Transrectal high-intensity focused ultrasound (HIFU) for management of rectosigmoid deep infiltrating endometriosis: results of Phase-I clinical trial.

OBJECTIVES: Deep infiltrating endometriosis (DIE) of the rectosigmoid is associated with painful symptoms. When medical treatment is ineffective, surgical resection remains the standard treatment, despite significant risk of adverse events. High-intensity focused ultrasound (HIFU) is a minimally invasive ablative procedure. Focal One® is a transrectal HIFU (TR-HIFU) device used in prostate cancer treatment. The primary objective of this study was to confirm the feasibility of treatment with TR-HIFU in patients presenting with posterior DIE with rectosigmoid involvement. We also assessed its safety and clinical efficacy in this context. METHODS: This was a non-controlled, prospective, Phase-I clinical trial in a French University Hospital which is a multidisciplinary center for management of endometriosis. Included were patients older than 25 years, without plans to conceive within 6 months, who presented with a single lesion of posterior DIE, with rectosigmoid invasion, after failure of hormonal therapy. All lesions were assessed preoperatively using transvaginal sonography and magnetic resonance imaging. Patients completed questionnaires on gynecological and intestinal symptoms (similar to a visual analog scale (VAS)), and on quality of life (Medical Outcomes Study 36-item short-form survey (SF-36) and, for the second half of patients recruited, symptom scoring system for constipation (KESS), female sexual function index (FSFI) and endometriosis health profile short-version score (EHP-5)), before, and at 1, 3 and 6 months after, TR-HIFU treatment with a Focal One real-time ultrasound-guided HIFU device. RESULTS: Twenty-three consecutive patients were included in the study between September 2015 and October 2019. All 23 lesions were visualized, giving a detection rate of 100%. Twenty lesions were treated ('feasibility rate', 87.0%): in 13 the whole lesion was treated and in seven the lesion was treated partially. The mean duration of the TR-HIFU procedure was 55.6 min. We observed a significant improvement in VAS score at 6 months, with differences relative to preoperative scores as follows, for: dysmenorrhea (-3.6, P = 0.004), dyspareunia (-2.4, P = 0.006), diarrhea (-3.0, P = 0.006), constipation (-3.0, P = 0.002), dyschezia (-3.2, P = 0.003), false urge to defecate (-3.3, P = 0.007), posterior pelvic pain (-3.8, P = 0.002) and asthenia (-3.8, P = 0.002). There was also a significant improvement in the SF-36 score, with an increase at 6 months relative to the preoperative score in both the physical component summary (+ 9.3%, P = 0.002) and mental component summary (+ 10.9%, P = 0.017). No major complications occurred during or after any procedure. CONCLUSIONS: TR-HIFU therapy for posterior DIE is feasible. If its efficacy and safety are confirmed, it could be a minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis. © 2019 Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Surgical management of a loss of pregnancy in the first trimester: Patient experience and influencing factors, a prospective observational study.

OBJECTIVE: Describe the "patient experience" regarding care provided during the surgical management of a loss of pregnancy in the first trimester and identify the factors influencing this experience. MATERIAL AND METHODS: It is an observational prospective study conducted in two type III, academic, maternity wards in Lyon, France, carrying out 8,500 deliveries per year. Adult female patients, having undergone a suction curettage for a loss of pregnancy in the first trimester from 24 December 2020 to 13 June 2021 were inculded. The "patient experience" was assessed using the 15 questions of the Picker Patient Experience (PPE-15) questionnaire, and research was conducted on factors influencing the patient experience. The main outcome was the percentage of patients reporting a problem in response to at least one of the PPE-15 questions. RESULTS: 58 out of 79 patients (73% CI [62-83]) reported at least one problem with their care. The largest proportion of problems was raised in question about "Opportunity for family/loved ones to talk to the doctor" (76% CI [61-87]). The lowest proportion of problems was raised in question about "Treated with respect and dignity" (8% CI [3-16]). No factors influencing the patient experience were identified. DISCUSSION: Almost three out of four patients reported a problem in the experience as a patient. The main areas of improvement reported by patients were the participation of their family/relatives and the emotional support provided by the healthcare team. TWEETABLE ABSTRACT: Better communication with patient families and emotional support could improve patient experience during the surgical management of a loss of pregnancy in the first trimester.

[How is our practice of mastectomy? Analysis based on population data in a French department]. / Quelles évolutions dans notre pratique de la mastectomie ? Analyse à partir de données de population dans un département français.

OBJECTIVE: The objective of this research was to study the evolution of the mastectomy rate in patients with breast cancer between 1998 and 2015, based on population data from the Côte d'Or breast cancer registry of the FRANCIM network ("France cancer incidence and mortality"). METHODS: In this study on population register we included patients who had presented a primary breast cancer (invasive cancer and/or carcinoma in situ [CIS]) between 1998 and 2015 in the Côte d'Or department. We estimated the annual proportions of mastectomies, then calculated their evolution trends over this period. RESULTS: Between 1998 and 2015, 7093 patients were included. The overall proportion of mastectomies was stable at 28% and did not respond to a time trend (Sen's slope of 0.2% per year; P=0.289). There was an increase in the proportion of lobular carcinomas (slope at 0.3% per year; P <0.05), with a rising proportion of mastectomy for lobular carcinomas (slope at 0.6% per year; P<0.05) but decreasing for ductal (slope at -0.8% per year; P<0.05). The proportion of mastectomy was stable for plurifocal cancers but the proportion of plurifocal cancers increased over time (slope at 0.8% per year; P<0.05). CONCLUSION: Therefore, mastectomy remained a stable practice over the 18 years of analysis in the Côte d'Or region. However, this overall stability is the result of variations in the profiles of diagnosed cancers and surgical practices.

The psychological impact of therapeutic changes during the COVID-19-lockdown for gynaecological and breast cancer patients.

OBJECTIVE: The exceptional health situation related to the Coronavirus 2019 (COVID-19) pandemic has required an in-depth and immediate reorganisation of gynaecological cancer care. The main objective was to assess the psychological impact of such treatment modifications during the lockdown period for gynaecological and breast cancer patients. PATIENTS AND METHODS: A multicentre prospective study was conducted in three university gynaecological cancer wards (Hospices Civils de Lyon, France) during the French first lockdown (16th March to 11th May 2020). All patients with non-metastatic breast cancer or gynaecological cancer were included. Data was collected regarding treatment modifications (delay, cancellation, change of therapeutic plan). The psychological impact of treatment modifications during and after the lockdown was assessed by validated questionnaires (SF-12, EORTC-QLQ-C30, HADS). RESULTS: A total of 205 consecutive patients were included, aged 60.5 ± 1.0 years. Seven patients (3.4%) presented a SARS-CoV-2 infection, and two patients died. Treatment was maintained for 122 (59.5%) patients, postponed for 72 (35.1%) and cancelled for 11 (5.4%). During the lockdown, 35/118 (29.7%) patients suffered from confirmed anxiety and the mean fatigue-EORTC score was 48.00 ± 2.51; it was 38.64 ± 2.33 (p = 0.02) after the lockdown. After the lockdown and compared to the lockdown period, the mental SF-12 score and overall health status EORTC score were significantly higher (45.03 ± 1.06 vs 41.71 ± 1.15, p = 0.02 and 64.58 ± 1.66 vs 57.44 ± 2.02, p = 0.0007, respectively). The number of confirmed-anxiety cases was significantly higher amongst patients for whom treatment was delayed or cancelled (40.5% vs 23.7%, p = 0.04). CONCLUSION: This study quantified the treatment modifications of gynaecological cancer patients during the COVID-19 lockdown and revealed a poorer psychological state and quality of life during this period, even for patients whose treatment plan was not actually modified. Anxiety was more significant in patients with a delayed or cancelled treatment.

[Performances and place of sonography in the diagnostic of endometriosis: CNGOF-HAS Endometriosis Guidelines]. / Performances et place de l'échographie dans le diagnostic de l'endométriose, RPC Endométriose CNGOF­HAS.

Endometriosis is difficult to diagnose clinically. Transvaginal sonography (TVS) is a procedure that is known to be operator-dependent, which mean that published evidences has to be balanced with the level of the sonographer that produced the data. The objective of this publication was to assess the performances of the sonography in the diagnosis of endometriosis in order to establish the French national recommendations. We searched the MEDLINE database for publication from January 2000 to September 2017 using keywords associated with endometriosis and sonography. Eighty-four trial and reviews published in English or French were included. Ovarian endometrioma can usually be diagnosed by a non-expert sonographer, especially when its aspect is typical. In case of an ovarian cyst with atypical presentation, it is recommended to control the sonography by a referent or to perform an MRI. In menopaused women, any ovarian cyst should be considered as a cancer until proven otherwise. In the diagnosis of posterior deep invasive endometriosis (DIE), TVS with sensitivity and specificity of 96 and 99% respectively, seems at least equivalent if not superior to MRI. However, these performances are related to expert sonographers. To reach sufficient efficiency in posterior DIE, the estimated learning curve for a sonographer is 44 cases. When posterior DIE is suspected, we recommend proposing a TVS "performed by an expert" or a MRI "at least interpreted by an expert". In anterior DIE, TVS has a good specificity (100%), but its sensitivity is poor in the literature (64%). TVS is therefore not able to eliminate the diagnosis. However a renal ultrasound should be proposed each time a urinary endometriosis is confirmed, and should be considered whenever posterior DIE is diagnosed especially the lesion is superior to 3cm.

[Fetal heart rate analysis: Evaluation of an in situ training program on cardiotocography interpretation during labor in the Auvergne-Rhône-Alpes region (France)]. / Formation à l'analyse du rythme cardiaque fœtal : évaluation d'un programme d'enseignement in situ au sein du réseau périnatal Auvergne-Rhône-Alpes.

OBJECTIVES: To evaluate an in situ training program on caradiotocography interpretation during labor in the Auvergne-Rhône-Alpes region (France). METHODS: Fifteen hospital maternity unit took part to an "outreach visit" training on fetal cardiotocography interpretation between November 2011 and 2015. Professionals were asked to answer to a 10 questions test based on the French classification of fetal heart rate, at inclusion (Test 0: T0), immediately after (Test 1: T1), and long time after the training (Test 2: T2). The mean score for each maternity (T0, T1, T2) was compared individually. Subgroup analysis considered the level of perinatal care of each maternity (level 1 or 2) and the type of practice (public or private). RESULTS: The study included 332 healthcare professionals belonging to 8 level 1 (53.5%) and 7 level 2 (47.7%) maternity units. The T0 mean score was 4.79 (IC 95% [4.54; 5.02]) instead of 6.71(IC 95% [6.49; 6.93]) at T1 (P<0.05). Seventeen professionals (22.9%) answered T2 with a mean time of 35.2 months (Median value: 40 months) and a mean score of 5.32. The mean score was significantly higher at T2 than at T0 (5.32-IC 95%[4.94-5.70] (P<0.001) but lower than the score at T1 (P<0.05). CONCLUSION: An "outreach visit" training on fetal cardiotocography interpretation improves theknowledge of healthcare professionals at short and long term.

[Epidemiology and diagnosis strategy: CNGOF-HAS Endometriosis Guidelines]. / Épidémiologie et stratégie diagnostique, RPC Endométriose CNGOF­HAS.

Based on the best evidence available, we have provided guidelines for clinical practice to target the nature of endometriosis as a disease, the consequences of its natural history on management, and the clinical and imaging evaluation of the disease according to the level of care (primary care, specialized or referral). The frequency of endometriosis is unknown in the general population; endometriosis requires management when it causes symptoms (pain, infertility) or when it affect the function of an organ. In the absence of symptom, there is no need for follow-up or screening of the disease. Endometriosis may be responsible for various pain symptoms such as severe dysmenorrhea, deep dyspareunia, painful bowel movements or low urinary tract signs increasing with menstruation, or infertility. A careful evaluation of the symptoms and their impact on the quality of life should be made. The first-line examinations for the diagnosis of endometriosis are: digital examination and pelvic ultrasound. The second-line examinations are: the pelvic exam by an expert clinician, the pelvic MRI and/or the transvaginal ultrasound by an expert. MRI and ultrasound carrying different and complementary information. Other examinations may be considered as part of the pre-therapeutic assessment of the disease in case of specialized care. Diagnostic laparoscopy may be suggested in case of clinical suspicion of endometriosis whereas preoperative examinations have not proved the disease, it must be part of a management plan of endometriosis-related pain or infertility. During management, it is recommended to give comprehensive information on the different therapeutic alternatives, the benefits and risks expected from each treatment, the risk of recurrence, fertility, especially before surgery. The information must be personalized and take into account the expectations and preferences of the patient, and accompanied by an information notice given to the patient.

Management of endometriosis: CNGOF/HAS clinical practice guidelines - Short version.

First-line diagnostic investigations for endometriosis are physical examination and pelvic ultrasound. The second-line investigations are: targeted pelvic examination performed by an expert clinician, transvaginal ultrasound performed by an expert physician sonographer (radiologist or gynaecologist), and pelvic MRI. Management of endometriosis is recommended when the disease has a functional impact. Recommended first-line hormonal therapies for the management of endometriosis-related pain are combined hormonal contraceptives (CHCs) or the 52mg levonorgestrel-releasing intrauterine system (IUS). There is no evidence base on which to recommend systematic preoperative hormonal therapy solely to prevent surgical complications or facilitate surgery. After surgery for endometriosis, a CHC or 52mg levonorgestrel-releasing IUS is recommended as first-line treatment when pregnancy is not desired. In the event of failure of the initial treatment, recurrence, or multiorgan involvement, a multidisciplinary team meeting is recommended, involving physicians, surgeons and other professionals. A laparoscopic approach is recommended for surgical treatment of endometriosis. HRT can be offered to postmenopausal women who have undergone surgical treatment for endometriosis. Antigonadotrophic hormonal therapy is not recommended for patients with endometriosis and infertility to increase the chances of spontaneous pregnancy, including postoperatively. Fertility preservation options must be discussed with patients undergoing surgery for ovarian endometriomas.

[Management of endometriosis: CNGOF-HAS practice guidelines (short version)]. / Prise en charge de l'endométriose : recommandations pour la pratique clinique CNGOF-HAS (texte court).

First-line investigations to diagnose endometriosis are clinical examination and pelvic ultrasound. Second-line investigations include pelvic examination performed by a referent clinician, transvaginal ultrasound performed by a referent echographist, and pelvic MRI. It is recommended to treat endometriosis when it is symptomatic. First-line hormonal treatments recommended for the management of painful endometriosis are combined with hormonal contraceptives or levonorgestrel 52mg IUD. There is no evidence to recommend systematic preoperative hormonal therapy for the unique purpose of preventing the risk of surgical complications or facilitating surgery. After endometriosis surgery, combined hormonal contraceptives or levonorgestrel SIU 52mg are recommended as first-line therapy in the absence of desire of pregnancy. In case of initial treatment failure, recurrence, or multiple organ involvement by endometriosis, medico-surgical and multidisciplinary discussion is recommended. The laparoscopic approach is recommended for the surgical treatment of endometriosis. HRT may be offered in postmenopausal women operated for endometriosis. In case of infertility related to endometriosis, it is not recommended to prescribe anti-gonadotropic hormone therapy to increase the rate of spontaneous pregnancy, including postoperatively. The possibilities of fertility preservation should be discussed with the patient in case of surgery for ovarian endometrioma.

[Cesarean scar ectopic pregnancies: combined modality therapies with uterine artery embolization before surgical procedure]. / Grossesse sur cicatrice de césarienne : traitement combiné avec embolisation des artères utérines avant procédure chirurgicale.

OBJECTIVES: To offer a therapeutic management of cesarean scar pregnancies (GSC) in the first trimester of pregnancy with a first approach by uterine artery embolization (UAE) PATIENTS AND METHODS: This study describes seven cases of GSC diagnosed between 2009 and 2013 in the clinic of the University Hospital of the Hospital of Croix-Rousse. We present the symptoms and how imagery has led to the diagnosis and the therapeutic management conducted. RESULTS: The mean gestational age at diagnosis was 9 weeks gestation. There were ongoing pregnancies with cardiac activity present for each patient. An additional MRI was performed in five patients. Five patients were treated with methotrexate injection, two patients received the Mifegyne. All patients then received a selective uterine artery embolization. Finally within 48hours, suction curettage was performed in 6 patients. A patient at 13 WA+1 required a subtotal hysterectomy for placenta accreta. Intra-operative complications were represented by a bladder injury, two bleeding of 1000mL in patients at 13 WA+1 and 12 WA. For the 6 cases of GSC with a gestational age less than 10 WA, average blood loss was less than 500mL. Three patients underwent resection of scar isthmocele confirmed by EVAC. An intrauterine pregnancy was carried to term after care. DISCUSSION AND CONCLUSION: Cesarean scar pregnancies is a diagnostic and therapeutic challenge, which should be diagnosed as early as soon as possible with care in a medical facility with a uterine artery embolization technical platform. Our protocol combining Mifegyne and methotrexate for termination of pregnancy and uterine artery embolization (UAE) followed by curettage for evacuation of pregnancy allows conservative treatment while minimizing the risk of bleeding (for GSC diagnosed before 10 WA).

[Hysteroscopic septoplasty: after miscarriages?]. / Faut-il attendre les accidents obstétricaux pour sectionner les cloisons utérines ?

OBJECTIVE: To assess reproductive outcome of women affected by septate uterus after surgical correction. PATIENTS AND METHODS: It is a retrospective study. The setting is a French university hospital. Surgery was performed on 66 patients between 2000 and 2010. Hysteroscopic metroplasty was performed in every group once the diagnosis was made. There were two groups: 35 patients affected by septate uterus had past history of miscarriages, preterm and term deliveries. Thirty-six patients had never been pregnant. RESULTS: In the group of 35 patients with a previous obstetric history, the rate of miscarriages was 57.1% before surgery and 10% after surgery. There was a significant gain of live birth ratio of 55% among women being pregnant after surgery compared to women being pregnant before surgery. For patients with no pregnancy before surgery, obstetrical results are the following ones: miscarriages 25.9%, preterm deliveries 11% and term deliveries 59.3%. DISCUSSION AND CONCLUSION: Hysteroscopic septoplasty is an easy technique with few complications in our study. Hysteroscopic septoplasty is strongly recommended after recurrent miscarriages or premature deliveries. We use to propose surgery to every patient affected by septate uterus, even if they have never been pregnant.