Validation of the Sexual Activity Questionnaire in women with endometriosis.

STUDY QUESTION: Is the Sexual Activity Questionnaire (SAQ) a valid tool for patients treated for symptomatic endometriosis? SUMMARY ANSWER: For women having surgical treatment for endometriosis, we determined that the SAQ is a valid and responsive tool. WHAT IS KNOWN ALREADY: Endometriosis adversely affects sexual quality of life. Suitable validated sexual quality of life instruments for endometriosis are lacking both in clinical practice and for research. STUDY, DESIGN, SIZE, DURATION: A total of 367 women with proven endometriosis undergoing medical or surgical treatment were included in an observational study conducted between 1 January 2012 and 31 December 2014 in two French tertiary care centers. Both hospitals are reference centers for endometriosis treatment. Of these 367 women, 267 were sexually active and constituted the baseline population. PARTICPANTS/MATERIALS, SETTINGS, METHODS: Women >18 years old with histological or radiological proven endometriosis, consulting for painful symptoms of at least 3 months duration, infertility, or other symptoms (bleeding, cysts) were invited to complete self-administered questionnaires before (T0) and 12 months after treatment (T1). Tests of data quality included descriptive statistics of the data, missing data levels, floor and ceiling effects, structural validity and internal consistency.The construct validity was obtained by testing presupposed relationships between previously established SAQ scores and prespecified characteristics of the patients by comparing different subgroups of patients at T0. Sensitivity to change was subsequently calculated by comparing the SAQ score between T1 and T0 overall and for different subgroups of treatment. Effect sizes (to T1) were calculated according to Cohen's method. The minimally important difference was estimated by a step-wise triangulation approach (including anchor-based method). MAIN RESULTS AND THE ROLE OF CHANCE: In total, 267 sexually active patients (204 surgical and 63 medical treatment) completed the SAQ at T0 and 136 (50.9%) at T1. The SAQ score ranged from 2.0 to 28.0 (mean ± SD: 16.8 ± 5.7).The SAQ score was one-dimensional according to the scree plot with good internal consistency (Cronbach alpha = 0.78, 95% CI 0.74-0.81) and had good discriminative ability according to pain descriptors and quality of life in endometriosis. The SAQ was responsive in patients treated by surgery but the effect size was low (0.3, 95% CI (0.0-0.6), P = 0.01). The minimally important difference was determined at 2.2. LIMITATIONS, REASONS FOR CAUTION: The effect size for medical treatment was non-significant. Other effect sizes were low but statistically significant. This could be explained by lower libido due to progestin intake, which was used for both surgically and medically treated patients. WIDER IMPLICATIONS OF THE FINDINGS: The SAQ is easy to use, valid and effective in assessing sexual quality of life in patients with endometriosis. This patient-reported score could be used as a primary outcome for future clinical studies. The minimally important difference estimation will be useful for future research. We recommend using 2.2 for the minimally important difference of the SAQ. STUDY FUNDING/COMPETING INTEREST(S): This work was funded by the 'Direction à la Recherche Clinique et à l'Innovation' of Versailles, France and the 'Institut de Recherche en Santé de la Femme' (IRSF). The authors have no conflicts of interest to declare.

Massive hemoperitoneum due to uterine perforation by the Bakri Balloon, during the treatment of postpartum hemorrhage.

The current case describes a very rare complication of Bakri Balloon during the treatment of postpartum hemorrhage; a massive hemoperitoneum with a hemodynamic shock, due to a migration through the right broad ligament, with an anterior uterine rupture, and an irreversible wound of the right uterine artery. This event occurred even if the unfold placement was controlled with ultrasound guidance, to a patient who has never had abdominal surgery (Cesarean section included).

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.

Hysteroscopic resection on virtual reality simulator: What do we measure?

OBJECTIVE: The objective was to compare results of two groups of population (novices and experts) on a virtual reality simulator of hysteroscopy resection for different metrics and for a multimetric score to assess its construct validity. MATERIALS AND METHODS: Nineteen gynecologist who had at least 5 years of experience with hysteroscopy and self-evaluated their expertise at 4/5 or 5/5 were included as expert population. Twenty first-year gynecology residents in Paris were included as novice population. A standardized set of 4 hysteroscopy resection cases (polypectomy, myomectomy, roller ball endometrial ablation and septum resection) was performed on a virtual reality simulator (HystSim™) by the group of novices and experts. Results obtained on the simulator for overall score and for the parameters were compared by applying the Mann-Whitney test. RESULTS: Overall score of novices and experts were significantly different for three resection cases (polypectomy P<0.001, myomectomy P<0.001, roller ball endometrial ablation <0.001). The overall score was not different in the septum resection (P=0.456). For the four cases, the economy score (included cumulative path length, procedure time and camera alignment) were statistically different between novices and experts (polypectomy P<0.001, myomectomy P=0.001, roller ball endometrial ablation P<0.001, septum resection P<0.001). CONCLUSION: The overall score on HystSim™ was able to discriminate novices between experts on polypectomy, myomectomy and roller ball endometrial ablation cases but not on septum resection. The economy score was the more reliable to reflect the surgeon experience. It could be used to evaluate and to train students on hysteroscopic resection on a virtual reality simulator.

The definition of Endometriosis Expert Centres.

Endometriosis is a common condition that causes pain and infertility. It can lead to absenteeism and also to multiple surgeries with a consequent risk of impaired fertility, and constitutes a major public health cost. Despite the existence of numerous national and international guidelines, the management of endometriosis remains suboptimal. To address this issue, the French College of Gynaecologists and Obstetricians (CNGOF) and the Society of Gynaecological and Pelvic Surgery (SCGP) convened a committee of experts tasked with defining the criteria for establishing a system of care networks, headed by Expert Centres, covering all of mainland France and its overseas territories. This document sets out the criteria for the designation of Expert Centres. It will serve as a guide for the authorities concerned, to ensure that the means are provided to adequately manage patients with endometriosis.

Reproducibility of the interpretation of coronal 3D ultrasound view of the uterus to evaluate the position of Essure® 3 months after hysteroscopic procedure.

OBJECTIVE: Three-dimensional sonography is a good alternative method to assess the position of microinserts. Adequate position after three months allows for the interruption of other contraception. Objective is to evaluate inter-observer reproducibility of the interpretation of coronal transvaginal 3D ultrasound view of the uterus to evaluate the position of Essure®. STUDY DESIGN: Inter-observer reproducibility study. Fifty women underwent successful bilateral placement of microinserts (Essure®) by hysteroscopy in the Department of Gynaecology of a teaching hospital and were included in the study. At three month, 3D ultrasound coronal views of the fifty uterus (accounting for one hundred microinserts) were assessed by five different observers and microinsert position was classified according to the classification described by Legendre et al. Inter-observer reproducibility in reading the 3D coronal view of the uterus was evaluated. RESULTS: The k-value was disparate, from 0.26 to 0.82. Inter-observer reproducibility then ranged from fair to almost perfect, depending on a prior knowledge of the position classification. CONCLUSIONS: Transvaginal 3D coronal view of the uterus is sufficient to assess the positioning of the microinserts when the practionner or the surgeon is familiar with the classification method.

Assessing technical competence in laparoscopic surgery in France: Ratification of the GOALS rating scale.

BACKGROUND: The question of assessing surgical competence is the focus of mainly Anglo-Saxon studies. The GOALS questionnaire (Global Operative Assessment of Laparoscopic Skills) specific to laparoscopic surgery assessment has been developed since 2005. The aim of the study was to assess the metrological qualities of the GOALS questionnaire after ratification in French language. METHODS: To produce a French version of the GOALS surgical competence assessing tool according to an established method (translation - backward translation - retranslation) and to check the metrological qualities (user satisfaction, acceptability, reliability and validity) of this questionnaire through observing residents while in training program on 22 residents in Gynaecology Obstetrics during the laparoscopy training, with the performance of a nephrectomy on a porcine model. RESULTS: The discrepancies in the initial translations were mainly due literal translations. Only synonymous differences were observed in the two backward translations. Comparison with original version led to 8 minor changes. No changes occurred between the 2 French versions. Satisfaction surveys when using the GOALS questionnaire by both examiners and students are similar. Face and content validity seemed good and there is no significant discrepancy between the examiners and the students (11.5 [9-15]; 12.4 [9-15]; P=0.40). Assessment by examiners showed an median value of 17.8 [9-26] with good correlation (α=0.80). By contrast, self-assessment, although there is no significant discrepancy, showed heterogeneity. GOALS French version was able to prove a significant progression both in self-assessment and external evaluation between the act performed on the first nephrectomy on the first day of the first session of the training and the fourth nephrectomy performed on the first day of the second session of the training. CONCLUSION: Our work allowed obtaining a GOALS French version with acceptable validity, good consistency between the assessments and ability to measure progress.

Glue mesh fixation: Feasibility, tolerance and complication assessment. Results 24months after laparoscopic sacrocolpopexy.

AIM: This study aims to assess short- and mid-term feasibility, strength and tolerance of glue mesh fixation for laparoscopic sacrocolpopexy, as well as postoperative quality of sexual activity. PATIENTS AND METHODS: This original prospective clinical study was carried out in multiple university surgical centres between 2012 and 2013. Data were obtained during immediate postoperative hospitalisation, at 3 and at 24 months postoperatively. For a total of 42 patients subjected to laparoscopic sacrocolpopexy, bladder catheterization and hospitalisation times, pain score, early and late postoperative complications, prolapse staging according to POP-Q classification, and quality of sexual activity were registered. RESULTS: Mean operative time was 120minutes and patients were hospitalised for a mean of 3days. Four complications (9.52%) occurred on the immediate postoperative period, whilst 2 patients (4.76%) complained of pain on day 3 (VAS 1). At the end of the follow-up period (24 months), one patient had a prosthetic exposure, 4 patients (9.52%) complained of stress urinary incontinence (10.81%). Simultaneously, 6 patients (14.29%) experienced dyschezia (2 improved, 1 similar, 1 de novo, 2 worsened), and there was no report of dyspareunia. All anterior and posterior floor prolapses were staged between 0 and 1. All superior floor prolapses were staged between 0 and 2. Concerning sexual impairment, there was no report of dyspareunia, urinary leaks or other problems associated with intercourse, and quality of sexual activity improved. CONCLUSION: Minimally invasive sacrocolpopexy with the use of glue fixation does not lead to increased mid-term morbidity, simultaneously allowing for significant prolapse improvement, and providing global patient satisfaction and overall quality of life.

[Analysis from the French DRG-based information system (PMSI) of conservative surgical treatment for abnormal uterine bleeding in 2008-2010]. / Analyse des traitements chirurgicaux conservateurs des pathologies de l'endomètre en France de 2008 à 2010 dans les établissements de santé. Analyse des données du programme médicalisé des systèmes d'information (PMSI).

OBJECTIVE: To evaluate the conservative surgical treatment for abnormal uterine bleeding from the Medicalized Information System Program (PMSI). MATERIALS AND METHODS: The diagnosis codes were selected from 10th version of the international classification disease. A transversal and longitudinal descriptive analysis was performed from hospital stays, patient's characteristics, medical procedures between 2008-2010. RESULTS: Nineteen thousand six hundred and seventy-nine patients were admitted in hospital (public or private) for treatment of abnormal uterine bleeding. Endometrial ablation increased by 16,7%, 10.2% for first generation technique (G1) and 63.5% for second generation techniques (G2). G2 were used in 15% of indications. The median age was respectively 45.2±6.4 years old versus 45.8±4.9 years old for G2. The median length of hospital stay was 1.6 ±1with 69% of patients in ambulatory care. The likelihood to have a hysterectomy in the 3 years follow-up was higher after G1 than G2 treatments (P=0.0034) for the patients above 40 years old. In longitudinal study, defined only by endometrial hyperplasia, 11,532 patients were included and only 8.2% had been treated by G2. CONCLUSION: In spite of the international guidelines since 2008, 85% of patients treated with first generation surgical technique. The failure rate defined by a re-ablation or a hysterectomy is higher after G1. This result must be discussed in relationship with cost effective aspects.

Endometriotic lesions of the lower troncular nerves.

Although exceptional, endometriotic lesions of the troncular nerves of the lower limb may occur and are often diagnosed with delay. We report, hereby, the first case of femoral nerve endometriosis the treatment of which consisted of radical resection with femoral nerve transplant. We completed a review of the literature on sciatic nerve endometriotic lesions and discussed the physiopathology and surgical treatment.

Tubal sterilization: pregnancy rates after hysteroscopic versus laparoscopic sterilization in France, 2006-2010.

OBJECTIVE: To compare the rates of pregnancy among women who underwent Essure hysteroscopic sterilization versus tubal ligation in France between 2006 and 2010. STUDY DESIGN: Retrospective cohort study. SETTING: Hospital care in France (nationwide). Anonymised database of all hospital discharge summaries in France. PATIENTS: Recruitment was based on procedure codes in the national database of hospital discharge summaries. The study included all women who underwent tubal sterilization by Essure microinserts or by tubal ligation and subsequently were hospitalised either for all unexpected pregnancies related diagnosis (e.g., miscarriage, legal abortion, or delivery) or for pregnancies following reversal microsurgery or invitro fertilization (IVF) treatment. MEASUREMENTS AND MAIN RESULTS: During the study period, French hospitals performed 109,277 tubal sterilization procedures: 39,169 Essure sterilizations and 70,108 laparoscopic tubal ligations. The respective indication of both techniques depended on the surgeons' skill. The median age of the two populations was similar, 41 years (range 28-52) for Essure patients and 40 years (range 27-54) for those undergoing tubal ligation (p=0.42). A Cox model has been performed. Following sterilization, after adjustment on age Essure patients became pregnant at a significantly lower rate than laparoscopic ligation patients 0.36% versus 0.46%, respectively (HR=0.62 (040-096)), and their pregnancy rate of post-sterilization procedure was significantly lower (reversal microsurgeries: 0.02% versus 0.19% (p<0.001), IVF treatment: 0.08% versus 0.27%) (p<0.001). The pregnancy rates after IVF were 12.5% and 5.35%, respectively, and 0% and 11.36% after tubal repair. CONCLUSION: This nationwide study of tubal sterilization demonstrates that Essure was associated with lower rates of pregnancy versus tubal ligation.

[Evolution of symptoms and quality of life of patients after surgery of digestive endometriosis]. / Évolution des symptômes et de la qualité de vie des patientes après chirurgie de l'endométriose digestive.

OBJECTIVES: Prospective evaluation of symptoms and quality of life before and after surgical treatment of endometriosis with bowel involvement. PATIENTS AND METHODS: Changes in symptoms, sexuality and quality of life before and after surgery of 41 patients operated for bowel endometriosis at the centre hospitalier de Versailles (CHV) were assessed with a self-assessment questionnaire. Pains were assessed using five visual analog scales, symptoms using 26 questions with a four-level Likert item, sexuality using the SEXACQ, and quality of life using the EHP-5 and the EQ-5D VAS. RESULTS: Surgical treatment improves pain: VAS scores for main pain (P<0.0001), dysmenorrhea (P=0.0039), defecation pain (P=0.0312), non-cyclic pelvic pain (P=0.0002), and dyspareunia (P=0.0084). Twelve intestinal symptoms are improved, including three significantly. It also improves SEXACQ score (P=0.0068) and quality of life scores EHP-5 and EQ-5D VAS (P=0.0001 and P=0.0003 respectively). No difference was found between disk resection and segmental resection in terms of symptoms, sexuality and quality of life. Histological analysis suggests that when a segmental resection is done, the stage of the endometriosis bowel involvement is more advanced. DISCUSSION AND CONCLUSION: Surgery of bowel endometriosis improves symptoms and quality of life. When the stage of the bowel endometriosis is advanced, a segmental resection should be done. Moreover, self-assessment questionnaire used at the CHV seems an appropriate tool to evaluate functional outcome.

Essure® permanent birth control effectiveness: a seven-year survey.

Essure appears to be a safe reliable contraception. The aim of this study is to report French pregnancies after Essure hysteroscopic sterilization. This study is a retrospective national survey between January 2003 and September 2010. Data were collected in two ways: The surgeons contacted in our study were responsible for 63.4% of all Essure procedures in France. Fifty-eight cases of unintended pregnancies after Essure sterilization in France were reported during the study period. Factors associated to unintended pregnancies were patient' non compliance with follow-up (22 pregnancies, 38% of cases) and misinterpretation at the 3rd-month confirmation test (19 cases, 33%). Other causes were physician's deviation from protocol (10 cases) and undetected pre-procedure pregnancy (3 cases). Three pregnancies happened before the 3-months confirmation test. Based on the number of kits sold during the period, the estimated pregnancy rate was between 1.07 and 1.09/1000 procedure. The pregnancy risk after hysteroscopic sterilization may be reduced by improving patient education and physician knowledge concerning the 3rd month confirmation test.

[Permanent tubal hysteroscopic sterilization]. / Contraception permanente par pose hystéroscopique d'implants tubaires.

Tubal sterilization, of common practice all over the world, has had a quick spread in France since its legalization in 2001 and the income of a new hysteroscopic method. As a matter of fact, France is the second greater country for women having Essure® and the first country where Essure® method forestall surgical tubal ligation. Thus we focus on good practice and update knowledge about Essure® method.

[Management of symptomatic fibroids: role of supracervical hysterectomy and laparoscopy]. / Place de l'hystérectomie supracervicale et de l'abord cœlioscopique pour fibromes symptomatiques.

OBJECTIVE: Evaluate the relevance of supracervical hysterectomy, in particular by laparoscopy, in the treatment of symptomatic myomas. METHODS: Examination of the literature in the MEDLINE and Cochrane databases, between 1960 and 2010. RESULTS: Because of reduced or identical complications when performed in laparotomy or laparoscopy, respectively, subtotal hysterectomy is a possible alternative to total hysterectomy (grade B). In case of previous or current cervical dysplasy, total hysterectomy is preferable to subtotal hysterectomy (grade B). Conical resection of the endocervix is recommended in case of subtotal hysterectomy (grade C). There is no advantage to subtotal hysterectomy for the sole purpose of avoiding functional or sexual pelvic troubles (grade A). CONCLUSION: In case of symptomatic myomas, subtotal hysterectomy can be beneficial.