Abstract STUDY QUESTION Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER This study ...demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien–Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien–Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien–Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S) The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier NCT04494568.
Objective
Urinary incontinence (UI) is often considered to be an age‐related disease that develops gradually as women grow older. Much remains to be learnt about factors that promote its incidence or ...its remission. Our objective was to assess its incidence and risk factors.
Design
Longitudinal cohort study.
Setting
French GAZEL cohort.
Population
A cohort of 4127 middle‐aged women (aged 47–52 years at baseline) over an 18‐year period (1990–2008).
Methods
UI was defined as ‘difficulty retaining urine’. The question was asked at baseline and repeated every 3 years over an 18‐year period. Two groups (UI incidence and remission) were analysed according to status at baseline (continent or incontinent). A multivariable analysis (Cox model) was used to estimate the risk factors for UI incidence and remission.
Main outcome measures
Annual incidence and remission rates and risk factors for UI incidence and remission.
Results
The annual incidence and remission rates for UI were 3.3% and 6.2%, respectively. High educational level (hazard ratio HR = 1.28; 95% confidence interval 95% CI = 1.05–1.55), parity, i.e. at least one baby versus no baby (HR = 1.64; 95% CI = 1.19–2.27), menopause (HR = 5.44; 95% CI = 4.47–6.63), weight gain, i.e. for each kilogram change in weight (HR = 1.00; 95% CI = 1.00–1.02), onset of depressive symptoms (HR = 1.31; 95% CI = 1.09–1.57) and impairment in health‐related quality of life incidence (social isolation dimension HR = 1.29; 95% CI = 1.04–1.60 and energy dimension HR = 1.41; 95% CI = 1.17–1.70) were associated with an increased probability of UI. The factors associated with persistent UI were age (HR = 0.58; 95% CI = 0.55–0.61), weight gain (HR = 0.99; 95% CI = 0.98–0.99) and transition to menopausal status (HR = 1.54; 95% CI = 1.19–1.99).
Conclusions
Our study suggests that, in our population of middle‐aged women, age, menopause, weight gain, onset of depression and impaired health‐related quality of life may promote UI.
Objectives
To evaluate the impact of preoperative Music Therapy (MT) on pain in first‐trimester termination of pregnancy (TOP) under local anaesthesia.
Design
Randomised controlled trial comparing ...women undergoing a first‐trimester TOP under local anaesthesia with or without a preoperative MT session.
Setting
University Hospital of Angers from November 2016 to August 2017.
Population
Women who underwent first‐trimester TOP under local anaesthesia.
Methods
Women allocated to the MT group underwent a preoperative 20‐minute session of MT.
Main outcome measures
Pain was assessed using a visual analogue scale (VAS) just before the procedure, during the procedure, at the end of the procedure and upon returning to the ward.
Results
A total of 159 women were randomised (80 in the MT group, and 79 in the control group). Two women were excluded from the control group and six from the MT group. Therefore, 77 women were analysed in the control group and 74 in the MT group. The intensity of pain was similar in the two groups just before the procedure (VAS 4.0 ± 2.9 versus 3.6 ± 2.5; P = 0.78), during the procedure (VAS 5.3 ± 2.5 versus 4.9 ± 2.9; P = 0.78), at the end of the procedure (VAS 2.7 ± 2.4 versus 2.6 ± 2.4; P = 0.43) and upon returning to the ward (VAS 1.8 ± 2.0 versus 1.5 ± 2.0; P = 0.84). The difference in pain between entering the department and returning to the room after the procedure was similar between the MT and control groups (difference in VAS 0.3 ± 2.5 versus 0.3 ± 2.4; P = 0.92).
Conclusion
An MT session before a TOP under local anaesthesia procedure resulted in no improvement in patient perception of pain during a first‐trimester TOP.
Tweetable
Music therapy before first‐trimester termination of pregnancy under local anaesthesia did not improve the perception of pain.
Tweetable
Music therapy before first‐trimester termination of pregnancy under local anaesthesia did not improve the perception of pain.
In France, the number of labiaplasty increased by 57% between 2008 and 2016. To date, only one prospective study with low-power evaluated postoperative satisfaction has been performed. This ...observational prospective study aims to evaluate the motives and post-surgery satisfaction of patients who had a labiaplasty.
This observational prospective study include all patients over 18 years old operate at the hospital of Angers during an 18-month period. The exclusion criterion was a positive screening test to the Body Dysmorphic Disorder Questionnaire. Patients were interviewed by a written questionnaire on the day of the surgery and by phone 3 and 6 months after the surgery.
A total of thirty patients were included in the study, with an average age of 31.5 (± 10.58). Twenty-three patients answered 3 months after and 19 answered 6 months after. Eighteen patients (95%) expressed satisfaction at 6 months and 16 (84%) "extremely" satisfied. Functional discomfort improved in 18 patients (94%) at 6 months. Eighty-four percent have felt an improvement regarding esthetical discomfort. All patients would recommend the surgery. The main motive was the discomfort when getting dressed for 27 patients (90%).
The patients expressed a real functional discomfort and are mostly very satisfied with their surgery at 3 and 6 months after.
The frequency of posterior presentations (occiput of the fetus towards the sacrum of the mother) in labor is approximately 20% and, of this, 5% remain posterior until the end of labor. These ...posterior presentations are associated with higher rates of cesarean section and instrumental delivery. Manual rotation of a posterior position in order to rotate the fetus to an anterior position has been proposed in order to reduce the rate of instrumental fetal delivery. No randomized study has compared the efficacy of this procedure to expectant management. We therefore propose a monocentric, interventional, randomized, prospective study to show the superiority of vaginal delivery rates using the manual rotation of the posterior position at full dilation over expectant management.
Ultrasound imaging of the presentation will be performed at full dilation on all the singleton pregnancies for which a clinical suspicion of a posterior position was raised at more than 37 weeks' gestation (WG). In the event of an ultrasound confirming a posterior position, the patient will be randomized into an experimental group (manual rotation) or a control group (expectative management with no rotation). For a power of 90% and the hypothesis that vaginal deliveries will increase by 20%, (10% of patients lost to follow-up) 238 patients will need to be included in the study. The primary endpoint will be the rate of spontaneous vaginal deliveries (expected rate without rotation: 60%). The secondary endpoints will be the rate of fetal extractions (cesarean or instrumental) and the maternal and fetal morbidity and mortality rates. The intent-to-treat study will be conducted over 24 months. Recruitment started in February 2017. To achieve the primary objective, we will perform a test comparing the number of spontaneous vaginal deliveries in the two groups using Pearson's chi-squared test (provided that the conditions for using this test are satisfactory in terms of numbers). In the event that this test cannot be performed, we will use Fisher's exact test.
Given that the efficacy of manual rotation has not been proven with a high level of evidence, the practice of this technique is not systematically recommended by scholarly societies and is, therefore, rarely performed by obstetric gynecologists. If our hypothesis regarding the superiority of manual rotation is confirmed, our study will help change delivery practices in cases of posterior fetal position. An increase in the rates of vaginal delivery will help decrease the short- and long-term rates of morbidity and mortality following cesarean section. Manual rotation is a simple and effective method with a success rate of almost 90%. Several preliminary studies have shown that manual rotation is associated with reduced rates for fetal extraction and maternal complications: Shaffer has shown that the cesarean section rate is lower in patients for whom a manual rotation is performed successfully (2%) with a 9% rate of cesarean sections when manual rotation is performed versus 41% when it is not performed. Le Ray has shown that manual rotation significantly reduces vaginal delivery rates via fetal extraction (23.2% vs 38.7%, p < 0.01). However, manual rotation is not systematically performed due to the absence of proof of its efficacy in retrospective studies and quasi-experimental before/after studies.
ClinicalTrials.gov, Identifier: NCT03009435 . Registered on 30 December 2016.
To provide French guidelines for the management of women with abnormal uterine bleeding (AUB).
A consensus committee of 26 experts was formed. A formal conflict-of-interest policy was developed at ...the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding (i.e. pharmaceutical or medical device companies). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized.
The last guidelines from the Collège National des Gynécologues et Obstétriciens Français on the management of women with AUB were published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescents; idiopathic AUB; endometrial hyperplasia and polyps; type 0–2 fibroids; type 3 or higher fibroids; and adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and evidence profiles were compiled. The GRADE® methodology was applied to the literature review and the formulation of recommendations.
The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 are strong and 17 weak. No response was found in the literature for 14 questions. We chose to abstain from recommendations rather than providing advice based solely on expert clinical experience.
The 36 recommendations make it possible to specify the diagnostic and therapeutic strategies for various clinical situations practitioners encounter, from the simplest to the most complex.
The learning curve cumulative summation test (LC CUSUM test) allows to define an individualized learning curve and determine the moment when clinical proficiency is attained. After acquisition of the ...skills, the cumulative summation test (CUSUM test) allows to monitor the maintenance of the required level over time. The LC CUSUM test has been frequently used in the field of Obstetrics and Gynecology (Ob/Gyn) for several procedures, but only once for OR.
We performed a retrospective study at Angers university hospital between May 2017 and September 2018. Seven Ob/Gyn residents and 5 senior physicians were included, and all OR performed during that time (n = 690) were analyzed. The performance index assessed was the oocyte retrieval rate (ORR), defined as the ratio of oocytes retrieved to follicles aspirated. We used the LC CUSUM test to analyze the learning curves of residents, and the CUSUM test to monitor the performance of senior physicians. An ORR ≥50% in 60% of retrievals was defined as the threshold for clinical proficiency.
Six hundred seventy-four oocyte retrieval (OR) were included: 315 were performed by residents, 220 by senior physicians, and 139 by both residents and physicians (mixed retrievals). Four residents (57%) reached the threshold after aspirating 82, 67, 53 and 46 ovaries, respectively. The mean number of ovaries aspirated in order to reach clinical proficiency was 62, and the mean number of weeks needed was 21. The duration of the learning period varied between 26 and 80 days. Two senior physicians (40%) remained proficient across the duration of the study, while two physicians (40%) had one statistically "suboptimal" OR, and one physician (20%) had two suboptimal retrievals.
There is a large variability in the duration of the learning period and the number of procedures needed for a resident to master OR. Senior physicians maintain an adequate performance.
Sea surface temperature (SST) can be estimated from day and night observations of the Spinning Enhanced Visible and Infra-Red Imager (SEVIRI) by optimal estimation (OE). We show that exploiting the ...8.7μm channel, in addition to the “traditional” wavelengths of 10.8 and 12.0μm, improves OE SST retrieval statistics in validation. However, the main benefit is an improvement in the sensitivity of the SST estimate to variability in true SST.
In a fair, single-pixel comparison, the 3-channel OE gives better results than the SST estimation technique presently operational within the Ocean and Sea Ice Satellite Application Facility. This operational technique is to use SST retrieval coefficients, followed by a bias-correction step informed by radiative transfer simulation. However, the operational technique has an additional “atmospheric correction smoothing”, which improves its noise performance, and hitherto had no analogue within the OE framework. Here, we propose an analogue to atmospheric correction smoothing, based on the expectation that atmospheric total column water vapour has a longer spatial correlation length scale than SST features. The approach extends the observations input to the OE to include the averaged brightness temperatures (BTs) of nearby clear-sky pixels, in addition to the BTs of the pixel for which SST is being retrieved. The retrieved quantities are then the single-pixel SST and the clear-sky total column water vapour averaged over the vicinity of the pixel. This reduces the noise in the retrieved SST significantly. The robust standard deviation of the new OE SST compared to matched drifting buoys becomes 0.39K for all data. The smoothed OE gives SST sensitivity of 98% on average. This means that diurnal temperature variability and ocean frontal gradients are more faithfully estimated, and that the influence of the prior SST used is minimal (2%). This benefit is not available using traditional atmospheric correction smoothing.
► Sea surface temperature retrieved from SEVIRI by optimal estimation. ► Use of 8.7μm channel with 11 and 12μm improves sensitivity. ► Novel method for accounting for spatial correlation of atmospheric effects proposed. ► Simultaneous reduction in noise and improvement in sensitivity obtained. ► Sensitivity shown to be important in observing diurnal cycle of sea surface temperature.
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