginal fistula was made. The patient had a two-stage surgery, vaginal way then open abdominal way, for closing the fistulas. CONCLUSION: Although vaginal pessary is a good conservative treatment for POP, it shall not be neglected or serious complications can be caused.

Evaluation of the impact of body mass index < 18,5 kg/m2 in early pregnancy on obstetric and neonatal outcomes.

OBJECTIVES: In France, 7% of women have a BMI under 18,5 kg/m2 in early pregnancy. Adverse pregnancy outcomes associated with underweight are rarely described in French literature. This study evaluates obstetric and neonatal outcomes of underweight women compared with women with a normal BMI. METHODS: We conducted a retrospective monocentric study within University hospital of Bicetre. This study included 285 women with singleton pregnancy and a BMI <18.5 kg /m2 who gave birth after 15 weeks of gestation between January 2017 and February 2019. Their socio-demographic characteristics, obstetrical complications, neonatal and postpartum outcomes were compared with those of 285 women with normal BMI. RESULTS: The underweight women are more socially vulnerable and have a significantly higher risk of anemia (p = 0,045) and having small for gestational age infants (p < 0,01). There was no significant difference regarding the mode of delivery and in the early health status of the newborns. Inadequate pregnancy weight gain appeared to be an independent risk factor of low birth weight. CONCLUSION: Our study suggests that a lower-than-normal BMI in early pregnancy is associated with more social difficulties and exposes women to specific morbidity. This is an important element in the initial assessment of obstetrical risk, which justifies an adapted pregnancy follow-up.

Emergencies in gynecological surgery: Feasibility of delayed day- care surgery management.

OBJECTIVE: Hospital-day-care surgery is currently a priority for the healthcare system and is booming due to its' favorable financial impact. In gynecology, the management of surgical interventions for patients who've come to the Hospital Emergency Department, could in a number of cases, be delayed for a few h or several days. It would be it possible to organize a specific hospital day-care management program for the delayed surgeries. The aim of the study is to evaluate the feasibility of hospital day-care management of delayed gynecological emergencies. METHODS: This is a prospective, observational, unicentric study performed in the gynecological department of a teaching hospital from January 2016 through March 2017. Women having gynecological emergencies requiring surgical management were included in this study. The leading causes for surgical management and thus for inclusion in this study were nonviable pregnancies or retained products of conception, vulvar or breast abscesses, ectopic pregnancies and complications of ovarian cysts. For women with emergencies that could be delayed, surgery was scheduled between 12 h and 12 days after a woman's initial emergency examination at the hospital. Postoperative consultation was at the emergency department or completed by the referring physician. Re-hospitalization and re-intervention rates were collected 6 to 8 weeks after the initial emergency management. RESULTS: Three hundred and forty-eight women requiring surgical management consulted for gynecological emergencies over the period of the study. One hundred and eighty-one (52%) were managed in delayed day-care. The rate of surgical emergency management between the initial emergency consultation and the delayed day-care surgery was 1.8%. The consultation rate of a return to the emergency department prior to the planned delayed day-care was 12.2% (21/171). The rate of unplanned re-admissions in the month following surgery was 1.8% (3/171). The overall Satisfaction rate was high (170/171 99.4%). CONCLUSION: The delayed surgical management of gynecological emergencies thus seems feasible and beneficial for both women and the healthcare system. An economic evaluation could be performed to evaluate the lower costs/savings for delayed day-care management of gynecological emergencies.

vNOTES for Ovarian Drilling: A New Minimal Invasive Technique.

STUDY OBJECTIVE: To show a new mini-invasive surgical technique of ovarian drilling and fertility workup using transvaginal natural orifice transluminal endoscopic surgery (vNOTES). DESIGN: Stepwise demonstration of the technique with narrated video footage. SETTING: Ovarian drilling is a surgical technique for patients with dysovulatory polycystic ovary syndrome. The aim of this technique is to destroy 5% to 10% of the ovarian cortex to restore spontaneous ovulation. Drilling is proposed as a second-line treatment in case of failure of treatments with clomid, metformin, or letrozole. The Cochrane 2020 review shows that drilling has the same pregnancy rate as the other second-line treatment: stimulation with gonadotropins [1]. After ovarian drilling, the results show 80% of spontaneous ovulation within 3 months and 50% of spontaneous pregnancy within a year; these results are effective in the long term [2]. The techniques used until now were either classic laparoscopy or transvaginal hydrolaparoscopy, which is currently not feasible owing to the cessation of the kit [3,4]. We present to you a new surgical technique: ovarian drilling by vNOTES. This new technique is minimally invasive, without scarring on the abdomen, and very well tolerated. It allows simultaneous ovarian drilling and fertility workup with assessment of tubal patency and uterine cavity by hysteroscopy. It is recommended to use bipolar energy to reduce ovarian lesions and limit the risk of adhesion [5]. INTERVENTIONS: Transvaginal laparoscopic ovarian drilling is a minimally invasive surgical technique using a vNOTES kit from Applied Medical (Rancho Santa Margarita, CA), a hysteroscope of 5 mm with an operating channel from Delmont Imaging (La Ciotat, France), and a bipolar spring electrode, Versapoint from Olympus (Hamburg, Germany). The key steps to perform this surgery are as follows: 1. Perform a diagnostic hysteroscopy with vaginoscopy 2. Perform a posterior colpotomy 3. Introduce the Alexis retractor into the Douglas and place the GelPOINT with 2 sleeves 4. Introduce the hysteroscope into the pelvic cavity with serum saline, using a pressure of approximately 150 mm Hg 5. Drill approximately 10 holes on each ovary using the bipolar electrode 6. Explore the pelvic cavity with the possibility of performing a blue test for tubal patency 7. Suture the posterior vagina CONCLUSION: Ovarian drilling is a surgical treatment proposed after the failure of first-line treatments in polycystic ovary syndrome to obtain long-term spontaneous ovulations. The development of minimally invasive techniques such as vNOTES will highlight this treatment and allow it to be performed easily and with minimal adverse effects on patients, especially in bariatric women for whom the vNOTES technique provides easier access to their pelvic cavity than abdominal laparoscopy.

Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial.

STUDY OBJECTIVE: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy. DESIGN: A prospective single-arm, first-in-human clinical study. SETTING: Multicenter study involving 6 centers in France, Belgium, and the Netherlands. PATIENTS: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study. INTERVENTIONS: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure. MEASUREMENTS AND MAIN RESULTS: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs. CONCLUSION: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data.

Post procedural pregnancy occurrence risk after endometrial ablation.

OBJECTIVE: The objective of the study was to analyse the pregnancy rate after curettage, 1G (Endometrial resection) and 2G (Endometrial ablation) procedures in women with abnormal uterine bleeding (AUB-O,E,N) to evaluate the rate of pregnancy following these procedures and to improve pre and post-therapeutic women information. METHODS: This retrospective study analyzed data extracted from the French Hospital medical information database. All hospital stays with a diagnostic code for AUB and an appropriate surgical procedure coded between 2009 and 2015 were identified. A total of 109,884 women were included. Of these, 88,165 were followed up for 18 months, 80,054 for 24 months and 33,251 for 60 months. Outcomes were compared between second generation (2G) procedures, first-generation (1G) procedures (endometrial resection) and curettage. The rate of pregnancy was the primary end point. RESULTS: 7863 women underwent a 2G surgical procedure (7.2%), 39,935 a 1G procedure (36.3%) and 38,923 a curettage (35.4%). The mean age of the women was 46 years (IC.95: 36.7-52.5), with no difference in age between groups. The rate of pregnancy after 2G, 1G and curettage was respectively 13 (1.5%), 617 (10.1%) and 1025 (11.1%). The primary endpoint was significantly different between 2G and 1G and curettage (p<0.0001) CONCLUSION: 2G procedures result in lower risk of pregnancy without requiring specific training for surgeons. However, endometrial ablation cannot be considered as a sterilization method nor an effective contraceptive procedure. In the absence of sterilization of either partner, women should continue to use contraception whatever their age and menstrual status.

A protocol for developing a core outcome set for ectopic pregnancy.

BACKGROUND: Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. STUDY AIM: To develop and implement a core outcome set to guide future research in ectopic pregnancy. METHODS AND ANALYSIS: We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus 'core' outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. TRIAL REGISTRATION: COMET 1492 . Registered in November 2019.