vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large uteri: study protocol for a multicentre randomised controlled trial.

Background: In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (> 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery. Objectives: To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (>280g). Materials and Methods: A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (> 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy. Main outcome measures: The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team. Results: 248 women will be randomised. Conclusion: This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy. What's new?: This trial will evaluate the vNotes for large uteri.

[Simulation training for French obstetrics and gynecology residents: A national survey in 2022]. / Formation initiale par la simulation pour les internes français de gynécologie et obstétrique : état des lieux en 2022.

OBJECTIVES: To evaluate the use of simulation among French Obstetrics and Gynecology residency programs. METHODS: A survey was conducted with all 28 French residency program directors. The questionnaire covered equipment and human resources, training programs, types of simulation tools and time spent. RESULTS: Of the cities hosting a residency program, 93% (26/28) responded regarding equipment and human resources, and 75% (21/28) responded regarding training program details. All respondents declared having at least one structure dedicated to simulation. A formal training program was reported by 81% (21/26) of cities. This training program was mandatory in 73% of the cases. There was a median number of seven senior trainers involved, three of whom had received a specific training in medical education. Most of declared simulation activities concerned technical skills in obstetrics and surgery. Simulations to practice breaking bad news were offered by 62% (13/21) of cities. The median number of half-days spent annually on simulation training was 55 (IQR: 38-83). CONCLUSION: Simulation training is now widely available among French residency programs. There remains heterogeneity between centers regarding equipment, time spent and content of simulation curricula. The French College of Teachers of Gynecology and Obstetrics has proposed a roadmap for the content of simulation-based training based on the results of this survey. An inventory of all existing "train the trainers" simulation programs in France is also provided.

Evaluation of surgical treatment of genital prolapse using synthetic mesh in an outpatient procedure and patient satisfaction.

OBJECTIVE: To study a new strategy for one day prolapse surgery with mesh, to identify risk factors for one day procedure failure and patient satisfaction. METHODS: This retrospective observational study was conducted at Saint Etienne University Hospital, France. All patients who received a prolapse treatment by synthetic mesh between January 2016 and April 2019 in one day surgery procedure were included in the study. Exhaustive variables was collected and all patients were contacted for a satisfaction survey. RESULTS: During the periode patients were included. 6 of them required readmissions included 5 hospitalization for urinary retention and 1 for abnormal bleeding. Among the patients, 87% were satisfied. Only the anesthetic management was significantly associated with an ambulatory surgery success (p = 0,02) and satisfaction (p = 0,001). CONCLUSION: This study shows the technical feasibility and safety of prosthetic prolapse surgery during outpatient hospitalization. The success of a rapid pathway in one day surgery depends on a good selection of patients, proper planning of surgical procedures and optimization of anesthesia protocols. The prevention of outpatient failures is justified for medical and economic reasons respecting the quality and safety of patients.

[Clinical path and life quality of women under 75 years with an urinary incontinence relevant to surgical treatment]. / Parcours de soins et qualité de vie des femmes de moins de 75 ans relevant d'une prise en charge chirurgicale pour incontinence urinaire.

OBJECTIVES: Urinary incontinence has a high prevalence and a significant impact on quality of life, especially for women. Surgery is possible after failure of lifestyle changes, physiotherapy. Analyzing the care pathway of women under 75 years of age who have undergone surgery for urinary incontinence in link with recommendation and suggest possible improvements. METHODS: Quantitative, multicentric, retrospective survey carried out between 10/09/2019 and 25/11/2019, based on anonymous self-report questionnaire, among women aged between 32 and 75 and operated in different hospitals in Loire (France). RESULTS: Ninety-three answers were exploited out of 204. Among the women, 49.5 % had stress, 50.5 % mixed incontinence. Before the intervention, it had evolved for 5 years on average and caused discomfort evaluated at an average 7.5/10. Eighty percent frequently used protective pads and bladder training. Lifestyle changes and the voiding diary were not used much. Eighty-six percent of women felt comfortable to speak to a physician. Seventy-three percent had performed a urodynamic test, 47 % an abdominal ultrasound and 40 % a urinalysis. Seventy-seven percent performed physiotherapy, 39 % self-administered physiotherapy, 7 % used medication. The postoperative quality of life was evaluated at 7.8/10; 58 % felt healed and 69 % considered their sex life had improved. CONCLUSIONS: The care pathway could be improved through systematic screening for urinary incontinence and its impact. The development of a care plan to coordinate and propose quick care could help patients to improve their life.

[Outpatient breast cancer surgery: Patient satisfaction study and the role of the attending physician]. / La chirurgie ambulatoire du cancer du sein : étude de satisfaction des patientes et place du médecin traitant.

OBJECTIVES: To evaluate the satisfaction of patients with breast cancer treated surgically in an outpatient setting and the role of the attending physician. METHODS: This prospective satisfaction study focused on patients who had a breast cancer surgery as an outpatient procedure, between February and October 2018, at the CHU and Clinique Mutualiste chirurgicale de Saint-Étienne, Loire, France. The data were collected via a satisfaction survey, which was given to the patients during the postoperative visit. RESULTS: One hundred and four patients were included. The most frequent surgery was partial mastectomy with sentinel lymph node (63.5%). On overall breast cancer surgery, 47.6% were performed on an outpatient basis. Ninety-seven percent of the patients were satisfied, 96.9% would have recommended this procedure to a friend and 47% could resume their daily activities as early as the second day. Among the patients, 16.2% would have preferred to stay on day more in hospital after the surgery. This preference was related to the complexity (P=0.035) and duration of the surgery (P=0.025), fatigue (P=0.03) and feeling of isolation (P=0.016). Among the patients, 25.5% saw their doctor for organic, psychological, administrative, monitoring and informational issues. CONCLUSIONS: Outpatient breast cancer surgery seems safe and qualitative. Standardized procedures, relevant information about the outpatient procedure and specificities of this type of care, as well as the transmission of information with the attending physician are the keys to success.

Outcomes and treatments of IB1 cervical cancers with high recurrence risk: A 13 years' experience.

PURPOSE: The aim of the present study was to identify management strategies and outcomes of patients with stage IB1 cervical cancer with high recurrence risk. MATERIALS AND METHODS: Medical files of all consecutive patients treated between 2004 and 2017 with external beam radiotherapy and/or brachytherapy for IB1 cervical cancer, whatever the lymph node status, were retrospectively reviewed. RESULTS: Forty-two patients were included, with a median age of 49.8 years old. Median tumour size, estimated with the initial pelvic magnetic resonance imaging, was 26mm (interquartile range [IQR]=19.5-35). Histological types were mainly squamous cell carcinoma (59.5%) and adenocarcinoma (33.3%). Lymphovascular invasion was reported for 38.1% of patients. Pelvic lymph nodes were involved for eight patients (19.0%). Surgery was performed for 39 patients (92.9%). A neoadjuvant treatment was delivered for 20 patients (47.6%), an adjuvant treatment for 19 patients (45.2%) and an exclusive radiotherapy (with or without chemotherapy) followed by brachytherapy for three patients (7.1%). Pathologic complete response was achieved in 61.5% of patients. With a median follow-up of 5.8 years (IQR=2.6-9.4), five patients (11.9%) experienced a tumour relapse. The five-year disease-free survival was 79.5% (95% confident interval [CI]=66.9-94.4), the five-year overall survival was 87.8% (95% CI=77.2-99.8), and the five-year disease-specific survival was 94.2% (95% CI=86.7-100). CONCLUSION: In current clinical practice, tailored treatments are delivered, and seems to give correct therapeutic index. However, clinical trials are needed to standardise treatment according to patient characteristics and recurrence risk factors.

[Vaginal hysterectomy in outpatient procedure: Feasibility and satisfaction study]. / L'hystérectomie par voie vaginale en ambulatoire : étude de faisabilité et de satisfaction des patientes.

OBJECTIVES: To study the feasibility and patient satisfaction for vaginal hysterectomy in a new outpatient procedure. METHODS: This retrospective study was directed in CHU de Saint-Étienne, Loire, France. All patient who underwent a vaginal hysterectomy in outpatient procedure were included from January 2014 and January 2017. Descriptive data were collected and all patients were called back for satisfaction study. RESULTS: Sixty-five patients were included. Vaginal hysterectomy was performed for 52.3% for pre-menopause bleeding, 24.6% for prolapse, 15.4% for uterine fibroids and 7.6% diverse. Outpatient procedure was performed in 96.9%. Peroperative outcome from Oslo classification were 1.5% for grade 1 and 1.5% for grade 2. Postoperative complications from Clavien-Dindo classification were: 16.9% grade 1 and 6.2% grade 2. Mean postoperative pain scale was 1.02 between H1 and H3 post-operative and 0.84 between H3-H6. Among the patients, 89.2% were very satisfied, 91.9% recommend the same outpatient procedure and 43.2% assumed their daily life since first day postoperative. CONCLUSION: Vaginal hysterectomy in outpatient procedure is today's reality. It is a simple, economic, with few postoperative complications and very high satisfaction scores procedure. Standardized procedure, good patient selection and information are necessary to minimize complications.

Reduction of the use of antimicrobial drugs following the rapid detection of Streptococcus agalactiae in the vagina at delivery by real-time PCR assay.

OBJECTIVE: To assess whether the determination of the presence of group B streptococci (GBS) in the vagina using a rapid polymerase chain reaction (PCR) assay at delivery was able to spare useless antimicrobial treatments, as compared with conventional culture at 34-38 weeks of gestation. DESIGN: Practical evaluation and prospective cost-effectiveness analysis. SETTING: A university hospital in France. POPULATION: A cohort of 225 women in labour at the University-Hospital of Saint-Etienne. METHODS: Each woman had a conventional culture performed at 34-38 weeks of gestation. At the beginning of labour, two vaginal swabs were sampled for rapid PCR testing and culture. The decision to prescribe a prophylactic antimicrobial treatment or not was taken according to the result of the PCR test. A comparative cost-effectiveness analysis of the two diagnostic strategies was carried out. MAIN OUTCOME MEASURES: Number of women receiving inadequate prophylactic antimicrobial drugs following each testing strategy, costs of PCR testing and culture, frequency of vaginal GBS, and diagnostic performance of the PCR test at delivery. RESULTS: The percentage of unnecessarily treated women was significantly reduced using the rapid test versus conventional culture (4.5 and 13.6%, respectively; P < 0.001). The rate of vaginal GBS at delivery was 12.5%. The incremental cost-effectiveness ratio (ICER) for each inadequate management avoided was €36 and €173 from the point of view of the healthcare system and hospital, respectively. CONCLUSIONS: The PCR assay reduced the number of inadequate antimicrobial treatments aimed to prevent the early onset of GBS disease. However, this strategy generates extra costs that must be put into balance with its clinical benefits.

[Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. / Infiltration peropératoire de lévobupivacaïne après césariennes: étude randomisée en double insu contre placebo.

OBJECTIVES: The efficacy of single-dose intraincisional infiltration with levobupivacaine in postoperative analgesia and chronic pain after caesarean sections is unknown. STUDY: A placebo-controlled double-blind randomized trial. PATIENTS AND METHODS: After ethical approval, and written inform consent, 140 women scheduled for a caesarean section were randomly assigned and received 30mL of levobupivacaine 0.5% (L group) or saline (placebo-P group) into their wound. The primary endpoint was morphine consumption (using intravenous morphine patient-controlled analgesia) for the first 24h after surgery. At 1h to 48h, side effects, pain at rest and pain 2months later were recorded. RESULTS: All included patients had similar demographic and surgical characteristics. The morphine consumption was significantly lower in the L group at h6, h8 and h12 (considering both total intake and each request). At h4, the mean total morphine consumption was 25 (12) mg in the L group versus 31 (14) mg in the P group (P=0.05). Time until discharge and side effects including nausea-vomiting (14 vs 20%), wound scar complications (6 vs 8%) and chronic pain after 2months (25% in both groups complained of small pain, and 75% no pain) were similar between the two groups (P>0.05). CONCLUSION: Single-dose local infiltration of levobupivacaine 0.5% reduced opioid requirement at 12h, with no difference after 24h. www.clinicaltrials.com, number: NCT00621907.

[A new low-cost webcam-based laparoscopic training model]. / Intérêt et performances d'un pelvitrainer portable pour l'entraînement à la laparoscopie.

OBJECTIVES: To validate a new laparoscopy home training model (GYN Trainer®) in order to practise and learn basic laparoscopic surgery. PATIENTS AND METHOD: Ten junior surgical residents and six experienced operators were timed and assessed during six laparoscopic exercises performed on the home training model. RESULTS: Acquisition of skill was 35%. All the novices significantly improved performance in surgical skills despite an 8% partial loss of acquisition between two training sessions. Qualitative evaluation of the system was good (3.8/5). DISCUSSION AND CONCLUSION: This low-cost personal laparoscopic model seems to be a useful tool to assist surgical novices in learning basic laparoscopic skills.

[Exclusive radiotherapy and concurrent endocrine therapy for the management of elderly breast cancer patients: case study and review of hypofractionated schemes]. / Hormonoradiothérapie exclusive dans la prise en charge du cancer du sein de la personne âgée : cas clinique et revue de la littérature des schémas hypofractionnés.

Normofractionated radiotherapy is standard for adjuvant management of patients treated with breast conservative surgery for breast cancer. However, many elderly patients are not eligible to such strategy, either because of concurrent diseases, or because the tumor is inoperable. Several protocols of exclusive radiotherapy have been reported in the literature, frequently using hypofractionated radiotherapy and endocrine therapy. We report a case of a patient treated with exclusive endocrine and radiotherapy and address the state of the art on hypofractionated schemes for the management of elderly breast cancer patients. While hypofractionated radiotherapy does not compromise the oncologic or cosmetic outcome, there is no prospective data that assesses the place of radiotherapy for the exclusive treatment of elderly patients. This strategy should be further assessed in clinical randomized trial.

[Prenatal diagnosis and management of isolated bladder exstrophy]. / Diagnostic anténatal et prise en charge des extrophies vésicales isolées.

The isolated bladder extrophy is a major congenital malformation which prenatal diagnosis is essential. It is based on the non-visualization of the bladder during the first trimester ultrasound but in most cases, it is confirmed by the morphological ultrasound of the second trimester. For the baby, the prognosis of life quality depends on the accurate identification of the malformation, the foetal sex and the associated pathologies. Thus, a detailed ultrasound evaluation is necessary and requires an operator experienced in the search of malformations. As this abnormality has important aesthetic and functional consequences, a multidisciplinary management is required for a good information of the couple. The continuation of pregnancy is currently possible but the couple should be informed that after surgery, often a major one, more than 75% of children will have a urinary continence by reconstruction or bypass. Furthermore, their ability of reproduction will need to be medically improved.

Paternal endothelial protein C receptor 219Gly variant as a mild and limited risk factor for deep vein thrombosis during pregnancy.

BACKGROUND: Half of all venous thromboembolism (VTE) cases during pregnancy are associated with a maternal thrombophilia. The influence of paternal genotype on the placenta and in the genesis of VTE has not been described. OBJECTIVES: To determine if the maternal and paternal Ser219Gly dimorphism of the endothelial protein C receptor (EPCR), evaluated through detection of the PROCR 6936G allele, is a risk factor for VTE during pregnancy. METHODS: Using a case-control study nested in the NOHA first cohort of primigravidae, 66 patient couples with a first episode of gestational VTE and randomly selected non-thrombotic control couples were investigated. For each couple, factor V gene (F5) G1691A, factor II gene (F2) G20210A, factor XII gene (F12) C46T and PROCR A6936G polymorphisms were determined. RESULTS: Only maternal F5 1691A, F2 20210A and F12 46T alleles were independently associated with iliac and infra-iliac deep vein thromboses (DVT). The maternal PROCR 6936G allele was a mild risk factor for iliac DVT (OR = 5.5 [2.3-13.0]). The paternal PROCR 6936G allele was also a mild independent risk factor for iliac DVT (OR = 2.6 [1.1-6.2]) and only during pregnancy (rather than postpartum) among maternal carriers of the F5 1691A allele (OR = 77.6 [4.2 to > 999.9]). CONCLUSIONS: The paternal PROCR 6936G allele could be a risk factor for maternal iliac DVT. Its impact was milder than the F5 1691A and F2 20210A polymorphisms in mothers. We hypothesize that the prothrombotic effect of the paternal PROCR 6936G allele is localized. Therefore, DVT during pregnancy may be influenced by trophoblastic cell-surface proteins inherited from both maternal and paternal alleles.

[Risk factors of mesh exposure after transvaginal repair of genital prolapse]. / Facteurs de risque d'exposition de prothèse dans les cures de prolapsus génital par voie vaginale.

OBJECTIVES: We analysed the risk factors of vaginal surgery of pelvic organ prolapse with non resobable prothesis. PATIENTS AND METHODS: This is a continuous, retrospective study of the 208 patients who had surgery between 2003 and 2007. Depending on the localisation of the prolapse, they had a prothesis under the bladder and/or a posterior tape through the sacrospinous ligament. An hysterectomy and a levator myorraphy were done if necessary. RESULTS: After a 3 years follow-up, we found 16.8% mesh exposure (23% were treated by a conservative way). The highest rate of incidence was at 4 and 10 months. The independent risk factors of exposure were the kind of prothesis, age under 60 and concomitant hysterectomy. Women treated by vaginal estrogens and those operated by the most experienced surgeon had less exposure. We had 5% of complications during the surgery. DISCUSSION AND CONCLUSION: Hysterectomy, kind of prothesis and inverted T colpotomy of Crossen are well known risk factors. Age, stage of prolapse, size of prothesis and surgeon experience are discussed. Vaginal surgery of pelvic organ prolapse with non resobable prothesis must be used only when prolapse stage is higher than 3, hysterectomy has to be avoid and vaginal estrogens must be prescribed.

[Health-related quality of life in women operated on by surgical anti-incontinence procedures: comparison of three techniques]. / Qualité de vie après cure d'incontinence urinaire d'effort: comparaison de trois techniques.

OBJECTIVES: To assess the health-related quality of life (Contilife) after three surgical anti-incontinence procedures (Tension-Free Vaginal Tape [TVT], Transobturator Vaginal Tape [TOT], and Transobturator Vaginal Tape [TVT-O]). PATIENTS AND METHODS: We performed a prospective analysis of 90 women (30 TVT, 30 TOT, 30 TVT-0) with genuine stress incontinence pre- and postoperatively at 18 months. The objective cure rate was determined by clinical and urodynamic examination and the subjective cure rate by the Contilife questionnaire. RESULTS: Prior to surgery, patients complained more of effort activities, followed by global well-being. Postoperatively, all domains improved significantly without statistical difference between the three groups and 90% of the patients would advise the intervention to one of their friends. DISCUSSION AND CONCLUSION: Surgical outcomes vary greatly depending on the methodology of the study. Health-related quality of life seems paramount to decide time of surgery and to evaluate postoperatory results. We have chosen the Contilife questionnaire because of its scientific and clinical validity, reliability, responsiveness and linguistic validation. These results confirm that TVT/TOT/TVT-O procedures are a safe and effective surgical method and that they significantly improved health-related quality of life.

[Treatment of breast cancer between 1985 and 2005 at Saint-Etienne University Hospital: contribution of mammography screening. Retrospective study of 473 patients]. / Prise en charge des carcinomes mammaires infiltrants entre 1985 et 2005 au CHU de Saint-Etienne : apport du dépistage par mammographie. Etude rétrospective de 473 patientes.

OBJECTIVE: Study the contribution of breast cancer screening by mammography on the quality of diagnosis and treatment of patients admitted at Saint-Etienne University Hospital between 1985 and 2005. PATIENTS AND METHODS: Descriptive and retrospective study of 473 breast cancer patients between 1985 and 2005, with a stratified sampling over the year, and comparison of the various characteristics between detected and not detected patients. RESULTS: Patients diagnosed by a mammography screening present, in a statistically significant way, smaller size tumours, less nodes and metastatic attacks, more conservative surgery and less chemotherapy. The rate of global survival after years years is increased: 93.69% against 86.94% for patients who did not participate in an organized screening (p=0,0471). DISCUSSION AND CONCLUSION: Mammography screening allows optimization of the health care. In the next years, we should continue the development of mass screening and convince the actors of individual screening to join organized campaigns.

[Risk factors for tumor recurrence after breast conserving therapy: about 254 cases]. / Facteurs de risque de récidive des cancers du sein traités par chirurgie conservatrice: à propos de 254 cas.

OBJECTIVES: To retrospectively study our risk factors of recurrence of infiltrating breast cancers treated by conservative therapy in Saint-Etienne university hospital. MATERIALS AND METHODS: From 1997 to 2000, 254 patients were treated by conservative treatment. Through a univariate then multivariate analysis we identified factors of locoregional and metastatic recurrences. RESULTS: The global rate of recurrence is 21.6%. There is 9.8% of local recurrence, 2.3% of node recurrence and 14.9% of metastatic one. Plurifocality OR: 3.7, tumoral type OR: 2.93, lymphovascular invasion OR: 3.6 and young age are factors of locoregional recurrence. For distant metastases, the recurrences factors are the tumoral size, the node status, the absence of estrogens receptors, the SBR rank, the locoregional recurrence, the rise of CA 15-3 and the addition of chemotherapy but only the SBR rank OR: 2.56 appears in multivariate analysis. CONCLUSION: On one hand, this study revealed known risk factors already used to decide on the adjuvant therapy. On the other hand, plurifocality and lobular cancer must be taken into consideration before a conservative therapy. The surgery will probably be more extensive under these conditions.

[Prophylaxis of thromboembolic complications in obstetrics and gynaecology]. / Maladie thromboembolique périopératoire et obstétricale. Pathologie gynécologique et obstétricale.

Venous thromboembolism is a leading cause of maternal mortality in many countries, including France. Most enquiries have repeatedly demonstrated that many deaths could be avoided, suggesting the need to update and ensure a wider diffusion of recommendations. Although thromboembolism-induced maternal death plays a major role, the absolute incidence of events remains low, reducing the ability to perform well-designed research and the level of recommendations presented. Many personal or pregnancy-related factors have been identified as increasing the risk of thromboembolism in pregnant patients but few of them have been associated with a significantly increased risk. A history of thromboembolic event and some thrombophilic factors (including antithrombin deficiency and antiphospholipid syndrome) carry the greatest risk. Pregnancy itself, caesarean delivery and the postpartum period, although associated with an increased risk play a minor role when not combined with other risk factors. Prophylactic treatment relies mainly on low molecular weight heparins which safety is now well established in pregnant patients. Dose and duration of treatment should be adapted to the perceived level of risk. The occurrence of a thromboembolic event is also increased after gynaecological surgery but major and cancer surgery carry the greatest risk. Here also, low molecular weight heparins play a leading role, although non pharmacologic means are useful. Dose and duration should be dependent on the level of risk.