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.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).

[Cystocele repair by a light tension-free vaginal mesh: results after 6 years of follow-up]. / Cure de cystocèle par prothèse vaginale libre de faible grammage : résultats à 6 ans.

INTRODUCTION: The objective of this study was to evaluate the long-term anatomical and functional efficacy, but also the safety of tension-free vaginal mesh in cystocele repair. METHODS: This retrospective and monocentric study included 90 women who underwent a prolapse repair between June 2006 and November 2008. A light-weight polypropylene vaginal mesh (22g/m2, Novasilk COLOPLAST®) was used without any fixation. Females were followed at 1 month, 1 year, 3 years and 6 years. Only long-term results are presented in this study. The anatomical result was assessed by the POP-Q classification and the functional results by standardized symptoms (PFDI-20), sexuality (PISQ-12) and quality of life (PFIQ-7) questionnaires. RESULTS: 6 years after surgery, the follow-up rate was 74%. Anatomically, the prolapse recurrence rate (Ba≥0) was 17% (n=8). Functionally, the overall patient satisfaction rate was 89%. Quality of life and symptoms scores (4,11±8.45 vs. 17.5±14.4 and 35.8±15.9 vs 94±23.4 respectively) were significantly improved (p<0.001). Concerning the prevalence of the complication, the retraction and exposition rate was 1.7% (n=1) and a re-intervention rate was 6.7% (n=4). The rate of de novo dyspareunia was 1.7% (n=1). CONCLUSION: In this short retrospective series of vaginal mesh interposition for cystocele repair, the prevalence of medium-term patient satisfaction was high.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

Pelvic adhesions and fertility: Where are we in 2018?

Peritoneal adhesions remain a major public health problem despite the development of laparoscopy. The rules of microsurgery must be known and followed during any pelvic surgery, even in patients who no longer have a desire for pregnancy. Anti-adhesion products are numerous. All have interest, confirmed by anatomical studies showing a smaller extent or a lesser severity of adhesions associated with their use. No studies, however, show clinical benefit in terms of improved pain or postoperative fertility. Pneumoperitoneum parameters, humidification, and lower abdominal pressure should be optimized to limit peritoneal trauma. Peri-operative corticosteroids, whose benefit has been has been demonstrated in at least one randomized trial, should be systematically used.

[Nerve sparing techniques in deep endometriosis surgery to prevent urinary or digestive functional disorders: Techniques and results: CNGOF-HAS Endometriosis Guidelines]. / Les techniques de préservation nerveuse dans la chirurgie de l'endométriose profonde pour prévenir les séquelles fonctionnelles urinaires et digestives : modalités techniques et résultats. RPC Endométriose CNGOF-HAS.

OBJECTIVES: To evaluate the feasibility and functional urinary and digestive results of nerve sparing techniques in endometriosis surgery. METHODS: A research on the medline/pubmed database using specific keywords (nerve sparing, endometriosis, pelvic nerves) identified 7 publications among about 50 whose purpose was to describe the feasibility, the techniques and the functional results of nerve preservation in this indication. Among them there are: 2 uncontrolled retrospective studies, 3 prospective non-randomized studies, a meta-analysis and a review of the literature. RESULTS: Nerve preservation requires a perfect knowledge of the anatomy of the pelvic autonomic system. The laparoscopic approach is preferred by the different authors due to its anatomical advantage. The feasibility of this technique seems to be demonstrated despite certain limitations in the different studies and depending of the retroperitoneal extension of the lesions. When feasible, it is likely to significantly improve postoperative urinary function (urinary retention) compared to a conventional technique. It is observed no difference regarding digestive function. CONCLUSIONS: Nerve sparing in this indication is a technique the feasibility of which has been demonstrated and is subject to the topography and extent of the disease. In the absence of invasion or entrapment of pelvic autonomic nerves by endometriosis, this technique improves postoperative voiding function (NP3). During pelvic surgery for endometriosis, it is recommended to identify and preserve autonomic pelvic nerves whenever possible (GradeC).

Accuracy of a rapid intrapartum group B Streptococcus test: A new immunochromatographic assay.

OBJECTIVES: To decrease the incidence of early-onset group B streptococcal (GBS) disease, a culture-based screening of all pregnant women at 35-37 weeks is recommended. This gold standard test requires 24-72hours culture. This delay precludes its use for intrapartum screening. This study assesses a new immunoassay, the DIMA test, for identifying GBS-positive patients in the labor ward. MATERIALS AND METHODS: This was a prospective observational study of 195 pregnant women presenting with full-term labor at a single site in France between June and August 2012. We assessed the diagnostic accuracy of intrapartum DIMA testing as compared to intrapartum GBS culture and prenatal screening at 35-38 weeks. RESULTS: The DIMA test sensitivity and specificity were 57.1% and 83.2%, respectively, as compared to 42.9% and 97% for prenatal culture screening. CONCLUSION: The DIMA test assay is a rapid and inexpensive test for the detection of maternal GBS colonization in the labor ward. Its sensitivity is higher than antepartum culture but its specificity is lower. Its performance was inferior to that reported for rapid polymerase chain reaction assays.

Development of an ovine model for training in vaginal surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This aim of this study was to evaluate the feasibility and usefulness of an ovine model for training in vaginal surgery. METHODS: Four senior urogynaecological surgeons and five residents attended five sessions of vaginal surgery for pelvic organ prolapse (POP) in five old multiparous female sheep. Urogynaecological examinations were performed and measurements similar to the POP-Q classification in humans were obtained. Standard POP surgical procedures with and without mesh were performed. A pelvic CT scan was done on one animal and the structures were compared with the pelvic structures in a woman. After the feasibility of vaginal surgery had been established in three cadavers, surgery was performed in two living animals under general anaesthesia and was followed by laparoscopy to explore the internal pelvic anatomy. RESULTS: We found anatomic similarities in the vaginal and pelvic structures between sheep and women. After caudal traction on the cervix, all five sheep had significant POP of stage 3 or 4. We proved the feasibility of all types of vaginal surgery in this animal model: traditional anterior and posterior repair, apex fixation and anterior wall repair with mesh. The video shows the internal pelvic anatomy and different vaginal procedures. CONCLUSION: This study showed that training in vaginal surgery for POP is feasible and useful in an animal model, the ewe, that has vaginal and pelvic structures very similar to those in women.

[About a case of uterine per-partum rupture, 37months after resection of a rectovaginal endometriosis nodule]. / À propos d'un cas de rupture utérine per-partum, 37 mois après une résection d'un nodule recto-vaginal d'endométriose.

Endometriosis is a common condition in women, whose main repercussions are painful symptoms. In addition, it was shown that endometriosis was a major cause of infertility and various obstetric complications could be related to this pathology. Uterine rupture is a rare but serious complication whose incidence tends to decrease with the screening of women at risk, however, its fetal, maternal morbidity and mortality causes remains important. We were confronted with a case of posterior uterine rupture in a patient of 36 years, primipare term exceeded in immediate postpartum period. The patient's primary antecedent of uterine surgery torus was responsible for infertility endometriosis. The outcome was favorable for the mother, after a surgical treatment by laparotomy, and for the child. In the literature, two cases have been reported of uterine rupture after endometriosis surgery, which is why we found it interesting to report this rare case. Given the increase in surgical management of this disease, it seems relevant to ask whether, in the future, we should be more vigilant in monitoring pregnancy for these women.

[Treatment of tubal ectopic pregnancy by methotrexate]. / Utilisation du méthotrexate dans les GEU tubaires.

OBJECTIVES: To make a literature analyse about methotrexate as a treatment of tubal ectopic pregnancy. MATERIALS AND METHODS: We made a PubMed research and found articles, randomized control studies, systematic revues and meta-analyses of the Cochrane Database about ectopic pregnancies treated by methotrexate. We made a summary of these articles. RESULTS: Methotrexate can be used as a treatment of tubal ectopic pregnancy with hCG<5000 UI/L and expectative is an option if hCG level is lower than 1500 UI/L. Medical treatment by methotrexate seems to be less effective than surgical salpingotomy but the rate of recurrence and the rate of intra-uterine pregnancy are similar regardless of the treatment chosen. Fertility seems to be the same after treatment by methotrexate. Economically, methotrexate is less expensive than the surgical management (laparoscopy). CONCLUSION: Methotrexate can be used as a treatment of tubal ectopic pregnancies if every criterions of safety are gathered.

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

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

[Predictors of failed trial of labor in obese nulliparous]. / Facteurs prédictifs d'échec de l'intention de voie basse chez la primipare obèse.

OBJECTIVES: To identify predictors of failed trial of labour (TOL) in obese nulliparous at term. PATIENTS AND METHODS: Retrospective study about 213 nulliparous with a body mass index (BMI) greater than 30kg/m(2) who delivered a vertex singleton after 37 weeks of gestation (WG). Planned caesarean sections were excluded. Maternal, sonographic, per-partum and neonatal characteristics were analyzed according to the mode of entry into labor and delivery route. Univariate and multivariate logistic regression analysis were performed. RESULTS: The cesarean delivery rate was 28%. Induction of labor (aOR=4.3 [1.8-10.7]), prolonged pregnancy (aOR=10.8 [1.7-67.6]), macrosomia (aOR=5.6 [1.1-27.3]), meconium-stained amniotic fluid (aOR: 2.57 [1.03-6.42]), use of trinitrine (aOR=5.5 [1.39-21.6]) and neonatal head circumference greater than 35cm (aOR=3.1 [1.2-8.0]) were predictors of failed TOL. There was no significant correlation between failed TOL and preconceptional BMI. Univariate analysis revealed an association between excessive weight gain and failed TOL. DISCUSSION AND CONCLUSION: Predictors of failed TOL are the same in obese and non-obese women. Preconceptional BMI does not predict failed TOL in this nulliparous obese population.

[Prenatal diagnosis and evolution of patent urachus]. / Diagnostic et évolution prénatale de l'ouraque perméable: à propos d'un cas.

Prenatal ultrasonographic features of patent urachus consist in anechoic proximal cord cyst communicating with the bladder associated with large umbilicus. Distinction should be made with omphalocele and bladder extrophy. Spontaneous evolution leads to rupture during mid-trimester and bladder protrusion. Karyotyping is not mandatory in isolated typical cases. Early postnatal surgery is usually required.