Association between hospital procedure volume, socioeconomic status, comorbidities, and adverse events related to surgical abortion: A nationwide population-based cohort study.

BACKGROUND: Limited evidence exists on the influence of hospital procedure volume, socioeconomic status, and comorbidities on surgical abortion outcomes. OBJECTIVE: Our study aimed to assess the association between hospital procedure volume, individual and neighborhood deprivation, comorbidities, and abortion-related adverse events. STUDY DESIGN: A nationwide population-based cohort study of all women hospitalized for surgical abortion was conducted from January 1, 2018, to December 31, 2019 in France. Annual hospital procedure volume was categorized into four levels based on spline function visualization: very low (<80), low ([80-300[), high ([300-650[), and very high-volume (≥650) centers. The primary outcome was the occurrence of at least one surgical-related adverse event, including hemorrhage, retained products of conception, genital tract and pelvic infection, transfusion, fistulas and neighboring lesions, local hematoma, failure of abortion, admission to an intensive care unit or death. These events were monitored during the index stay and during a subsequent hospitalization up to 90 days. The secondary outcome encompassed general adverse events not directly linked to surgery. RESULTS: Of the 112,842 hospital stays, 4,951 (4.39%) had surgical-related adverse events and 256 (0.23%) had general adverse events. The multivariate analysis showed a volume-outcome relationship, with lower rates of surgical-related adverse events in very high-volume (2.25%, aOR=0.34, 95%CI [0.29-0.39], p<0.001), high-volume (4.24%, aOR=0.61, 95%CI [0.55-0.69], p<0.001), and low-volume (4.69%, aOR=0.81, 95%CI [0.75-0.88], p<0.001) when compared to very low-volume centers (6.65%). Individual socioeconomic status (aOR=1.69, 95%CI [1.47-1.94], p<0.001), neighborhood deprivation (aOR=1.31, 95% CI [1.22-1.39], p<0.001), and comorbidities (aOR=1.79, 95%CI [1.35-2.38], p<0.001) were associated with surgical-related adverse events. Conversely, the multivariate analysis of general adverse events did not reveal any volume-outcome relationship. CONCLUSION: The presence of a volume-outcome relationship underscores the need for enhanced safety standards in low-volume centers to ensure equity in women's safety during surgical abortions. However, our findings also highlight the complexity of this safety concern which involves multiple other factors including socioeconomic status and comorbidities that policymakers must consider.

The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial.

STUDY OBJECTIVE: To evaluate whether laparoendoscopic single-site surgery (LESS) offers advantages over conventional laparoscopy (CL) in benign adnexal surgery. DESIGN: Randomized controlled study. SETTING: Gynecology-Obstetrics Unit of the University Hospital of the Conception in Marseille, France. PATIENTS: Patients older than 18 years requiring ovarian cystectomy or salpingo-oophorectomy by laparoscopy for symptomatic ovarian cysts requiring benign or prophylactic surgery. INTERVENTIONS: In the case of ovarian cysts, premenopausal patients typically undergo a unilateral cystectomy, whereas postmenopausal patients undergo a unilateral or bilateral salpingo-oophorectomy upon a patient's request. In cases requiring prophylactic surgery, a bilateral salpingo-oophorectomy was performed. All participants were randomly assigned to either the LESS or the CL group. MEASUREMENTS AND MAIN RESULTS: Patients in both groups reported similar levels of pain at 24 hours: Simple Numerical Scale was 1.3 (standard deviation, 1.5) in the LESS group vs 1.7 (standard deviation, 1.5) in the CL group (p = .12), and there were no significant differences in postoperative pain at 2 hours, 4 hours, 6 hours, and 7 days. Furthermore, there was no difference in analgesic consumption. Regarding intraoperative criteria, the only difference was the longer operating time in the LESS group than the CL group. We also found that patients' satisfaction with their scar at 1 month may be higher with LESS than with CL. CONCLUSION: There was no significant difference between the 2 techniques in postoperative pain, although the LESS technique necessitated a longer operative time than the CL technique, while providing better aesthetic result patients.

Laparoscopic Multibipolar Radiofrequency Myolysis for Symptomatic Myomas in 10 Steps.

STUDY OBJECTIVE: To describe a minimal invasive 10-step technique of laparoscopic multibipolar radiofrequency myolysis for symptomatic myomas. DESIGN: A step-by-step video demonstration of the technique. SETTING: A woman with symptomatic FIGO 5 myoma of 60 mm of diameter, confirmed by magnetic resonance imaging. The patient included in this video gave consent for publication of the video and posting of the video online including social media, the journal website, scientific literature websites (such as PubMed, ScienceDirect, Scopus, etc.) and other applicable sites. INTERVENTIONS: Approximately 30% of women of child-bearing age with myomas will present with symptoms [1] that include chronic pelvic pain, abnormal uterine bleeding or infertility [2,3]. Data regarding fertility preservation and obstetric outcomes suggest that radiofrequency myoma ablation may offer an alternative to existing treatments for women who desire future fertility [4]. The local institutional review board stated that approval was not required because the video describes a technique and not a clinical case. In our center, all radiofrequency indications are discussed during a monthly multidisciplinary myomas meeting. This video presents the procedure divided into the following 10 steps: planning of the surgery; materials; installation; laparoscopic exploration; transvaginal ultrasound examination; visual and transvaginal ultrasound guided transparietal puncture of the myoma; control of the applicators' position; radiofrequency myolysis; end of myolysis, applicators removal; final check and additional procedures. CONCLUSION: Radiofrequency myolysis is a simple and reproductible procedure that can be offered as an alternative to myomectomy [5]. This video presents 10 steps to make the procedure easier to adopt and to reduce its learning curve.

Mild endometriosis of the uterosacral ligaments: a retrospective study of magnetic resonance imaging performance for diagnosis.

RESEARCH QUESTION: What are the diagnostic performances of magnetic resonance imaging (MRI) scans when used to identify mild endometriosis of the uterosacral ligaments (USL)? DESIGN: Monocentric retrospective study of patients who underwent a pelvic MRI followed by laparoscopy for determination of endometriosis between January 2016 and December 2020. Patients were included whether endometriosis of USL was suspected or not, but patients presenting large lesions that left no doubt as to their endometriotic nature on the MRI were excluded. Six criteria for the description of USL on MRI were studied to determine their diagnostic performances in predicting the presence of endometriosis on laparoscopy as follows: asymmetry, thickening, irregularity, straightness, the presence of a nodule or a hypersignal T1 spot. RESULTS: Seventy-seven patients were included. Among the criteria, 'asymmetry' and 'thickening' had the highest sensitivities (0.69 [95% confidence interval 0.54-0.80] and 0.51 [0.40-0.63], respectively) but moderate specificities (0.52 [0.31-0.73] and 0.62 [0.50-0.72]). Conversely, 'irregularity', 'nodule', 'straightness' and 'hypersignal T1 spot' were associated with high specificities (0.81 [0.70-0.89], 0.96 [0.89-0.99], 0.95 [0.87-0.99] and 0.99 [0.93-1.00], respectively) but poor sensitivities (0.22 [0.14-0.33], 0.12 [0.06-0.21], 0.08 [0.03-0.16] and 0.08 [0.03-0.16], respectively). The presence of at least one criterion for the description of the USL was associated with good sensitivity (0.80 [0.66-0.89]) but poor specificity (0.35 [0.16-0.57]). CONCLUSIONS: The results suggest that the identification of minimal changes in the normal appearance of USL should not automatically lead to a conclusion of mild endometriosis at this location.

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.

Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial.

STUDY OBJECTIVE: To compare the AirSeal insufflation system with the standard insufflation system for postoperative abdominal pain after laparoscopic hysterectomy for benign pathology. DESIGN: Randomized controlled trial. SETTING: Teaching Hospital La Conception, Marseille, France, February 2018 to July 2020. PATIENTS: A total of 80 patients scheduled for a laparoscopic hysterectomy for benign pathology (40 per group). INTERVENTION: Laparoscopic hysterectomy using the AirSeal insufflation system with a pneumoperitoneum between 8 and 10 mm Hg compared with the standard insufflation system with a pneumoperitoneum between 12 and 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: The primary end point was abdominal pain at 6 hours after the end of surgery, assessed by a Simple Numerical Scale from 0 to 10. The secondary end points were intraoperative (operating time and difficulty of the surgery felt by the operator), early postoperative (intensity of abdominal and scapular pain at H0 [end of surgery], H2 [two hours after the end of surgery, H12 [twelve hour after the end of surgery], H24 [twenty four hours after the end of surgery], H48 [fourty eight hours after the end of surgery]), and late postoperative (late postoperative complication, estimated time to return to normal life, and overall patient satisfaction assessed by the SF-12 general health survey). The median values for abdominal pain were not different between the 2 groups at 6 hours (AirSeal group median, 0; interquartile range, 2 vs standard laparoscopy group median, 1; interquartile range, 2; p = .41). The abdominal and scapular pain values were similar in both groups at all postoperative times. There were no differences between the groups regarding secondary end points. CONCLUSION: Use of the AirSeal insufflation system with low-pressure pneumoperitoneum in laparoscopic hysterectomy for a benign indication did not reduce postoperative abdominal and scapular pain.

Abortion: legislation and statistics in Europe.

Objective: The Parliamentary Assembly invited the member states of the Council of Europe to 'guarantee women's effective exercise of their right of access to a safe and legal abortion'. While abortion legislation and statistics give an impression of the legislative, cultural, and religious views of the societies and the socio-economic health of the female population, only one study conducted in 2011 looked into the current legislation and trends in terminations of pregnancy in the European Union.Materials and Methods: From January 2017 to December 2018, a group of experts, the authors of the present article, liaised with colleagues practising in 32 European countries to collect data on abortion legislation and statistics using three different questionnaires.Results: The article presents the results of this initiative and compares the status quo and recent trends in abortion legislation and statistics across Europe.Conclusions: The European legislations are still very heterogenous and abortion rates vary widely between countries, confirming that laws do not correlate with abortion rates. This compilation of data, also available on a website (www.abort-report.eu), may help to change laws to better meet the needs of women who decided to have an abortion as a solution to the underlying problem of an unwanted pregnancy.

Progression of adenomyosis magnetic resonance imaging features under ulipristal acetate for symptomatic fibroids.

RESEARCH QUESTION: What is the evolution of adenomyosis on magnetic resonance imaging (MRI) after a 3-month treatment course of daily 5 mg doses of ulipristal acetate (UPA) for symptomatic fibroids? DESIGN: A monocentric prospective pilot study on patients who underwent a 3-month treatment course of UPA for symptomatic fibroids between January 2014 and December 2017. Patients underwent pelvic MRI shortly before (pre-MRI) and after treatment (post-MRI). The diagnosis of adenomyosis on MRI was defined by the observation of intramyometrial cysts and/or haemorrhagic foci within these cystic cavities and/or a thickening of the junctional zone >12 mm. The progression of adenomyosis was defined by the presence of at least one of the aforementioned criteria of adenomyosis on the pre-MRI and by at least one of the following on the post-MRI: (i) increased thickness of the junctional zone ≥20% and/or (ii) increased number of intramyometrial cysts. The appearance of adenomyosis was defined by the absence of the aforementioned criteria of adenomyosis on the pre-MRI and the presence of at least one of these criteria on the post-MRI. RESULTS: Seventy-two patients were included. The MRI features of adenomyosis progressed for 12 of 15 patients (80.0%) for whom adenomyosis was identified on the pre-MRI. An appearance of adenomyosis was identified after treatment for 15 of 57 patients (26.3%) for whom adenomyosis was not identified on the pre-MRI. CONCLUSIONS: A 3-month treatment course of daily 5 mg doses of UPA could provoke a short-term progression or an emergence of typical adenomyosis intramyometrial cysts on MRI examinations.

Video-based self-assessment enhances laparoscopic skills on a virtual reality simulator: a randomized controlled trial.

BACKGROUND: Hysterectomy rates are decreasing in many countries, and virtual reality (VR) simulators bring new training opportunities for residents. As coaching interventions while training on a simulated complex procedure represents a resource challenge, alternative strategies to improve surgical skills must be investigated. We sought to determine whether self-guided learning using a video-based self-assessment (SA) leads to improved surgical skills in laparoscopic hysterectomy (LH) on a VR simulator. METHODS: Twenty-four gynecology residents from two university hospitals were randomized into an SA group (n = 12) and a Control group (n = 12). Each participant's baseline performance on a validated VR basic task was assessed. Both groups then performed three virtually simulated LHs during which the participants received no guidance nor feedback. Following each LH, the SA group participants rated the video of their own performance using a generic and a procedure-specific rating scale, while the Control group participants watched an LH video demonstration. The LH videos of both groups' participants were blindly reviewed and rated by expert surgeons, using modified Objective Structured Assessment of Technical Skills scores (OSATS). Objective metrics recorded by the VR simulator were also compared. RESULTS: There was no difference between the groups' baseline performances on the VR basic task. For the first LH, the OSATS-derived scores did not differ between SA and Control groups (9 [7-13] versus 9 [8-14]; p = 0.728). For the third LH, the OSATS-derived scores were higher for the SA group than for the Control group (17 [15-21] versus 15 [11-17], p = 0.039). Between the two groups, the objective metrics did not differ from the first to the third LH. CONCLUSIONS: The use of a structured video-based SA leads to improved procedural skills in LH on a VR simulator compared to watching benchmark expert performance, in a population of residents with moderate experience in the operating room.

Performance Assessment for Total Laparoscopic Hysterectomy in the Operating Room: Validity Evidence of a Procedure-specific Rating Scale.

STUDY OBJECTIVE: The technical conduct of total laparoscopic hysterectomy (LH) is critical to surgical outcomes. This study explored the validity evidence of an objective scale specific to the assessment of technical skills (H-OSATS) for 7 tasks of an LH with salpingo-oophorectomy procedure performed in the operating room. DESIGN: Observational cohort study. SETTING: Two academic hospitals in Marseille and Montpellier, France. PATIENTS: Three groups of operators (novice, intermediate, and experienced surgeons) were video recorded during their live performances of LH on a simple case. For each group, a dozen unedited videos were obtained for the following tasks: division of the round ligament, division of the infundibulopelvic ligament, creation of the bladder flap, opening of the posterior peritoneum, division of the uterine vessels, colpotomy, and closure of the vault. INTERVENTIONS: Two qualified raters blindly assessed each video using the H-OSATS rating scale. Inter-rater reliability and test-retest reliability were calculated as measures of internal structure. In a separate round of evaluations, the raters provided a global competent/noncompetent decision for each performance. As a measure of consequential validity, a pass/fail score was set for each task using the contrasting group method. MEASUREMENTS AND MAIN RESULTS: Three tasks (creation of the bladder flap, colpotomy, and closure of the vault) displayed sound validity evidence: a meaningful total score difference among the 3 groups of experience as well as between the intermediate and experienced surgeons, reliability outcomes of >0.7, and a pass/fail score with a theoretical false-positive rate of <10%. CONCLUSION: The validity evidence of the H-OSATS rating scale differed for separate evaluations of the 7 tasks. Three tasks (i.e., creation of the bladder flap, colpotomy, and closure of the vault) revealed sound validity evidence, including at the level of the attending surgeon, whereas other tasks were more consistent with low-stakes formative evaluation standards.

Surgical Management of Urinary Tract Endometriosis: A 1-year Longitudinal Multicenter Pilot Study at 31 French Hospitals (by the FRIENDS Group).

STUDY OBJECTIVE: To describe the surgical management and risks of postoperative complications of patients with urinary tract endometriosis in France in 2017. DESIGN: Multicenter retrospective cohort pilot study. SETTING: Departments of gynecology at 31 expert endometriosis centers. PATIENTS: All women managed surgically for urinary tract endometriosis from January 1, 2017, to December 31, 2017. We distinguished patients with isolated bladder endometriosis or isolated ureteral endometriosis (IUE) from those with endometriosis in both locations (mixed locations [ML]). INTERVENTIONS: Surgeons belonging to the French Colorectal Infiltrating Endometriosis Study (FRIENDS) group enrolled patients who filled a 24-item questionnaire on the day of the inclusion and 3 months later. Data were collected on operative routes, surgical management, and postoperative complications according to the Clavien-Dindo classification in a single anonymized database. MEASUREMENTS AND MAIN RESULTS: A total of 232 patients from 31 centers were included. Isolated bladder endometriosis was found in 82 patients (35.3%), IUE in 126 patients (54.4%), and ML in 24 patients (10.3%). Surgery was performed by laparoscopy, laparotomy, or robot-assisted laparoscopy in 74.1%, 11.2%, and 14.7% of the cases, respectively. Among the 150 ureteral lesions (IUE and ML), 114 were managed with ureterolysis (76%), 28 with ureteral resection (18.7%), 4 with nephrectomy (2.7%), and 23 with cystectomy (15.3%). Concerning bladder endometriosis, a partial cystectomy was performed in 94.3% of the cases. We reported 61 postoperative complications (26.3%): 44 low-grade complications according to the Clavien-Dindo classification (18%), 16 grade III complications (7%), and 1 grade IV complication (peritonitis). CONCLUSION: The surgical management of ureteral and bladder endometriosis is usually feasible and safe through laparoscopic surgery. Ureteral resection, when necessary, is more strongly associated with laparotomy and with more complications than other procedures. Prospective controlled studies are still mandatory to assess the best surgical management for patients.

Learning Intracorporeal Suture on Pelvitrainer Using a Robotized Versus Conventional Needle Holder.

BACKGROUND: Laparoscopy is the gold standard approach in numerous surgical procedures. A new generation of robotized instruments has been developed to compensate for the ergonomic constraints of conventional instruments. The main objective was to compare the learning curves of novices for intracorporeal suturing on a laparoscopy pelvitrainer, using either a robotized needle holder or conventional needle holders. The post-training performances under ergonomically difficult conditions were also analyzed. MATERIALS AND METHODS: Fifth-year medical students were randomized in group A using a robotized needle holder (JAIMY; Endocontrol, Grenoble, France) and group B using straight conventional needle holders. They undertook four training sessions (intracorporeal knot-tying task) followed by an evaluation session (intracorporeal knots-tying task, frontal suture, and hexagonal suture). RESULTS: Twenty participants were included. The performances of the two groups (n = 10) were not significantly different at baseline. During the training sessions, there was a learning curve with a plateau at the third session for both the groups. At the final evaluation session, there was no significant difference between group A and group B for the intracorporeal knot-tying task (median fundamentals of laparoscopic surgery score: 468 versus 474.5 respectively; P = 0.762). There was a significant difference between group A and group B for the frontal suture (median global score: 15.75 versus 3.75 respectively; P = 0.005) but not for the hexagonal suture (median global score: 18 versus 15 respectively; P = 0.284). CONCLUSIONS: Learning curves were equally fast using the robotized needle holder versus conventional instruments and led to equivalent performances. Under ergonomically difficult conditions, the robotized needle holder provided an advantage relative to conventional instruments.

Laparoscopic Essure® Device Removal by En Bloc Salpingectomy-Cornuectomy with Intraoperative X-Ray Checking: A Retrospective Cohort Study.

STUDY OBJECTIVE: To evaluate the feasibility, efficacy, and morbidity of Essure® device removal via laparoscopic en bloc salpingectomy-cornuectomy resection (LSC) and the utility of confirmation of complete removal with an intraoperative X-ray of the removed specimen (IX-S). DESIGN: Retrospective observational cohort study. SETTING: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. PATIENTS: Women who were not seeking future fertility seeking Essure® device removal by salpingectomy, between February 2017 and August 2018. INTERVENTIONS: All women underwent LSC. An IX-S was performed to confirm complete Essure® device removal. In the case of an unsatisfactory IX-S, an intraoperative pelvic X-ray control of the patient (IX-P) was performed. If IX-P diagnosed residual Essure® fragments, an additional resection was performed, and the removed tissue was checked by IX-S. MEASUREMENTS AND MAIN RESULTS: We included 72 women, and a total of 140 Essure® devices were removed. The IX-S confirmed complete Essure® device removal in 131 of 140 cases (93.6%) in 63 of 72 women (87.5%). Out of the 9 women with unsatisfactory IX-S, 6 had no residual Essure® fragments at IX-P, and Essure® device removal was considered complete. Three women had a persistent Essure® fragment at IX-P: an additional resection allowed complete removal in 2 cases and resulted in failure in 1 of 140 case (0.7%). There were 2 of 72 women (2.8%) intraoperative complications and 4 of 72 women (5.6%) postoperative grade 1 complications according to the Clavien-Dindo classification. CONCLUSION: Essure® device removal by LSC appears to be an effective and safe procedure. IX-S is a useful method to evaluate whether the removal of Essure® device is complete during an LSC procedure.

Isolated ipsilateral local recurrence of breast cancer: predictive factors and prognostic impact.

BACKGROUND: Tumour features associated with isolated invasive breast cancer (BC) ipsilateral local recurrence (ILR) after breast conservative treatment (BCT) and consequences on overall survival (OS) are still debated. Our objective was to investigate these points. METHODS: Patients were retrospectively identified from a cohort of patients who underwent BCT for invasive BC in 16 cancer centres. End-points were ILR rate and OS. The impact of ILR on OS was assessed by multivariate analysis (MVA) for all patients and according to endocrine receptors (ERs) and grade or tumour subtypes. RESULTS: Of 15,570 patients, ILR rate was 3.1%. Cumulative ILR rates differed according to ERs/grade (ERs+/Grade2: HR 1.42, p = 0.010; ERs+/Grade3: HR 1.41, p = 0.067; ERs-: HR 2.14, p < 0.0001), endocrine therapy (HR 2.05, p < 0.0001) and age < 40-years old (HR 2.28, p = 0.005) in MVA. When MVA was adjusted on tumour subtype, the latter was the only independent factor. OS-after-ILR was significantly different according to ILR-free intervals (HR 4.96 for ILR-free interval between 2 and 5-years and HR 9.00 when < 2-years, in comparison with ≥ 5-years). CONCLUSION: ERs/Grade status, lack of endocrine therapy and tumour subtypes predict isolated ILR risk in patients treated with BCT. Short ILR-free-intervals represent a strong pejorative factor for OS. These results may help selecting initial treatment as well as tailoring ILR systemic chemotherapy.

Progression of deep infiltrating rectosigmoid endometriotic nodules.

STUDY QUESTION: What is the risk of progression of deep endometriotic nodules infiltrating the rectosigmoid? SUMMARY ANSWER: There is a risk of progression of deep endometriotic nodules infiltrating the rectosigmoid, particularly in menstruating women. WHAT IS KNOWN ALREADY: Currently, there is a lack of acceptance in the literature on the probability that deeply infiltrating rectosigmoid endometriotic nodules progress in size. STUDY DESIGN, SIZE, DURATION: We conducted a monocentric case-control study between September 2016 and March 2018 at Rouen University Hospital. We enrolled 43 patients who were referred to our tertiary referral centre with deep endometriosis infiltrating the rectosigmoid, who had undergone two MRI examinations at least 12 months apart and had not undergone surgical treatment of rectosigmoid endometriosis during this interval. PARTICIPANTS/MATERIALS, SETTING, METHODS: MRI images were reinterpreted by a senior radiologist with experience and expertise in endometriosis, who measured the length and thickness of deep infiltrating colorectal lesions. Intra- and inter-observer reliability were tested on 30 randomly selected cases. We defined 'progression' of a nodule as an increase of ≥20% in length or in thickness and 'regression' of a lesion as a decrease of ≥20% in length or in thickness between two MRIs. Any nodule for which the variation in length and thickness was <20% was considered as 'stable'. Patients were divided into three groups based on evidence of progression, regression or stability of deep endometriotic nodules between their two MRI examinations. The total length of any period of amenorrhoea between the two MRI examinations, due to pregnancy, breastfeeding or hormonal treatment, was recorded. The total proportion of the time between MRIs where amenorrhoea occurred was compared between groups. MAIN RESULTS AND THE ROLE OF CHANCE: Eighty-six patients underwent at least two MRIs for deep endometriosis infiltrating the sigmoid or rectum between September 2016 and March 2018. Of these, we excluded 10 patients with an interval of <12 months between MRIs, 10 patients who underwent surgery between MRIs, 17 patients for whom at least 1 MRI was considered to be of poor quality and 6 patients for whom no deep colorectal lesion was found on repeat review of either MRI. This resulted in a total of 43 patients eligible for enrolment in the final analysis. Mean time (SD) between MRIs was 38.3 (22.1) months. About 60.5% of patients demonstrated stability of their colorectal lesions between the two MRIs, 27.9% of patients met the criteria for 'progression' of lesions and 11.6% met the criteria for 'regression' of lesions. There was no significant difference in time interval between MRIs for the three groups (P = 0.76). Median duration of amenorrhoea was significantly lower in women with progression of lesions (7.5 months) when compared to those with stability of lesions (8.5 months) or regression of lesions (21 months) (P < 0.001). Median duration of amenorrhoea (expressed as percentage of total time between two MRIs) was also found to be significantly lower in the group demonstrating progression (15.1%) when compared to the group demonstrating stability (19.2%) and the group demonstrating regression (94.1%; P = 0.006). Progression of rectosigmoid nodules was observed in 34% of patients without continuous amenorrhoea, in 39% who had never had amenorrhoea and in no patients with continuous amenorrhoea. LIMITATIONS, REASONS FOR CAUTION: Due to a lack of universally accepted criteria for defining the progression or regression of deep endometriotic nodules on MRI, the values used in our study may be disputed. Due to the retrospective design of the study, there may be heterogeneity of interval between MRIs, MRI techniques used, reason for amenorrhoea and duration of amenorrhoea. The mean inter-MRI interval was of short duration and varied between patients. Our findings are reported for only deep endometriosis infiltrating the rectosigmoid and cannot be extrapolated, without caution, to nodules of other locations. WIDER IMPLICATIONS OF THE FINDINGS: Patients with deeply infiltrating rectosigmoid endometriotic nodules, for which surgical management has not been performed, should undergo surveillance to allow detection of growth of nodules, particularly when continuous amenorrhoea has not been achieved. This recommendation is of importance to young patients with rectosigmoid nodules who wish to conceive, in whom first line ART is planned. There is a very low risk of progression of deep endometriotic nodules infiltrating the rectosigmoid in women with amenorrhoea induced by medical therapy, lactation or pregnancy. STUDY FUNDING/COMPETING INTEREST(S): No funding was received for this study. The authors declare no competing interests related to this study.

Predictors of uterine fibroid volume reduction under ulipristal acetate: a prospective MRI study.

RESEARCH QUESTION: Can patient and/or uterine fibroid characteristics predict the volume reduction of fibroids under ulipristal acetate (UPA) treatment? DESIGN: This was a monocentric observational prospective cohort study of women with symptomatic fibroids who were willing to undergo surgery after a 3-month treatment of daily 5 mg doses of UPA. Patients underwent magnetic resonance imaging before and after treatment, and the volumes of the three largest fibroids were assessed. The reduction in volume was assessed qualitatively: fibroids decreasing in volume were considered to be 'responsive' to treatment, and fibroids that were stable or increased in volume were considered to be 'non-responsive'. Comparisons were made of patient (age and body mass index) and fibroid (initial volume, number and location) characteristics between fibroids that were responsive and non-responsive to UPA treatment. RESULTS: Fifty-three women were included in the final analysis and 116 fibroids were measured. The initial number and initial volume of the fibroids were statistically associated with the response to UPA treatment (adjusted odds ratio [OR] 0.645, 95% confidence interval [CI] 0.461-0.903, P = 0.0115 for number of fibroids, and adjusted OR 1.447, 95% CI 1.063-1.970, P = 0.0195 for initial volume, with a log-linear relationship). Submucosal fibroids had a higher response rate to treatment (i.e. a decrease in volume) than intramural fibroids (21/25 [84.0%] versus 15/28 [53.6%]; P = 0.0490; adjusted OR 4.478, 95% CI 1.007-19.918). CONCLUSIONS: The location, initial volume and number of fibroids may allow prediction of the outcome of a single 3-month treatment course of daily 5 mg doses of UPA in terms of reduction in volume before surgery.

Vaginal Hysterectomy with Salpingectomy for Essure Insert Removal.

STUDY OBJECTIVE: To evaluate the feasibility of an en-bloc salpingectomy at the time of vaginal hysterectomy for removal of Essure inserts. DESIGN: Prospective observational study (Canadian Task Force classification II-1). SETTING: Monocenter study at the Conception University Hospital Center, Marseille, France. PATIENTS: Women seeking removal of the Essure device and candidate for vaginal hysterectomy from January 1, 2017 to January 31, 2018. INTERVENTIONS: Patient underwent a total hysterectomy and bilateral salpingectomy by the vaginal route (VH-S) with en-bloc removal of each hemiuterus with the ipsilateral fallopian tube, thereby allowing for removal of the Essure inserts without fragmentation. MEASUREMENTS AND MAIN RESULTS: Twenty-six VH-S were performed. There was no converted case to laparoscopy or laparotomy because of issues regarding feasibility or complications. Removal of each hemiuterus with the ipsilateral tube as a single unit was feasible in all cases. There was 1 Clavien-Dindo grade 1 perioperative complication: a bladder injury that required 10days of urinary catheterization. There were 2 grade 2 postoperative complications: 1 case of metrorrhagia of a granuloma on the vaginal fundus that was treated with silver nitrate and 1 case of acute urinary retention that required urinary catheterization for 24hours. CONCLUSION: Performing a VH-S with en-bloc removal of the hemiuterus with the ipsilateral tube without fragmentation orsectioning of the Essure inserts appears to be feasible. The vaginal route can hence be an approach for women who undergo hysterectomy during Essure insert surgery removal.

Risk Factors of Post-Large Loop Excision of the Transformation Zone Recurrent High-Grade Cervical Intraepithelial Lesion: A Prospective Cohort Study.

OBJECTIVE: The aim of the study was to identify the risk factors of post-large loop excision of the transformation zone (LLETZ) recurrent disease and the impact of colposcopic guidance at the time of LLETZ on that risk. MATERIALS AND METHODS: From December 2013 to July 2014, 204 patients who had undergone LLETZ for the treatment of high-grade intraepithelial lesion with fully visible cervical squamocolumnar junction were included. The use of colposcopy during each procedure was systematically documented. The dimensions and volume of LLETZ specimens were measured at the time of the procedure before formaldehyde fixation. All participants were invited for a follow-up. The primary endpoint was the diagnosis of post-LLETZ recurrent disease defined as the histologic diagnosis of a high-grade cervical intraepithelial lesion. RESULTS: The median duration of post-LLETZ follow-up was 25.8 months. Recurrent disease was diagnosed in 8 (3.6%) patients. Older than 38 years (adjusted hazard ratio [aHR] = 11.9, 95% CI = 1.6-86.0), history of excisional therapy (aHR = 21.6, 95% CI = 3.5-135.3), and the absence of colposcopy for the guidance of LLETZ (aHR = 6.4, 95% CI = 1.1-37.7) were found to significantly increase the risk of post-LLETZ recurrent disease. The dimensions and volume of the specimen were not found to have any impact. Only positive endocervical margins were identified to significantly increase the risk of post-LLETZ recurrent disease (aHR = 14.4, 95% CI = 2.0-101.1). CONCLUSIONS: Risk factors of post-LLETZ recurrent disease are older than 38 years, history of excisional therapy, positive endocervical margins, and lack of colposcopic guidance at the time of LLETZ.

Risk Factors of Inadequate Colposcopy After Large Loop Excision of the Transformation Zone: A Prospective Cohort Study.

OBJECTIVE: The aim of the study was to identify the risk factors of post-large loop excision of the transformation zone (LLETZ) inadequate colposcopy. MATERIALS AND METHODS: From December 2013 to July 2014, a total of 157 patients who had a LLETZ performed for the treatment of high-grade intraepithelial lesion with fully visible cervical squamocolumnar junction were included. All procedures were performed using semicircular loops. The use of colposcopy made during each procedure was systematically documented. Dimensions and volume of LLETZ specimens were measured at the time of procedure, before formaldehyde fixation. All participants were invited for a follow-up colposcopy 3 to 6 months after LLETZ. Primary end point was the diagnosis of post-LLETZ inadequate colposcopy, defined by a not fully visible cervical squamocolumnar junction and/or cervical stenosis. RESULTS: Colposcopies were performed in a mean (SD) delay of 136 (88) days and were inadequate in 22 (14%) cases. Factors found to significantly increase the probability of post-LLETZ inadequate colposcopy were a history of previous excisional cervical therapy [adjusted odds ratio (aOR) = 4.29, 95% CI = 1.12-16.37, p = .033] and the thickness of the specimen (aOR = 3.12, 95% CI = 1.02-9.60, p = .047). The use of colposcopy for the guidance of LLETZ was statistically associated with a decrease in the risk of post-LLETZ inadequate colposcopy (aOR = 0.19, 95% CI = 0.04-0.80, p = .024) as the achievement of negative endocervical margins (aOR = 0.26, 95% CI = 0.08-0.86, p = .027). CONCLUSIONS: Although the risk of post-LLETZ inadequate colposcopy is increased in patients with history of excisional therapy and with the thickness of the excised specimen, it could be reduced with the use of colposcopic guidance and the achievement of negative endocervical margins.