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.

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.

[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.

Prediction of small-for-gestational-age neonate by third-trimester fetal biometry and impact of ultrasound-delivery interval.

OBJECTIVES: To compare third-trimester ultrasound screening methods to predict small-for-gestational age (SGA), and to evaluate the impact of the ultrasound-delivery interval on screening performance. METHODS: In this prospective study, data were collected from a multicenter singleton cohort study investigating the links between various exposures during pregnancy with birth outcome and later health in children. We included women, recruited in the first trimester, who had complete outcome data and had undergone third-trimester ultrasound examination. Demographic, clinical and biological variables were also collected from both parents. We compared prediction of delivery of a SGA neonate (birth weight < 10th percentile) by the following methods: abdominal circumference (AC) Z-score based on Hadlock curves (Hadlock AC), on INTERGROWTH-21st Project curves (Intergrowth AC) and on Salomon curves (Salomon AC); estimated fetal weight (EFW) Z-score based on Hadlock curves (Hadlock EFW) and on customized curves from Gardosi (Gardosi EFW); and fetal growth velocity based on change in AC between second and third trimesters (FGVAC). We also assessed the following ultrasound-delivery intervals: ≤ 4 weeks, ≤ 6 weeks and ≤ 10 weeks. RESULTS: Third-trimester ultrasound was performed in 1805 patients with complete outcome data, of whom 158 (8.8%) delivered a SGA neonate. Ultrasound examination was at a median gestational age of 32 (interquartile range, 31-33) weeks. The ultrasound-delivery interval was ≤ 4 weeks in 17.2% of cases, ≤ 6 weeks in 48.1% of cases and ≤ 10 weeks in 97.3% of cases. Areas under the receiver-operating characteristics curve (AUC) were 0.772 for Salomon AC, 0.768 for Hadlock EFW, 0.766 for Hadlock AC, 0.765 for Intergrowth AC, 0.708 for Gardosi EFW and 0.674 for FGVAC (all P < 0.0001). The screening method with the highest AUC for an ultrasound-delivery interval ≤ 4 weeks was Salomon AC (AUC, 0.856), ≤ 6 weeks was Hadlock AC (AUC, 0.824) and ≤ 10 weeks was Salomon AC (AUC, 0.780). At a fixed 10% false-positive rate, the best detection rates were 60.0%, 54.1% and 42.1% for intervals ≤ 4, ≤ 6 and ≤ 10 weeks, respectively. CONCLUSION: Third-trimester ultrasound measurements provide poor to moderate prediction of SGA. A shorter ultrasound-delivery interval provides better prediction than does a longer interval. Further studies are needed to test the effect of including maternal or biological characteristics in SGA screening. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Prediction of neonatal outcome of TTTS by fetal heart and Doppler ultrasound parameters before and after laser treatment.

OBJECTIVES: To determine the prognostic value of fetal Doppler and echocardiographic parameters for neonatal survival up to 30 days after laser coagulation in monochorionic pregnancies complicated by twin-twin transfusion syndrome (TTTS). METHODS: Fetal echocardiography and outcome data of consecutive cases of TTTS treated by laser were retrospectively reviewed. Hemodynamic and cardiac function parameters were collected before and after laser. RESULTS: Between February 2006 and January 2015, 106 fetoscopic laser were performed. The final analysis was limited to cases with ultrasound within 2 days before laser (n = 77) and 4 weeks after laser (n = 86). Overall neonatal survival rate was 64.9% (135/208) and 77.9% of pregnancies (81/104) had at least one baby alive. For the recipient twin, the preoperative predictors of neonatal survival were umbilical artery (UA) pulsatility index (PI), cerebro-placental PI ratio, UA end diastolic flow (EDF), ductus venosus a-wave, right ventricular myocardial performance index (RV-MPI) and CHOP score. The postoperative predictors of donor survival were donor RV-MPI and recipient UA EDF, umbilical vein pulsations, tricuspid regurgitation, cardiac hypertrophy and CHOP score. CONCLUSION: The hemodynamic predictors of postnatal survival after laser were preoperative signs of recipient cardiomyopathy and postoperative signs of cardiac overload in both twins. © 2016 John Wiley & Sons, Ltd.