Understanding Minimally Invasive Gynaecologic Surgery Fellowship Training in Canada: A National Survey of Recent Graduates.

OBJECTIVE: To characterize fellowship training experiences in the 11 Canadian minimally invasive gynaecologic surgery (MIGS) programs and compare the surgical exposure of fellows in these programs to that of the American Association of Gynecologic Laparoscopists (AAGL) accredited fellowship in MIGS (FMIGS). METHODS: In this cross-sectional study, 2017 and 2018 MIGS fellowship graduates across Canada were given a web-based survey via SurveyMonkey software to evaluate 5 key components of postgraduate fellowship curricula: 1) surgical exposure; 2) teaching and evaluation methods; 3) research experience; 4) clinical responsibilities; and 5) pursuit of other academic endeavours. Interest in creating a national standardized curriculum and seeking accreditation for MIGS fellowships were also examined. RESULTS: The survey attained a 91% (20/22) response rate of the target population. All Canadian MIGS programs met the minimum standards for at least 62% (8/13) of the surgical competencies listed by the AAGL, with office hysteroscopy being the procedure with the largest discordance. Half of respondents (10/20) attended a program with an established curriculum, and 75% (15/20) believed there would be a benefit to standardizing training nationwide. Seventy percent (14/20) had published at least one manuscript during their fellowship and 60% (12/20) pursued postgraduate degrees. The majority (55%; 11/20) felt certain that MIGS should become a credentialed fellowship in Canada. CONCLUSION: Canada has made meaningful progress in MIGS training over the past decade with 11 well-established fellowship programs. Although this survey identifies a general interest in standardized training and accreditation for Canadian MIGS programs, more research is needed on how best to accomplish this.

Technicity in Canada: A Nationwide Whole-Population Analysis of Temporal Trends and Variation in Minimally Invasive Hysterectomies.

STUDY OBJECTIVE: The objective of our study was to provide a contemporary description of hysterectomy practice and temporal trends in Canada. DESIGN: A national whole-population retrospective analysis of data from the Canadian Institute for Health Information. SETTING: Canada. PATIENTS: All women who underwent hysterectomy for benign indication from April 1, 2007, to March 31, 2017, in Canada. INTERVENTIONS: Hysterectomy. MEASUREMENTS AND MAIN RESULTS: A total of 369 520 hysterectomies were performed in Canada during the 10-year period, during which the hysterectomy rate decreased from 313 to 243 per 100 000 women. The proportion of abdominal hysterectomies decreased (59.5% to 36.9%), laparoscopic hysterectomies increased (10.8% to 38.6%), and vaginal hysterectomies decreased (29.7% to 24.5%), whereas the national technicity index increased from 40.5% to 63.1% (p <.001, all trends). The median length of stay decreased from 3 (interquartile range 2-4) days to 2 (interquartile range 1-3), and the proportion of patients discharged within 24 hours increased from 2.1% to 7.2%. In year 2016-17, women aged 40 to 49 years had significantly increased risk of abdominal hysterectomy compared with women undergoing hysterectomy in other age categories (p <.001). Comparing women with menstrual bleeding disorders, women undergoing hysterectomy for endometriosis (adjusted relative risk [aRR] 1.36; 95% confidence interval [CI], 1.28-1.44) and myomas (aRR 2.01; 95% CI, 1.94-2.08) were at increased risk of abdominal hysterectomy, whereas women undergoing hysterectomy for pelvic organ prolapse and pelvic pain (aRR 1.47; 95% CI, 1.41-1.53) were at decreased risk. Using Ontario as the comparator, Nova Scotia (aRR 1.35; 95% CI, 1.27-1.43), New Brunswick (aRR 1.25; 95% CI, 1.18-1.32]), Manitoba (aRR 1.35; 95% CI, 1.28-1.43), and Newfoundland and Labrador (aRR 1.18; 95% CI, 1.10-1.27) had significantly higher risks of abdominal hysterectomy. In contrast, Saskatchewan (aRR 0.75; 95% CI, 0.74-0.77) and British Columbia (aRR 0.86; 95% CI, 0.85-0.88) had significantly lower risks, whereas Prince Edward Island, Quebec, and Alberta were not significantly different. CONCLUSION: The proportion of minimally invasive hysterectomies for benign indication has increased significantly in Canada. The declining use of vaginal approaches and the variation among provinces are of concern and necessitate further study.

Treatment Choices in a National Cohort of Canadian Women With Symptomatic Uterine Fibroids.

OBJECTIVES: To describe treatment choices made at the time of enrollment in CAPTURE, a Canadian patient registry for women with symptomatic uterine fibroids (UFs), and to define demographic and clinical characteristics that independently predict these choices. METHODS: Women arranging appointments for UF care were eligible to enrol. At the time of the enrollment visit, women's self-reported treatment histories were noted, along with their clinical characteristics. Tretment options were discussed and chosen during that visit. Patients could choose medical and/or surgical treatment, or they could opt for no active treatment (i.e., "watchful waiting"); treatment decisions were not binding. RESULTS: The most common medication proposed and chosen was ulipristal acetate (UPA), and the most common procedure was myomectomy. These treatments were also the most commonly identified in patients' histories. Medication alone and medication in combination with surgery were the most common treatment approaches chosen (46% and 26%, respectively). Surgery alone and watchful waiting were chosen by 14% and 13% of patients, respectively. Significant predictors of active treatment included patient pregnancy plans, overall symptom severity, and prior treatment history (medical and surgical). Other parameters, including patient age and history of specific UF symptoms, appear to influence the choice of medical therapies (UPA, gonadotropin-releasing hormone agonists, or other options) and procedures (myomectomy or hysterectomy). CONCLUSIONS: This real-world study documents the patient factors associated with the treatment decisions of women seeking care for symptomatic UFs in contemporary Canadian gynaecology practice. Subsequent analyses will follow the outcomes of these treatments over two years in this population.

Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial.

BACKGROUND: Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown. METHODS: Smart Step is a pilot randomized trial of smartphone-enabled HBET vs walking advice in patients with symptomatic PAD in an inner-city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone-based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6-minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year. RESULTS: A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants. CONCLUSIONS: The potential significance of this trial will be to provide preliminary evidence of a home-based, "mobile-first" approach for delivering a structured exercise rehabilitation program. Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.

Case Series of Reproductive Outcomes after Laparoscopic Radiofrequency Ablation of Symptomatic Myomas.

STUDY OBJECTIVE: To analyze pregnancy delivery and safety outcomes after patient receipt of percutaneous, laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation (Lap-RFA) for symptomatic uterine myomas. DESIGN: Case series (2010-2017); evidence was obtained from 2 randomized, controlled trials (level I), 6 cohort studies (level II-2), and in commercial settings (level II-3). SETTING: Multiple sites in the United States, Canada, Europe, and Latin America (university hospitals, community hospitals, and stand-alone surgery centers). Commercial cases were United States based and followed US Food and Drug Administration clearance of Lap-RFA. PATIENTS: Premenopausal adult women with symptomatic uterine myoma types 1 through 6. INTERVENTIONS: The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance. MEASUREMENTS AND MAIN RESULTS: Safety unknowns included the safety of a full-term pregnancy for mother and baby, rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and vaginal versus cesarean delivery. A total of 28 women (mean age = 35.0 ± 3.4 years) conceived a total of 30 times after Lap-RFA, either as part of a clinical study or in commercial settings. The number of myomas treated per patient ranged from 1 to 7. The diameter of treated myomas ranged from 0.9 to 11.0 cm. Most patients had 1 or 2 myomas, and most myomas were ≤5.5 cm in maximal diameter. The 30 pregnancies resulted in 26 full-term live births (86.7%), all healthy infants, with an equal distribution of vaginal and cesarean deliveries. Four (13.3%) spontaneous abortions occurred. No cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction were reported. One event each of placenta previa and postpartum hemorrhage were reported. CONCLUSION: Conception and safe, full-term pregnancy are achievable after Lap-RFA of symptomatic myomas. Additional large, rigorous, multivariate prospective studies that adjust for confounders and report pregnancy outcomes after symptomatic myoma treatment are needed.

Interventional Uterine-Sparing Therapies for Leiomyomas: A Commentary on Myolysis.

Uterine leiomyomas (myomas, fibroids) are very common in premenopausal women and frequently are associated with abnormal uterine bleeding, bulk effects, and reproductive issues. In women who wish to retain their uterus and/or to enhance or retain fertility, interventional therapies have been introduced, including radiofrequency, laser (chromo), cryotherapy, and magnetic resonance (MR)-guided high-intensity focused ultrasound (MRgHIFU) myolysis. In formulating this commentary, all modalities of myolysis from systematic reviews, randomized controlled clinical trials, and observational studies through December 2018 were reviewed. There are only two treatment modalities available in Canada: the laparoscopic radiofrequency volumetric thermal ablation of fibroids (RFVTA) and MRgHIFU systems. In women who wish to enhance or retain their fertility, the safety and efficacy of radiofrequency and HIFU myolysis have not been clearly established, and these treatments should be offered only after extensive counselling and informed consent. Given the recent concerns regarding the incidence of undiagnosed malignant tumours, the lack of histological confirmation before or after these therapies for symptomatic fibroids mandates a thorough process of informed patient consent before any such interventions.

Occult Leiomyosarcomas in a Canadian Province: A Retrospective Cohort Study.

OBJECTIVE: The risk of unexpected uterine leiomyosarcoma (LMS) following surgery for presumed benign leiomyoma is quoted to be between 1 in 498 and 1 in 5000. The objectives of the present study were to determine the prevalence of uterine LMS in a specific patient population and the rate of diagnosis of occult uterine LMS and to evaluate the risk of unintended morcellation of LMS in Saskatchewan. METHODS: This study was a Canadian Task Force Classification II-2 multicentre retrospective cohort study in academic-affiliated tertiary care centres. All women with the histopathologic diagnosis of uterine LMS in Saskatchewan between January 2000 and December 2014 were included. Women with metastatic LMS at diagnosis or other types of uterine sarcomas were excluded. Data including patients' characteristics, clinical presentation, physical examination findings, imaging, pathology reports, surgical interventions, and survival outcomes were reviewed. RESULTS: A total of 28 patients had a confirmed histopathologic diagnosis of LMS over the 15-year study period. Approximately 26 212 hysterectomies were performed in Saskatchewan over the same time frame. The prevalence of uterine LMS in this patient population over the study time frame is estimated to be one in 853. Mean age at diagnosis was 53.8 ± 10.0. Medical records of 25 patients could be retrieved, and 15 cases (60%) had an occult diagnosis. There were five cases of unintended morcellation (one power, four mechanical). Survival outcomes were comparable in women with unintended morcellation of occult disease and in those without morcellation. CONCLUSION: This study contributes to the existing body of literature on morcellation of occult LMS, and it ascertains the rate of LMS in a patient population. The results of this study provide valuable information to health care professionals, policy makers, and women in Saskatchewan so that they may make more informed decisions concerning uterine masses.

Factors influencing the difficulty of laparoscopic myomectomy: the development of a surgical rating tool.

Objective To obtain expert consensus on the patient and fibroid characteristics that affect the complexity of laparoscopic myomectomy (LM) and to use these factors to create a grading tool for objective evaluation of LM procedures. Study design Modified Delphi Methodology Study (Canadian Task Force III). Setting included a series of online surveys via SurveyMonkey (SurveyMonkey Inc., San Mateo, California, USA). Participants were Canadian minimally invasive gynecologic surgeons (MIGS) who perform LM. A list consisting of patient, uterine and procedural characteristics was disseminated to Canadian MIGS. Opportunity to include additional factors was provided. Consensus was predefined as Cronbach's α of ≥0.80. A second Delphi survey was then done to assign weight value for each item in the grading tool. Results Twenty-seven surgeons from across Canada participated. Most (23/27, 85%) were MIGS fellowship trained, and performed more than 6 LM per year (18/27, 66.7%). Consensus was achieved in the first round of the survey (Cronbach's α = 0.93). Sixteen of 27 factors met the criteria for inclusion (>80% respondents agreed or strongly agreed) and were included in the final rating tool. Factors that met the criteria for inclusion were grouped as patient factors (including body mass index), uterine factors (including number of fibroids, size of largest fibroid), and surgical factors (including ease of developing the cleavage plane). Conclusions Using the Delphi methodology to obtain expert consensus on the factors influencing the difficulty of LM, we have developed an objective grading tool to evaluate the degree of technical complexity of LM.

Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada.

OBJECTIVE: The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate. PATIENTS AND METHODS: Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients' responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work. RESULTS: Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL (p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes (p=0.018), and Lap-RFA required -34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (-44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days (p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD $5,224.96) and myomectomy (CAD $5,321.96). CONCLUSION: Compared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

Diagnosis of adverse events after hysterectomy with postoperative self-care web applications: A pilot study.

Increased pressures from multiple sources are leading to earlier patient discharge following surgery. Our objective was to test the feasibility of self-care web applications to inform women if, when, and where to seek help for symptoms after hysterectomy. We asked 31 women recovering at home after hysterectomy at two centers to sign into a website on a schedule. For each session, the website informed them about normal postoperative symptoms and prompted them to complete an interactive symptom questionnaire that provided detailed information on flagged responses. We interviewed eight women who experienced an adverse event. Six of these women had used the web application regularly, each indicating they used the information to guide them in seeking care for their complications. These data support that self-care applications may empower patients to manage their own care and present to appropriate health care providers and venues when they experience abnormal symptoms.

Laparoscopic Cornuectomy as a Technique for Removal of Essure Microinserts.

STUDY OBJECTIVE: The authors present a laparoscopic technique for complete removal of Essure microinserts (including nitinol coil and positron emission tomography fibers). DESIGN: Step-wise instruction using video. The study was granted a Research Ethics Board exemption because the Regina Qu'Appelle Health Region Research Ethics Board does not require ethics board approval for single case submissions. SETTING: Tertiary care hospital. PATIENTS: Patient requesting removal of Essure inserts because of post-placement discomfort. INTERVENTIONS: Recent concern regarding adverse outcomes (persistent pelvic pain, device malposition, nickel allergy) after Essure placement has led to a small percentage of women requesting removal of the coils. Laparoscopic salpingectomy and salpingostomy have been successfully used for removal. Hysteroscopic removal has been achieved up to 6 weeks after placement; however, because of the fibrosis-inducing mechanism of the inserts, there is theoretical concern regarding fragmentation or incomplete removal with a cut and pull approach. MEASUREMENTS AND MAIN RESULTS: The authors used a laparoscopic surgical approach for removal of the Essure microinserts "en bloc" by performing a salpingectomy and mini-resection of the uterine cornua to the level of the endometrium. This approach ensures complete extraction of the Essure microinserts. The surgery was completed in a tertiary care hospital operating theatre with standard laparoscopic and electrosurgical instruments using a 10-mm infraumbilical port and two 5-mm ports in the left lower quadrant. CONCLUSION: En bloc resection of the fallopian tubes, uterine cornua, and Essure microinserts is a feasible laparoscopic approach to ensure complete removal of Essure microinserts. This approach is technically straightforward and can be achieved with minimal blood loss.

A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. DESIGN: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). SETTING: Thirteen academic and private medical centers. PATIENTS: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). INTERVENTION: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. CONCLUSION: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.

Does Essure Cause Significant De Novo Pain? A Retrospective Review of Indications for Second Surgeries After Essure Placement.

STUDY OBJECTIVES: To examine the surgical indications and pathologic findings in patients undergoing a second surgery after placement of the Essure permanent birth control system to determine the role of Essure in developing new-onset pelvic pain. DESIGN: Retrospective cohort (Canadian Task Force classification II-2). SETTING: Tertiary-level hospital. PATIENTS: Women who have had Essure placement and subsequent second surgery. INTERVENTION: Charts from women undergoing pelvic surgery after Essure placement from June 2002 to June 2013 were reviewed and the indication for the procedure, surgical and pathologic findings noted. MEASUREMENTS AND MAIN RESULTS: Of 1430 patients, 62 (4.3%) had a second surgery after Essure placement, and 24 of these (1.6%) had a surgical indication not related to pain. The remaining 38 patients (2.7%) had either new-onset (n = 27) or worsening pre-existing pain (n = 11). In the new-onset pain group, 15 (1%) had surgical findings or pathology consistent with a painful gynecologic condition. In the remaining 12, 8 (0.5%) seemed to be related to some perforation or migration of the Essure device. In 4 patients (0.3%) with no other obvious cause for the new-onset pain, it was thus attributed to the Essure microinsert. CONCLUSION: Essure sterilization can be associated with new-onset pain or a worsening of a pre-existing painful gynecologic condition, although both are very rare. A careful and complete consent before placement and a thorough examination if pain does occur usually show some etiology for the pain other than the Essure insert.

Confirmation Testing of Essure Microinserts in Unintended Pregnancies Using a 10-Year Retrospective Database.

STUDY OBJECTIVES: To examine the imaging modality used in cases of Essure failures and determine the cause of the unintended pregnancies (noncompliance to follow-up recommendations, misinterpretation of the imaging test, or device failure). DESIGN: Retrospective, single-center interventional cohort (Canadian Task Force classification II-2). SETTING: Tertiary level hospital. PATIENTS: Women who have had Essure placement and subsequent pregnancy. INTERVENTIONS: Coding data from the Regina General Hospital was examined for any pregnancy occurring after an Essure procedure. The hospital charts were then reviewed for data collection. A separate imaging database established over the same time frame was then reviewed to determine the imaging modality used in each case (transvaginal ultrasound [TVU], hysterosalpingogram [HSG], or none). Results of the imaging study were reviewed and the cause of the failure determined. MEASUREMENTS AND MAIN RESULTS: Twenty-four pregnancies in 25 women were identified after Essure procedures from January 1, 2003 to March 31, 2013. There were 4 in vitro fertilization pregnancies and 4 pregnancies where the woman had been instructed not to rely on the devices because of incomplete placement noted at time of the procedure. Therefore, 17 unintended pregnancies occurred of a total 2080 procedures performed. Examination of the imaging studies revealed that 11 were due to patient noncompliance (either early cessation of backup contraception or failure to go for confirmatory imaging), 5 due to misinterpretation of the imaging tests (3 HSG, 2 TVU), and 1 device failure. This reveals a cumulative failure rate of 6 of 2080 or .29% over 10 years with only .04% (1/2080) being device related. CONCLUSION: Essure sterilization is an effective means of permanent contraception with a device failure rate of only .04%. Most unintended pregnancies after the Essure procedure result from a failure to comply with follow-up recommendations, and strategies to improve compliance should be emphasized.

Essure microinsert imaging: does abnormal shape on ultrasound predict complications on HSG?

OBJECTIVE: We hypothesize that the shape of the Essure microinsert on ultrasound is able to predict complications evident on hysterosalpingogram (HSG), the accepted gold standard. METHOD AND MATERIALS: From July 2, 2009 to July 2, 2012, 441 women at our institution received Essure microinsert placement for the purpose of permanent sterilization. 2D and 3D coronal plane transvaginal ultrasounds were performed three months after Essure microinsert placement. Those patients with complications identified on ultrasound, a non-diagnostic ultrasound, or following a difficult insertion were referred for HSG. Patients with both HSG and ultrasound performed were retrospectively selected and anonymized. The ultrasounds were reviewed by a single, blinded radiologist. A total of 122 microinserts in 65 patients were described on ultrasound using a numeric grading system and compared to HSG findings. RESULTS: Microinsert placement resulted in 37 complications, 31 of which were identified on ultrasound, including uterine and tubal perforations and placement in the endometrial cavity. The sensitivity of Essure microinsert shape on ultrasound in predicting complications, compared with standard HSG, was 94%, with a positive predictive value of 85%; specificity was 95%, with a negative predictive value of 98%. The Kappa coefficient was 0.85 (p < 0.001). CONCLUSION: Our results suggest that ultrasound may be used as a frontline imaging modality for patients after Essure microinsert placement.

Comparing technical dexterity of sleep-deprived versus intoxicated surgeons.

BACKGROUND: The evidence on the effect of sleep deprivation on the cognitive and motor skills of physicians in training is sparse and conflicting, and the evidence is nonexistent on surgeons in practice. Work-hour limitations based on these data have contributed to challenges in the quality of surgical education under the apprentice model, and as a result there is an increasing focus on competency-based education. Whereas the effects of alcohol intoxication on psychometric performance are well studied in many professions, the effects on performance in surgery are not well documented. To study the effects of sleep deprivation on the surgical performance of surgeons, we compared simulated the laparoscopic skills of staff gynecologists "under 2 conditions": sleep deprivation and ethanol intoxication. We hypothesized that the performance of unconsciously competent surgeons does not deteriorate postcall as it does under the influence of alcohol. METHODS: Nine experienced staff gynecologists performed 3 laparoscopic tasks in increasing order of difficulty (cup drop, rope passing, pegboard exchange) on a box trainer while sleep deprived (<3 hours in 24 hours) and subsequently when legally intoxicated (>0.08 mg/mL blood alcohol concentration). Three expert laparoscopic surgeons scored the anonymous clips online using Global Objective Assessment of Laparoscopic Skills criteria: depth perception, bimanual dexterity, and efficiency. Data were analyzed by a mixed-design analysis of variance. RESULTS: There were large differences in mean performance between the tasks. With increasing task difficulty, mean scores became significantly (P < .05) poorer. For the easy tasks, the scores for sleep-deprived and intoxicated participants were similar for all variables except time. Surprisingly, participants took less time to complete the easy tasks when intoxicated. However, the most difficult task took less time but was performed significantly worse compared with being sleep deprived. Notably, the evaluators did not recognize a lack of competence for the easier tasks when intoxicated; incompetence surfaced only in the most difficult task. CONCLUSIONS: Being intoxicated hinders the performance of more difficult simulated laparoscopic tasks than being sleep deprived, yet surgeons were faster and performed better on simple tasks when intoxicated.

Evaluation of the NovaSure endometrial ablation procedure in women with uterine cavity length over 10 cm.

OBJECTIVE: To evaluate procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-intervention in women with a sounded uterine length > 10 cm compared to women with a sounded uterine length ≤ 10 cm who underwent the NovaSure endometrial ablation procedure. METHODS: We conducted a retrospective cohort study of 188 women from a Canadian community-based gynaecology practice. Eighty-seven women had a sounded uterine length > 10 cm, and 101 patients had a sounded length ≤ 10 cm. Procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-interventions were compared between groups. RESULTS: Mean uterine sounding lengths were 11.0 ± 0.6 cm and 8.9 ± 0.8 cm in the > 10 cm and ≤ 10 cm groups, respectively. There were no differences between the groups in demographic characteristics or gynaecologic history, with the exception of higher BMI in the > 10 cm group and a greater prevalence of dysmenorrhea in the ≤ 10 cm group. Overall, 44.1% of all participants had been unsuccessfully treated with hormonal therapy, and 20.7% had failed non-hormonal treatment before the ablation procedure. The remaining 35.2% of participants had declined alternative therapy and proceeded directly to endometrial ablation. No serious procedure-related adverse events occurred in either group. Menstrual bleeding status at follow-up at 30.4 ± 15.3 months (> 10 cm group) and 30.5 ± 15.5 months (≤ 10 cm group) was not different between the groups (P = 0.85). In women who did not undergo surgical re-intervention after the initial ablation, amenorrhea was reported by 51.9% in the > 10 cm group and 65.9% in the ≤ 10 cm group. CONCLUSION: The NovaSure endometrial ablation procedure was associated with successful menstrual bleeding outcomes in women with sounded uterine length > 10 cm. No serious procedure-related adverse events occurred, and the need for surgical re-intervention was low. There was no significant difference in bleeding rates between the > 10 cm and ≤ 10 cm uterine length cohorts.

Objectif : Comparer, chez des femmes ayant subi une ablation de l'endomètre au moyen de la technique NovaSure et présentant une longueur utérine déterminée par hystérométrie de plus de 10 cm ou de 10 cm ou moins, les événements indésirables associés à l'intervention, l'état des saignements menstruels à la suite de l'intervention et la nécessité de procéder à une nouvelle intervention chirurgicale. Méthodes : Nous avons mené une étude de cohorte rétrospective qui portait sur 188 femmes ayant fréquenté une pratique gynécologique communautaire au Canada. Quatre-vingt-sept de ces femmes présentaient une longueur utérine déterminée par hystérométrie de plus de 10 cm, tandis que les 101 autres présentaient une longueur utérine déterminée par hystérométrie de 10 cm ou moins. Les événements indésirables associés à l'intervention, l'état des saignements menstruels à la suite de l'intervention et la nécessité de procéder à une nouvelle intervention chirurgicale sont les paramètres qui ont été comparés chez ces deux groupes de femmes. Résultats : Les longueurs utérines moyennes déterminées par hystérométrie ont été de 11,0 ± 0,6 cm et de 8,9 ± 0,8 cm au sein des groupes « > 10 cm ¼ et « ≤ 10 cm ¼, respectivement. Aucune différence n'a été constatée entre les groupes en matière de caractéristiques démographiques ou d'antécédents gynécologiques, exception faite d'un IMC accru au sein du groupe « > 10 cm ¼ et d'une prévalence accrue de dysménorrhée au sein du groupe « ≤ 10 cm ¼. De façon globale, 44,1 % de toutes les participantes avaient connu l'échec de l'hormonothérapie et 20,7 % avaient connu l'échec d'un traitement non hormonal avant la tenue de l'ablation. Les participantes composant les autres 35,2 % avaient refusé d'avoir recours à un traitement de rechange et décidé de subir directement une ablation de l'endomètre. Aucun événement indésirable grave associé à l'intervention ne s'est manifesté dans l'un ou l'autre des groupes. Aucune différence n'a été constatée entre les groupes (P = 0,85) pour ce qui est de l'état des saignements menstruels au moment du suivi à 30,4 ± 15,3 mois (groupe « > 10 cm ¼) et à 30,5 ± 15,5 mois (groupe « ≤ 10 cm ¼). Chez les femmes qui n'ont pas eu à subir une nouvelle intervention chirurgicale à la suite de l'ablation initiale, une aménorrhée a été signalée par 51,9 % des participantes du groupe « > 10 cm ¼ et par 65,9 % des participantes du groupe « ≤ 10 cm ¼. Conclusion : La technique NovaSure d'ablation de l'endomètre a été associée à des issues réussies en matière de saignements menstruels chez les femmes présentant une longueur utérine déterminée par hystérométrie de plus de 10 cm. Aucun événement indésirable grave associé à l'intervention ne s'est manifesté et la nécessité de procéder à une nouvelle intervention chirurgicale était faible. Aucune différence significative n'a été constatée en matière de taux de saignement entre les groupes « > 10 cm ¼ et « ≤ 10 cm ¼.

Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505).

STUDY OBJECTIVE: To assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion. DESIGN: Prospective, single center, interventional cohort (Canadian Task Force classification II-1). SETTING: Tertiary care hospital. PATIENTS: Women scheduled to undergo hysterectomy. INTERVENTION: Patients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement. MEASUREMENTS AND MAIN RESULTS: Thirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects. CONCLUSION: ESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.