Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial.

Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.

Surgery of abdominal wall endometriosis associated with clear-cell carcinoma: Case report and review.

Abdominal wall is a rare location for endometriosis, with a reported incidence of parietal endometriosis of approximately 0.03 to 0.4%. It most often occurs in the aftermath of a caesarean section and is associated with pelvic endometriosis in only 5 to 15% of cases. Rare cases of malignant transformation have been described, mainly in the form of clear-cell tumours. We report the case of a 52-year-old patient with a history of endometriosis who presented with a retractile parietal mass at the level of her caesarean scar. Histological analysis confirmed a clear-cell adenocarcinoma (CCC). Few cases of endometriosis - associated CCC are described in the literature. A review of the literature suggests radical surgical treatment combined with adjuvant radio-chemotherapy. However, the prognosis is poor. The aim of this case report is to suggest the diagnosis of malignant transformation in the presence of a rapidly evolving parietal mass in the context of endometriosis and a history of caesarean section.

Nomogram for Predicting a Complex Ureteral Procedure in Pelvic Endometriosis Surgery.

STUDY OBJECTIVE: To develop a nomogram for predicting the type of ureteral procedure in pelvic deep endometriosis (DE) surgery (1) and to describe the factors and complications associated with the ureteral procedure (2). DESIGN: Retrospective monocentric study of 920 patients who underwent surgery for pelvic DE between June 2009 and March 2020 in the gynecologic surgery department of the Versailles Hospital Center. The main criterion was evaluation of the ureteral procedure, classified as simple (isolation of the ureter) or complex (dissection of the ureter, segmental ureteral resection, or nephroureterectomy). Postoperative complications, including ureteral stenosis and fistula formation, were tabulated. SETTING: Tertiary referral hospital and expert center in endometriosis. PATIENTS: A total of 920 patients with DE. INTERVENTIONS: Ureteral procedure during surgery for DE. MEASUREMENTS AND MAIN RESULTS: In total, 724 patients (79%) underwent a ureteral procedure, of which 307 (33%) were complex, including 17 (1.8%) segmental ureteral resections. In multivariate analysis, the predictive variables for a complex ureteral procedure were age (p = .036), a previous surgery for endometriosis (p <.01), and ureteral dilatation on magnetic resonance imaging (p <.001). The area under the curve for the model predicting a complex ureteral procedure was 0.68 (95% confidence interval, 0.60-0.71). A complex ureteral procedure was associated with a 3.5% rate of ureteral fistula (n = 15). CONCLUSION: Age, a previous surgery for endometriosis, a rectovaginal nodule size ≥30 mm, endometriotic involvement of the rectum or sigmoid, and ureteral dilatation are significantly associated with a complex ureteral procedure. Our results allowed us to build a nomogram that can be used to better inform patients, anticipate the therapeutic strategy, and optimize the modalities of postoperative surveillance.

Early identification of women with endometriosis by means of a simple patient-completed questionnaire screening tool: a diagnostic study.

OBJECTIVES: To assess the value of a self-completed questionnaire based on patients' verbal descriptors of pelvic painful symptoms to identify women with endometriosis. DESIGN: Prospective 1:2 nonmatched case-control study. SETTING: Three French endometriosis referral centers. PATIENT(S): Endometriosis cases were women aged 18-45 years with endometriosis confirmed by histology. Controls were as follows: asymptomatic women attending a gynecologic consultation for routine examination; women without evidence of endometriosis consulting for pain/infertility; and population-based controls from the same urban locations. INTERVENTION(S): All women completed the 21-item yes/no questionnaire about painful symptoms. MAIN OUTCOME MEASURE(S): The area under the receiver operating characteristic curve of the full question set model based on binary logistic regression and the diagnostic accuracy of low- and high-risk classification rules based on selected threshold of the prediction model. RESULT(S): We included 105 cases and 197 controls (45 asymptomatic consultation-based controls, 66 women without endometriosis consulting for pain/infertility, and 86 population-based controls). The full question set prediction model, including age, had an area under the receiver operating characteristic curve of 0.92 (95% confidence interval, 0.87-0.95) after internal validation. The high-risk classification rule had a specificity of 98.0% and a positive likelihood ratio of 30.5. The low-risk classification rule had a sensitivity of 98.1% and a negative likelihood ratio of 0.03. For a hypothesized pretest prevalence of 10%, the high- and low-risk prediction rules ascertained endometriosis with posttest probability rates of 77.2% and 0.3%, respectively. CONCLUSION(S): A self-completed patient-centered questionnaire can identify women at low or high risk of endometriosis with a high diagnostic accuracy and, thus, may help early identification of women with endometriosis.

The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis.

OBJECTIVES: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. METHODS: A prospective, observational, multicentre study was conducted including all women ≥18 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire's measurement properties. The minimal clinically important difference was estimated by the anchor-based method. RESULTS: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach α): (I) pain-related disability (α = 0.79), (II) painful bowel symptoms (α = 0.80), (III) dyspareunia (α = 0.83), and (IV) painful urinary tract symptoms (α = 0.77). They produced four subscores that can be summed to obtain a single score (α = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean ± SD: 46.7 ± 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10-7, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. CONCLUSIONS: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.

Infertility management according to the Endometriosis Fertility Index in patients operated for endometriosis: What is the optimal time frame?

INTRODUCTION: The Endometriosis Fertility Index (EFI) is a validated score for predicting the postoperative spontaneous pregnancy rate in patients undergoing endometriosis surgery. However, the practical use of the EFI to advise patients about postoperative fertility management is unclear. MATERIALS AND METHODS: All patients participating in the ENDOQUAL study-a prospective observational bi-center cohort study conducted between 01/2012 and 06/2018-who underwent surgery for infertility were asked to complete a questionnaire collecting time and mode of conception. Statistical analysis was performed with the Fine and Gray model of competing risks and analysis of fertility according to the EFI. RESULTS: Of the 234 patients analyzed, 104 (44.4%) conceived postoperatively including 58 (55.8%) spontaneous pregnancies. An EFI of 0-4 for spontaneous pregnancies was associated with a lower cumulative pregnancy incidence compared to an EFI of 5-10 (52 versus 34 pregnancies respectively, Subdistribution Hazard Ratio (SHR) = 0.47; 95% CI [0.2; 1.1]; p = 0.08). An EFI of 0-4 was associated with a higher cumulative pregnancy rate for pregnancies obtained by artificial reproduction technology (ART), compared to an EFI of 5-10 (12 versus 6 pregnancies respectively, SHR = 1.9; CI95% [0.96; 3.8]; p = 0.06). Fecundability decreased from 12 months for EFI 0-4 and from 24 months for EFI 5-10. CONCLUSION: Our analysis suggests that patients with an unfavorable EFI (≤4) have more ART pregnancies than patients with a favorable EFI (≥5) and should be referred for ART shortly after surgery. Patients with a favorable EFI may attempt spontaneous pregnancy for 24 months before referral.

Management of uterine rupture during molar pregnancy.

Gestational trophoblastic disease (GTD) is rare and encompasses several clinicopathologic forms from pre-malignant to malignant disorders. Clinical presentation is most of the time dominated by vaginal bleeding. Only few cases of uterine rupture during GTD have been reported in literature. We present the case of a female patient admitted to the hospital for hemorrhagic shock secondary to a uterine rupture due to an undiagnosed GTD. After an emergency laparoscopy, the patient underwent total hysterectomy with bilateral salpingectomy and bilateral ovarian cystectomy. Pulmonary metastasis were discovered on imaging after stagnation of the beta-hCG level. The surgical treatment was completed by 6 cycles of Methotrexate followed by 7 cycles of Actinomycine D with a good response.

Do high-dose progestins impair sexual function in women treated for endometriosis? A prospective observational longitudinal study.

INTRODUCTION: High-dose progestins are used as an effective therapy for painful symptoms of endometriosis but their impact on sexual function has been poorly studied. The study aims to assess the impact of high-dose progestin on sexual function among women treated for endometriosis. MATERIAL AND METHODS: In this bicenter prospective observational study, women with endometriosis who received medical or surgical treatment for endometriosis and who were sexually active were included. They completed the Sexual Activity Questionnaire (SAQ, a validated tool) before (T0) and 12 months after (T1) endometriosis treatment. We classified patients into two groups according to whether they were using high-dose progestins at T1: a high-dose progestin group and a control group. The main outcome was sexual function measured by the SAQ score (from 0 to 30) at T1. The secondary outcomes were each individual SAQ item, the dyspareunia 100-mm visual analog scale (VAS) and the quality of life assessed with EuroQoL Group 5D Index (EQ-5D) at T1. We also assessed the change in dyspareunia VAS and quality of life between T0 and T1. The Ethics Committee of Ile-de-France (Act 2004-806, 9 August 2004) approved the study. RESULTS: Among 214 women included, 25 (12%) were exposed to high-dose progestins at T1. The SAQ score of women exposed to high-dose progestins was significantly lower compared with the control group, with or without adjustment for covariates (15.5 ± 6.3 vs 18.3 ± 6.2, P = .03, adjusted effect size -0.44 [95% CI -0.86 to -0.02], P = .04). High-dose progestin intake at T1 was associated with a lower subscore on two SAQ items: pleasure (1.8 ± 0.8 vs 2.2 ± 0.9, P = .02), and satisfaction with frequency of intercourse (1.2 ± 1.2 vs 1.8 ± 1.1, P = .02). In the overall population, dyspareunia VAS and quality of life assessed by EQ-5D improved between T0 and T1 (45 ± 29 at T0 vs 28 ± 29 at T1, P < .001; 0.78 ± 0.14 at T0 vs 0.86 ± 0.14 at T1, P < .001, respectively). At T1, the groups did not differ significantly for dyspareunia VAS (effect size 0.36 [95% CI -0.06 to 0.78], P = .10) and quality of life (EQ-5D, effect size 0.02 [95% CI -0.40 to 0.44], P = .91). CONCLUSION: In this observational study, high-dose progestins impair the sexual function of women treated for endometriosis even though they improved dyspareunia.

Resection of deep-infiltrating endometriosis could be a risk factor for uterine rupture: a case series with review of the literature.

OBJECTIVE: To highlight the possible correlation between deep-infiltrating endometriosis (DIE) resection and subsequent uterine rupture. DESIGN: Case series and review of the literature. SETTING: Endometriosis referral hospitals. PATIENTS: Seven young women who underwent laparoscopic resection of DIE, six of whom had uterine rupture before or during labor; the seventh patient had a posterior wall defect that placed her at increased risk of future uterine rupture. INTERVENTIONS: Diagnosis of uterine rupture before or during labor in patients with a history of prior resection of DIE, leading to delivery by emergency delivery section or emergency laparotomy for exploration and repair. MAIN OUTCOME MEASURES: Immediate neonate and maternal salvaging caesarean delivery or laparotomy followed by surgical correction of the rupture. RESULTS: As of 2019, no publications in the literature had considered uterine rupture among the obstetric complications of endometriosis. The reporting of such findings is crucial because of the increase in surgical management of endometriosis. We report seven cases of uterine rupture in pregnancy in women who had undergone resection of DIE. In six patients, surgeons found uterine rupture at the level of the previous resected endometriosis and diagnosed a posterior wall defect at the same level in one patient. CONCLUSIONS: Our case series sheds light on the potential increased risk of uterine rupture during pregnancy among women who have had a prior resection of DIE. In future, if these patients are considered high-risk pregnancy cases, their care should be managed by high-risk obstetric specialists.

Standardizing hysteroscopy teaching: development of a curriculum using the Delphi method.

BACKGROUND: Hysteroscopy is performed often and in many indications but is challenging to learn. Hands-on training in live patients faces ethical, legal, and economic obstacles. Virtual reality simulation may hold promise as a hysteroscopy training tool. No validated curriculum specific in hysteroscopy exists. The aim of this study was to develop a hysteroscopy curriculum, using the Delphi method to identify skill requirements. METHODS: Based on a literature review using the key words "curriculum," "simulation," and "hysteroscopy," we identified five technical and non-technical areas in which skills were required. Twenty hysteroscopy experts from different French hospital departments participated in Delphi rounds to select items in these five areas. The rounds were to be continued until 80-100% agreement was obtained for at least 60% of items. A curriculum was built based on the selected items and was evaluated in residents. RESULTS: From November 2014 to April 2015, 18 of 20 invited experts participated in three Delphi rounds. Of the 51 items selected during the first round, only 25 (49%) had 80-100% agreement during the second round, and a third round was therefore conducted. During this last round, 80-100% agreement was achieved for 31 (61%) items, which were used to create the curriculum. All 14 residents tested felt that a simulator training session was acceptable and helped them to improve their skills. CONCLUSIONS: We describe a simulation-based hysteroscopy curriculum focusing on skill requirements identified by a Delphi procedure. Its development allows standardization of training programs offered to residents.

Development of a French version of the Endometriosis Health Profile 5 (EHP-5): cross-cultural adaptation and psychometric evaluation.

PURPOSE: The Endometriosis Health Profile 5 (EHP-5) is a short version of an endometriosis-specific quality of life questionnaire. The objective of the study was to assess the psychometric validity of its French version. METHODS: A total of 125 patients with histologically proven endometriosis who underwent surgery for painful symptoms and 80 asymptomatic controls completed the EHP-5. Principal components analysis was performed to determine the dimensions of the instrument. Internal consistency was assessed using Cronbach's alpha. Construct validity was assessed by testing the relationship between the EHP-5 and the characteristics of endometriosis. RESULTS: For each item of EHP-5, endometriosis patients scored significantly higher than control women (p > 0.0001). Eleven items of the EHP-5 were unidimensional with excellent internal consistency (Cronbach's alpha = 0.92), and a summary aggregated index was then constructed. The EHP-5 index was sensitive to the presence of endometriosis, the type, location, severity of the disease, and pain or infertility as the main complaint with effect sizes ranging from 0.48 (95 % CI 0.11-0.85) for superficial endometriosis to 2.56 (95 % CI 2.18-2.93) for deeply infiltrating endometriosis. CONCLUSION: The French version of EHP-5 is valid and can be used for reporting patient-orientated outcome in future studies of French-speaking patients with endometriosis.

Optimal Combination of Non-Invasive Tools for the Early Detection of Potentially Life-Threatening Emergencies in Gynecology.

OBJECTIVES: Potentially life-threatening gynecological emergencies (G-PLEs) are acute pelvic conditions that may spontaneously evolve into a life-threatening situation, or those for which there is a risk of sequelae or death in the absence of prompt diagnosis and treatment. The objective of this study was to identify the best combination of non-invasive diagnostic tools to ensure an accurate diagnosis and timely response when faced with G-PLEs for patients arriving with acute pelvic pain at the Gynecological Emergency Department (ED). METHODS: The data on non-invasive diagnostic tools were sourced from the records of patients presenting at the ED of two hospitals in the Parisian suburbs (France) with acute pelvic pain between September 2006 and April 2008. The medical history of the patients was obtained through a standardized questionnaire completed for a prospective observational study, and missing information was completed with data sourced from the medical forms. Diagnostic tool categories were predefined as a collection of signs or symptoms. We analyzed the association of each sign/symptom with G-PLEs using Pearson's Chi-Square or Fischer's exact tests. Symptoms and signs associated with G-PLEs (p-value < 0.20) were subjected to logistic regression to evaluate the diagnostic value of each of the predefined diagnostic tools and in various combinations. RESULTS: The data of 365 patients with acute pelvic pain were analyzed, of whom 103 were confirmed to have a PLE. We analyzed five diagnostic tools by logistic regression: Triage Process, History-Taking, Physical Examination, Ultrasonography, and Biological Exams. The combination of History-Taking and Ultrasonography had a C-index of 0.83, the highest for a model combining two tools. CONCLUSIONS: The use of a standardized self-assessment questionnaire for history-taking and focal ultrasound examination were found to be the most successful tool combination for the diagnosis of gynecological emergencies in a Gynecological ED. Additional tools, such as physical examination, do not add substantial diagnostic value.

Bladder symptoms and urodynamic observations of patients with endometriosis confirmed by laparoscopy.

INTRODUCTION AND HYPOTHESIS: Patients with deep infiltrating pelvic endometriosis (DIE) often describe having lower urinary tract symptoms (LUTS). Bladder pain syndrome in women is also often associated with endometriosis. In this study, we aimed to describe the characteristics of LUTS and urodynamic observations in patients with posterior endometriosis versus those with posterior and anterior endometriosis. METHODS: This was a prospective observational study of 30 patients from two gynecologic surgical settings with experience in DIE surgery. All patients underwent preoperative standardized investigation including detailed evaluation of LUTS and urodynamic studies. During surgery, endometriosis locations were recorded and correlated to symptoms and urodynamic observations. RESULTS: Twenty-three patients (76.7 %) had one or more LUTS symptoms and 29 (96.7 %) had one or more abnormalities at urodynamic examination. At surgery, all patients had posterior endometriosis and ten of them also had anterior endometriosis. Patients with anterior endometriosis had increased bladder sensation (90.0 % versus 45.0 %, p = 0.024) and painful bladder filling (70.0 % versus 30.0, p = 0.04) compared with patients with posterior endometriosis only. Voiding symptoms (60.0 %), impairment of flowmetry (30.0 %), and increased maximum urethral closure pressure (90.0 %) were frequent and not correlated with any specific location. CONCLUSIONS: Endometriosis infiltrating the bladder wall is associated with painful bladder symptoms. Dysfunctional voiding suggests an impairment of the inferior hypogastric plexus by posterior DIE. Clinical preoperative evaluation of bladder function should be systematic; urodynamic tests could be of interest in selected patients with DIE. Endometriosis may be a major cause of bladder pain syndrome.

Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial.

BACKGROUND: Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion. METHODS: After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22 weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.

A self-assessed questionnaire can help in the diagnosis of pelvic inflammatory disease.

BACKGROUND: Pelvic inflammatory disease (PID) is often responsible for acute pelvic pain, yet its clinical diagnosis is difficult. The aim of this study was to develop and validate prediction rules for the diagnosis of PID in patients seen for acute pelvic pain, based solely on a self-assessed questionnaire. METHODS: From September 2006 to April 2008, 499 consecutive patients presenting at the gynecology emergency departments of 5 hospitals for acute pelvic pain completed a Self-Assessment Questionnaire for Gynecological Emergencies. Seventy-three were identified as having a PID. Two-thirds of the database was randomly selected for the derivation of the prediction rules, and the other third was used for internal validation. We developed 2 scores, one that rules out a diagnosis of PID and one that predicts PID, based on multiple logistic regression with jackknife estimates. These scores were then validated with the validation data set. RESULTS: Four variables were independently associated with PID: scattered pain radiation and/or diffuse pain, insidious pain, peritoneal irritation, and abnormal vaginal discharge. They were used to create a sensitive prediction model that rules out PID. Four other variables were used to build another model that predicted PID with high specificity: abnormal vaginal discharge, bilateral pelvic pain, constipation, and presence of an intrauterine device. The probability of PID for the patients in the low-risk group was 1.1% (95% confidence interval, 0.03-5.8), and the probability of PID in the high-risk group was 55% (95% confidence interval, 31.5-76.9). CONCLUSION: These 2 prediction rules that classify patients in low risk or high risk of PID, based on simple items collected by a self-assessed questionnaire that are composed only of case history and autodescription of the pain, may prove useful for diagnosing or ruling out PID in patients with acute pelvic pain.

Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™.

OBJECTIVE: The objective of this multicenter, randomized study was to investigate the efficacy of the hydrophilic resorbable film PREVADH™ in preventing postoperative adhesions following myomectomy. STUDY DESIGN: Women scheduled for laparotomic myomectomy with intramural and/or subserous myomas of >60mm in diameter, and who wished to preserve fertility, were eligible. Patients were randomized immediately prior to abdominal wall closure to receive either hydrophilic resorbable film applied directly to the incisions (P-Group, n=33) or 500mL Ringer's lactate solution instilled into the pelvic cavity (R-Group, n=28). Incidence, severity, and extent of postoperative adhesions to the uterine incisions and adnexal and abdominopelvic adhesions were assessed during second-look laparoscopy 10-20 weeks after the initial surgery. Unedited videotapes of this second-look procedure were reviewed by two blinded independent surgeons. RESULTS: Fifty-four patients (P-Group, n=28; R-Group, n=26) underwent second-look laparoscopy. Significantly fewer P-Group patients developed adhesions to uterine incisions than R-Group patients (43% vs. 92%, P=0.001). Adhesions, which were confirmed by independent reviewers, were found in significantly fewer P-Group sites than R-Group sites (29% vs. 76%, P=0.001). No serious adverse events related to the barriers used or adhesion-related complications were reported in either group. CONCLUSION: The hydrophilic resorbable anti-adhesion film PREVADH™ significantly reduced adhesion incidence and severity after laparotomic myomectomy. CLINICAL TRIAL REGISTRATION: NCT01388907 (www.clinicaltrials.gov).

Comparison of patient- and physician-based descriptions of symptoms of endometriosis: a qualitative study.

STUDY QUESTION: How do fully-comprehensive patient-centred descriptions of the symptoms of endometriosis compare with the physicians' description of the symptoms? SUMMARY ANSWER: The description of the painful symptoms due to endometriosis is based on numerous distinct parameters. The way these are used to describe symptoms and the way they are interpreted varies significantly between patients and clinicians. The descriptions of severe pelvic pain and dysmenorrhoea and dyspareunia by the clinicians were incomplete compared with those of the patients. WHAT IS KNOWN ALREADY: Painful symptoms due to endometriosis were found to be of little use to predict the location and severity of the disease. Currently there are few data on the patients' description of symptoms and no questionnaire is available to derive data from patients. STUDY DESIGN, SIZE, DURATION: Descriptions of painful symptoms by patients and by physicians were obtained by qualitative, interview-based study and analysed using Colaizzi's method. The patients planned to be operated on for painful endometriosis were volunteers for preoperative interview. They were recruited by purposeful sampling to represent different types of endometriosis [i.e. superficial endometriosis, ovarian endometriosis or deeply infiltrating endometriosis (DIE)], the women were selected so that at least five sites of endometriosis were included in the study. The clinicians were experts in endometriosis management. PARTICIPANTS/MATERIALS, SETTING, METHODS: Forty-one patients were recruited, in four reference centres. Among them, 33 had DIE in various locations, including intestinal endometriosis (n = 12) or bladder endometriosis (n = 5), 14 had ovarian endometriosis (including three without associated DIE) and 5 had only superficial endometriosis. The nine experts were French-speaking gynaecological surgeons practicing in university teaching hospitals (seven), a general hospital (one) or a private centre (one). MAIN RESULTS AND THE ROLE OF CHANCE: In total, 47 themes were identified of which 30 were perceived by both patients and clinicians, 12 by patients only and 5 by clinicians only. Themes fall into five general categories: (i) severe pelvic pain and dysmenorrhoea, (ii) dyspareunia, (iii) gastro-intestinal symptoms, (iv) bladder symptoms, (v) other symptoms. Patients' and clinicians' descriptions of symptoms were in agreement for general categories, but the clinicians' comprehensive description was incomplete, in particular concerning the severe pelvic pain and dysmenorrhoea's themes and the dyspareunia theme. Patients did not report any clear-cut distinction between pelvic pain and dysmenorrhoea and expressed a dimension of suffering and impaired quality of life inherent to painful symptoms. LIMITATIONS, REASONS FOR CAUTION: Most of the patients in the study had already had treatment for endometriosis, including ongoing hormonal treatment. Furthermore, all but a few patients had documented endometriotic lesions and no specific investigations to eliminate additional causes of functional pelvic pain were done. Finally due to the qualitative design of the study the result must be regarded as inferences. WIDER IMPLICATIONS OF THE FINDINGS: The present study provides a first person viewpoint of the painful experience of endometriosis by the patients in a subjective, phenomenological perspective, and points out the differences of perceptions between the physicians and the patients. The considerable variability in patients' descriptions suggests several distinct mechanisms are involved in explaining the pain related to endometriosis. The discordance between clinicians and patients might also reflect this kind of problem with the wording of the items. In future, if the goal is to properly understand the pain experienced by women with endometriosis, assessment tools using the words and phrases used in narratives of pain would potentially be very useful. STUDY FUNDING/COMPETING INTEREST(S): Funded by IPSEN, Boulogne-Billancourt, France. None of the authors has any conflict of interest to declare. TRIAL REGISTRATION NUMBER: Not applicable.

[Management of myoma: what is the place for hysterectomy and how to perform it?]. / Traitement des myomes : quelle est la place de l'hystérectomie et selon quelle technique ?

Hysterectomy is the most effective treatment for symptomatic myoma with no possible recurrence. Hysterectomy for myoma is associated with a high rate of patient satisfaction (95%). Quality of life is globally improved by hysterectomy, as is sexuality with less pelvic pain, asthenia, urinary symptoms and impaired mental health. Vaginal and laparoscopic routes should be preferred to diminish blood loss, hospital stay and postoperative pain. Patients with hysterectomy are at twice as much risk of requiring surgical treatment for incontinence later on. Stress urinary incontinence must be looked for during the preoperative history-taking.

Fertility after ectopic pregnancy: the DEMETER randomized trial.

STUDY QUESTION: Does treatment for the resolution of ectopic pregnancy (EP) affect subsequent spontaneous fertility [occurrence of an intrauterine pregnancy (IUP)]? SUMMARY ANSWER: There is no significant difference in 2 years subsequent fertility neither between methotrexate and conservative surgery for less active EP nor between conservative and radical surgery for the most active EP. WHAT IS KNOWN ALREADY: No randomized trial has compared radical and conservative surgery treatments. A recent review of the Cochrane database did not conclude about fertility due to insufficient data. Prospective studies from EP registries in two regions of France (Auvergne and Greater Lille) have suggested that fertility is similar after medical treatment and conservative surgery and lower after radical surgery. STUDY DESIGN, SIZE, DURATION: This randomized controlled trial included all women with an ultrasound-confirmed EP. Women were divided into two arms according to the activity of the EP (defined by Fernandez's score). In arm 1 (less active ectopic pregnancies, i.e. Fernandez's score <13 and no haemodynamic failure), medical treatment was considered practicable, and women were randomly allocated to conservative surgery with a systematic post-operative i.m. methotrexate injection within 24 h or to an i.m. methotrexate injection alone. In arm 2 (active ectopic pregnancies), medical treatment was considered impracticable, and, thus, all women had to undergo surgery; they were randomly allocated to either a radical or conservative procedure, the latter including a post-operative methotrexate injection. Sample sizes (n = 210 in arm 1 and n = 230 in arm 2) were computed to provide a statistical power of 80% to detect a 20% difference in subsequent cumulative fertility rates between treatments in each arm. The total duration of the trial was 5 years. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: The trial took place in 17 centres in France from 2005 to 2009. Two hundred and seven women were included in arm 1 and 199 in arm 2. Cumulative fertility curves were drawn with the Kaplan-Meier method and compared with the log-rank test. Hazard ratios (HRs) were computed with the Cox model. Analysis was performed according to the intention-to-treat principle. MAIN RESULTS: Arm 1: cumulative fertility curves were not significantly different between medical treatment and conservative surgery. HR was 0.85 (0.59-1.22) P = 0.37. The 2-year rates of IUP were 67% after medical treatment and 71% after conservative surgery. Arm 2: cumulative fertility curves were not significantly different between conservative and radical surgery. HR was 1.06 (0.69-1.63) P = 0.78. The 2-year rates of IUP were 70% after conservative surgery and 64% after radical surgery. LIMITATIONS, REASONS FOR CAUTION: Inclusion in this trial was more difficult than expected, especially in arm 2 in which women were reluctant to radical surgery. In consequence, the sample size was slightly lower than planned. However, due to a lower proportion of lost to follow-up than expected (10% instead of 15%), the statistical power remained very close to 80%. WIDER IMPLICATIONS OF THE FINDINGS: As it is a multicentre randomized trial, the results may be generalized with satisfactory confidence. The results of this trial invite gynaecologists to reconsider the management of EP and to modify balance between considerations of initial recovery and preservation of fertility. TRIAL REGISTRATION NUMBER: NCT00137982 on the WHO International Clinical Trials Registry Platform.

Therapeutic management of uterine fibroid tumors: updated French guidelines.

The medical management of symptomatic non-submucosal uterine fibroid tumors (leiomyomas or myomas) is based on the treatment of abnormal uterine bleeding by any of the following: progestogens, a levonorgestrel-releasing intrauterine device, tranexamic acid, nonsteroidal anti-inflammatory drugs, or GnRH analogs. Selective progesterone receptor modulators are currently being evaluated and have recently been approved for fibroid treatment. Neither combined estrogen-progestogen contraception nor hormone treatment of the menopause is contraindicated in women with fibroids. When pregnancy is desired, whether or not infertility is being treated by assisted reproductive technology, hysteroscopic resection in one or two separate procedures of submucosal fibroids less than 4 cm in length is recommended, regardless of whether they are symptomatic. Interstitial, also known as intramural, fibroids have a negative effect on fertility but treating them does not improve fertility. Myomectomy is therefore indicated only for symptomatic fibroids; depending on their size and number, and may be performed by laparoscopy or laparotomy. Physicians must explain to women the potential consequences of myomas and myomectomy on future pregnancy. For perimenopausal women who have been informed of the alternatives and the risks, hysterectomy is the most effective treatment for symptomatic fibroids and is associated with a high rate of patient satisfaction. When possible, the vaginal or laparoscopic routes should be preferred to laparotomy for hysterectomies for fibroids considered typical on imaging. Because uterine artery embolization is an effective treatment with low long-term morbidity, it is an option for symptomatic fibroids in women who do not want to become pregnant, and a validated alternative to myomectomy and hysterectomy that must be offered to patients. Myolysis is under assessment, and research on its use is recommended. Isolated laparoscopic ligation of the uterine arteries is a potential alternative to uterine artery embolization; it also complements myomectomy by reducing intraoperative bleeding. It is possible to use second-generation techniques of endometrial ablation to treat submucosal fibroids in women whose families are complete. Subtotal hysterectomy is a possible alternative to total hysterectomy for fibroid treatment, given that by laparotomy the former has a lower complication rate than the latter, while by laparoscopy, these rates are the same. In each case, the patient is informed about the benefit and risk associated with each therapeutic option.