Hospital variation in responses to safety warnings about power morcellation in hysterectomy.

BACKGROUND: Safety warnings about power morcellation in 2014 considerably changed hysterectomy practice, especially for laparoscopic supracervical hysterectomy that typically requires morcellation to remove the corpus uteri while preserving the cervix. Hospitals might vary in how they respond to safety warnings and altered hysterectomy procedures to avoid use of power morcellation. However, there has been little data on how hospitals differ in their practice changes. OBJECTIVE: This study aimed to examine whether hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation and compare the risk of surgical complications at hospitals that had different response trajectories in use of laparoscopic supracervical hysterectomy. STUDY DESIGN: This was a retrospective analysis of data from the New York Statewide Planning and Research Cooperative System and the State Inpatient Databases and State Ambulatory Surgery and Services Databases from 14 other states. We identified women aged ≥18 years undergoing hysterectomy for benign indications in the hospital inpatient and outpatient settings from October 1, 2013 to September 30, 2015. We calculated a risk-adjusted utilization rate of laparoscopic supracervical hysterectomy for each hospital in each calendar quarter after accounting for patient clinical risk factors. Applying a growth mixture modeling approach, we identified distinct groups of hospitals that exhibited different trajectories of using laparoscopic supracervical hysterectomy over time. Within each trajectory group, we compared patients' risk of surgical complications in the prewarning (2013Q4-2014Q1), transition (2014Q2-2014Q4), and postwarning (2015Q1-2015Q3) period using multivariable regressions. RESULTS: Among 212,146 women undergoing benign hysterectomy at 511 hospitals, the use of laparoscopic supracervical hysterectomy decreased from 15.1% in 2013Q4 to 6.2% in 2015Q3. The use of laparoscopic supracervical hysterectomy at these 511 hospitals exhibited 4 distinct trajectory patterns: persistent low use (mean risk-adjusted utilization rate of laparoscopic supracervical hysterectomy changed from 2.8% in 2013Q4 to 0.6% in 2015Q3), decreased medium use (17.0% to 6.9%), decreased high use (51.4% to 24.2%), and rapid abandonment (30.5% to 0.8%). In the meantime, use of open abdominal hysterectomy increased by 2.1, 4.1, 7.8, and 11.8 percentage points between the prewarning and postwarning periods in these 4 trajectory groups, respectively. Compared with the prewarning period, the risk of major complications in the postwarning period decreased among patients at "persistent low use" hospitals (adjusted odds ratio, 0.88; 95% confidence interval, 0.81-0.94). In contrast, the risk of major complications increased among patients at "rapid abandonment" hospitals (adjusted odds ratio, 1.48; 95% confidence interval, 1.11-1.98), and the risk of minor complications increased among patients at "decreased high use" hospitals (adjusted odds ratio, 1.31; 95% confidence interval, 1.01-1.72). CONCLUSION: Hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation. Complication risk increased at hospitals that shifted considerably toward open abdominal hysterectomy.

Racial Disparities in Response to a US Food and Drug Administration Safety Communication Regarding the Use of Power Morcellation for the Treatment of Uterine Leiomyoma.

STUDY OBJECTIVE: To investigate whether the rate of increase in the performance of abdominal myomectomy over a laparoscopic approach after the US Food and Drug Administration (FDA) safety communication regarding morcellator use for myomectomy differs among races. DESIGN: Retrospective cohort study. SETTING: The American College of Surgeons National Surgical Quality Improvement data. PATIENTS: Patients aged 18 to 55 years who underwent either laparoscopic or abdominal myomectomy, excluding malignant cases, emergency cases, operations performed by nongynecologic specialists, and cases in which myomectomy was performed during cesarean section. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The odds ratios of abdominal myomectomy over laparoscopic myomectomy before and after the release of the FDA communication were calculated in 3 race categories: white, African American, and other races. In a logistic regression analysis adjusted for possible confounders, including all races, the odds ratio of abdominal myomectomy before and after the FDA communication was 1.30 (95% confidence interval [CI], 1.20-1.41; p <.001). In a logistic regression analysis with a product term of FDA communication exposure and race as a possible effect modifier, the African American population showed a significantly greater change in the odds of abdominal myomectomy over laparoscopic myomectomy in comparison with the white population (1.22; 95% CI, 1.02-1.47; p = .03). In contrast, other races showed no significant change (.83; 95% CI, .64-1.08; p = .17). CONCLUSION: After the FDA communication, the odds ratio of abdominal myomectomy was disproportionately increased in the African American population.

A national survey: Evaluating current practice and risk assessment in morcellation amongst gynaecologists in the United Kingdom.

OBJECTIVE: To evaluate current practice and adherence to AAGL and BSGE power morcellation guidelines. STUDY DESIGN: Cross-sectional survey. SETTING: United Kingdom. PATIENTS/POPULATION: 157 National Health Service (NHS) hospital trusts (organisation comprising of one or more hospitals) offering gynaecological services. INTERVENTION: A questionnaire was emailed between March-July 2018 and completed by Lead/ Directors of Gynaecology within each organisation. Descriptive statistics were used to present results from this study. MEASUREMENTS/RESULTS: We assessed power morcellation practice patterns, informed consent processes and outcomes over the last 12 months. We received 136 responses (87 % response rate). Power morcellation was performed by a third (59, 37.6 %) of all UK hospitals. The median number of gynecologists performing morcellation per organisation was 2 (Q1-Q3: 2-4). A median of 7 morcellators (Q1-Q3: 0-17) were purchased and 7 morcellators (Q1-Q3: 1.25-15.75) used per annum. A median of 10 (Q1-Q3: 2.0-15.0) laparoscopic hysterectomies and 5 (Q1-Q3: 0.5-9.0) myomectomies requiring morcellation were performed per annum. Almost, a third of hospitals did not perform an endometrial biopsy or MRI. 79.7 % (47) of trusts consented for power morcellation and 76 %, (46) explained risk of inadvertent leiomyosarcoma. 83.3 %, (50) had no patient literature and almost half had no audit process 45 %, (27). CONCLUSION: Current UK practice does not reflect recommendations from the AAGL or BSGE. Deficiencies were identified in pre-operative evaluation, local governance procedures, and consenting practices regarding use of a power morcellator and risk of occult leiomyosarcoma.

Reduced Complications Following Implementation of Laparoscopic Hysterectomy: A Danish Population-based Cohort Study of Minimally Invasive Benign Gynecologic Surgery between 2004 and 2018.

STUDY OBJECTIVE: To monitor and report nationwide changes in the rates of and complications after different methods for benign hysterectomy, operative hysteroscopy, myomectomy, and embolization in Denmark. To report the national mortality after benign hysterectomy DESIGN: National prospective, observational cohort study. SETTING: The Danish Hysterectomy and Hysteroscopy Database. PATIENTS: Women undergoing surgery for benign gynecologic diseases: 64 818 hysterectomies, 84 175 hysteroscopies, 4016 myomectomies, and 1209 embolizations in Denmark between 2004 and 2018. INTERVENTIONS: National meetings with representatives from all departments, annual working reports of institutional complication rates, workshops, and national guideline initiative to improve minimally invasive surgical methods. MEASUREMENTS AND MAIN RESULTS: Rates of the different methods and complications after each method with follow-up to 5 years as recorded by the database directly in the National Patient Registry. Nationwide, a decline in the use of hysterectomy, myomectomy, embolizations, and endometrial ablation. The total short-term complications were 9.8%, 7.5%, 8.9%, and 2.7% respectively, however, with a persistent risk of approximately 20% for recurrent operations within 5 years after endometrial ablation. Initially, we urged for increased use of vaginal hysterectomy, but only reached 36%. From 2010, we urged for reducing abdominal hysterectomies by implementing laparoscopic hysterectomy and reached 72% laparoscopic and robotic procedures. Since 2015, we used coring or contained morcellation for removal of large uterus at laparoscopic hysterectomy. The major and minor complication rates (modified Clavien-Dindo classification) were reduced significantly from 8.1% to 4.1% and 9.9% to 5.7% respectively. Mortality after benign hysterectomy was 0.27‰. The odds ratio for major complications after abdominal hysterectomy was 1.66 (1.52-1.81) compared to minimally invasive hysterectomy independent of the length of stay, high-volume departments, indications, comorbidity, age, and calendar year. CONCLUSION: Fifteen years with a national database has resulted in a marked quality improvement. Denmark has 85% minimally invasive hysterectomies and has reduced the number of major complications by 50%.

Non-malignant Sequelae after Unconfined Power Morcellation.

STUDY OBJECTIVE: To identify the incidence of repeat surgery and subsequent findings after the performance of unconfined uterine power morcellation. DESIGN: A retrospective descriptive study (Canadian Task Force classification II-2). SETTING: Southern California Kaiser Permanente Medical Centers. PATIENTS: Women (N = 5154) who underwent laparoscopic supracervical hysterectomy with unconfined power morcellation. MEASUREMENTS AND MAIN RESULTS: Of the 5154 cases, 279 (5.41%) underwent subsequent reoperation with a median of 24 months after index surgery. The most common clinical complaint leading to laparoscopic supracervical hysterectomy was symptomatic leiomyoma (n = 135, 48.4%) and abnormal uterine bleeding (n = 94, 33.7%). The most common indication for reoperation was a symptomatic adnexal mass (n = 87, 31.2%) followed by pelvic pain (n = 83, 29.7%). The majority (n = 128, 60.4%) of subsequent non-urogynecologic-related reoperations resulted in benign pathology. Endometriosis was the primary pathologic diagnosis in 65 of 279 (23.3%) of the reoperative cases; this was not previously documented in 86% (n = 57/65) of these cases. The overall frequency of subsequent pathology was endometriosis (65/5154, 1.26%), disseminated leiomyomatosis (18/5154, 0.35%), and new malignancy (11/5154, 0.21%). CONCLUSION: Morcellation of nonmalignant tissue is not without consequence. Pathology confirmed endometriosis was documented for the first time in 20.4% of patients who underwent a second surgery. This finding raises the suspicion that morcellation and dispersion of the uterine specimen may be associated in the development of endometriosis.

Practice Patterns and Complications of Benign Hysterectomy Following the FDA Statement Warning Against the Use of Power Morcellation.

Importance: In November 2014, the US Food and Drug Administration (FDA) issued a black box warning against the use of power morcellation for excision of uterine fibroids to decrease the risk of disseminating malignant cells and worsening survival outcomes of patients with unexpected malignant neoplasms. After the FDA statement was issued, studies showed decreased rates of minimally invasive surgery and increased rates of open abdominal hysterectomy. However, there are limited and controversial data on the association of these changed rates with 30-day hysterectomy complications. Objective: To assess changes in the rates of 30-day major and minor complications of hysterectomy for benign gynecologic indications following the FDA-issued statement. Design, Setting, and Participants: This retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program database and included 603 hospitals participating between January 1, 2013, and December 31, 2015. Thirty-day posthysterectomy complications were compared before and after the FDA-issued warning. Women who underwent hysterectomy for benign gynecologic indications (n = 75 487), including hysterectomies with indication of uterine fibroids (n = 25 571), were included. Complication rates and procedure distributions between the periods were compared with χ2 tests and multivariable logistic regression controlling for patient and operative factors. Main Outcomes and Measures: Major and minor 30-day complication rates before (from 2013 through the first quarter of 2014) and after (from the fourth quarter of 2014 through 2015) the FDA-issued warning. Results: Of 75 487 women (mean [SD] age, 47.8 [10.7] years) who underwent hysterectomy for benign gynecologic indications, 32 186 (42.6%) were treated before and 43 301 (57.4%) after the FDA-issued warning. Non-Hispanic white women comprised most (59.4%) of the total population, followed by African American women (15.1%). Overall, major and minor complications remained stable before and after the FDA-issued warning. By contrast, among a subset of 25 571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01). In this subgroup, the rate of open abdominal surgery increased from 37.2% to 43.0%, and the rate of minimally invasive surgery (total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, and laparoscopic-assisted vaginal hysterectomy) decreased from 56.1% to 49.7% (P < .001). Conclusions and Relevance: Major and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement. This increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation during a shared decision-making process between clinician and patient. Regulatory bodies and medical societies should consider these findings when issuing relevant communications.

Prevalence of occult leiomyosarcomas and atypical leiomyomas after laparoscopic morcellation of leiomyomas in reproductive-age women.

STUDY QUESTION: What is the prevalence of leiomyosarcomas and atypical leiomyomas after laparoscopic morcellation of fibroids in reproductive age women? SUMMARY ANSWER: No case of leiomyosarcomas but seven atypical leiomyomas were found in 1216 subjects. WHAT IS KNOWN ALREADY: Although uterine sarcoma is a rare entity affecting usually older peri- or post-menopausal women, the Food and Drug Administration discourages use of laparoscopic power morcellation of uterine fibroids. STUDY DESIGN, SIZE, DURATION: Retrospective review of data extracted from a single center database of 1216 consecutive women who underwent laparoscopic morcellation of 2582 unsuspicious leiomyomas between June 2003 and December 2015 and were followed-up until December 2016. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: A total of 1216 women, aged 18-45 years, underwent laparoscopic morcellation of 2582 apparently benign leiomyomas by the same surgeon and all specimen slides were examined by the same experienced pathologist. MAIN RESULTS AND THE ROLE OF CHANCE: The prevalence of leiomyosarcomas and atypical leiomyomas was 0% (95% CI: 0-0.3%) and 0.6% (95% CI: 0.23-1.18%) (six atypical-bizarre and one mitotically active leiomyoma) respectively. In addition, there were identified 34 cases of adenomyomas, 45 leiomyomas with infarcts, 81 cellular leiomyomas and 133 degenerated leiomyomas. No morcellator-associated complication was recorded and none of the patients included in this study required conversion to laparotomy. LIMITATIONS, REASONS FOR CAUTION: Retrospective and single referral center study design. WIDER IMPLICATIONS OF THE FINDINGS: Laparoscopic morcellation of unsuspicious leiomyomas after careful preoperative work up seems to be safe in women of reproductive age. STUDY FUNDING/COMPETING INTEREST(S): None.

Minimally Invasive Hysterectomy and Power Morcellation Trends in a West Coast Integrated Health System.

OBJECTIVE: To examine trends in minimally invasive hysterectomy and power morcellation use over time and associated clinical characteristics. METHODS: We conducted a trend analysis and retrospective cohort study of all women 18 years of age and older undergoing hysterectomy for benign conditions at Kaiser Permanente Northern California collected from electronic health records. Generalized estimating equations and Cochran-Armitage testing were used to assess the primary outcomes, hysterectomy incidence, and proportion of hysterectomies by surgical route and power morcellation. Logistic regression analysis was used to assess secondary outcomes, clinical characteristics, and complications associated with surgical route. RESULTS: There were 31,971 hysterectomies from 2008 to 2015; the incidence decreased slightly from 2.86 (95% confidence interval [CI] 2.85-2.87) to 2.60 (95% CI 2.59-2.61) per 1,000 women (P<.001). Minimally invasive hysterectomies increased from 39.8% to 93.1%, almost replacing abdominal hysterectomies entirely (P<.001). Vaginal hysterectomies decreased slightly from 26.6% to 23.4% (P<.001). The proportion of nonrobotic laparoscopic hysterectomies with power morcellation increased steadily from 3.7% in 2008 to a peak of 11.4% in 2013 and decreased to 0.02% in 2015 (P<.001). Robot-assisted laparoscopic hysterectomies remained a small proportion of all hysterectomies comprising 7.8% of hysterectomies in 2015. Women with large uteri (greater than 1,000 g) were more likely to receive abdominal hysterectomies than minimally invasive hysterectomy (adjusted relative risk 11.62, 95% CI 9.89-13.66) and laparoscopic hysterectomy with power morcellation than without power morcellation (adjusted relative risk 5.74, 95% CI 4.12-8.00). Laparoscopic supracervical hysterectomy was strongly associated with power morcellation use (adjusted relative risk 43.89, 95% CI 37.55-51.31). CONCLUSION: A high minimally invasive hysterectomy rate is primarily associated with uterine size and can be maintained without power morcellation.

Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation.

OBJECTIVE: To examine the association between the 2014 U.S. Food and Drug Administration (FDA) safety communication on power morcellation and surgical approach and morbidity after myomectomy. METHODS: In this retrospective cohort study, data were abstracted from the American College of Surgeons National Surgical Quality Improvement Program database on 3,160 myomectomies between April 2012 and December 2013 (pre-FDA) and 4,378 between April 2014 and December 2015 (post-FDA). Aims were to 1) compare rates of abdominal and laparoscopic myomectomy pre-FDA and post-FDA (primary outcome), 2) directly compare the morbidity of abdominal and laparoscopic myomectomy during each time period (secondary outcome 1), and 3) compare the morbidity after all myomectomies performed pre-FDA and post-FDA (secondary outcome 2). Adjusted means, odds ratios, and rate ratios with 95% confidence intervals were calculated using linear, logistic, and Poisson regression, respectively, adjusting for age, race, ethnicity, body mass index, and myoma burden. RESULTS: Myomectomies performed post-FDA were more likely to be abdominal (60.0%, 95% confidence interval [CI] 58.6-61.5%) than laparoscopic (40.0%, 95% CI 38.5-41.4%) as compared with myomectomies pre-FDA, which were equally divided between surgical approaches (49.1% abdominal, 95% CI 47.4-50.9% compared with 50.9% laparoscopic, 95% CI 49.1-52.6%; P<.001). When directly compared with laparoscopic myomectomy, abdominal myomectomy was associated with longer hospitalizations, higher readmission rates, and greater morbidity both pre-FDA and post-FDA (P<.05, all comparisons). Adjusted models demonstrated shorter operative times post-FDA for all myomectomies (P<.001), although composite morbidity was similar between myomectomies performed pre-FDA and post-FDA (P=.809). CONCLUSIONS: The FDA safety communication on power morcellation was associated with an 11% absolute increase in the use of abdominal myomectomy. Although morbidity is consistently higher after abdominal as compared with laparoscopic myomectomy, the increased reliance on abdominal myomectomy post-FDA did not result in clinically significant changes in morbidity in this cohort.

Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

OBJECTIVE: To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines. METHODS: This is a retrospective review of all patients who underwent a hysterectomy for benign indications, specifically for leiomyomas, at Brigham and Women's Hospital from 2013 to 2015. The rates of abdominal, vaginal, laparoscopic, and robotic-assisted laparoscopic hysterectomy as well as the perioperative outcomes were compared over the study period. Analysis was performed using multivariable linear, multinomial, and logistic regression. Regression models were adjusted for potential confounders. RESULTS: From 2013 to 2015, 1,530 patients underwent a hysterectomy for benign indications and 639 patients underwent the procedure for the indication of uterine leiomyomas; there was a decrease in the number of hysterectomy cases in the later years. Focusing on the patients with leiomyomas alone, there was a 40-60% decreased odds of a minimally invasive procedure in 2014 or 2015 compared with 2013 [adjusted odds ratio (OR) 0.53 (0.29-0.97) in 2014 and adjusted OR 0.40 (0.22-0.74) in 2015, P=.003]. A 24% decrease in the supracervical approach to hysterectomy was also noted. Despite these trends, the majority of cases in each year were still performed in a minimally invasive fashion. The factor most strongly associated with undergoing a minimally invasive hysterectomy was having a fellowship-trained surgeon perform the procedure [adjusted OR 6.80 (3.65-12.7), P<.001]. There was no significant difference between the year of surgery and occurrence of intraoperative complications or reoperation. CONCLUSION: Although key perioperative outcomes remained similar, the overall rate of minimally invasive surgery declined at our institution after the FDA's recommendations. With changing practice patterns and vigilance surrounding power morcellation, gynecologic surgeons may still offer patients minimally invasive procedures with all of the accompanying advantages.

Minilaparotomy Versus Laparoscopic Myomectomy After Cessation of Power Morcellation: Rate of Wound Complications.

STUDY OBJECTIVE: After the US Food and Drug Administration statement warning against electronic morcellation devices, gynecologic surgeons are performing laparoscopic and robotic myomectomies with minilaparotomy incisions for tissue morcellation and removal. No data exist that focus on the superficial wound complications as a result of these larger incisions. The objective of this study is to compare the rate of wound complications for myomectomy via minilaparotomy versus laparoscopic or robotic myomectomy. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Kaiser Permanente Northern California, a large integrated healthcare delivery system. PATIENTS: Women > 18 years of age who underwent a myomectomy from either complete laparoscopic or robotic approach (LR) were compared with minilaparotomy myomectomy (MM), comprising complete minilaparotomy (ML) and laparoscopic or robotic assisted by a minilaparotomy for morcellation purposes only (LRM) from January 2011 through December 2014. INTERVENTION: Myomectomy via LR, complete ML, and LRM. MEASUREMENTS AND MAIN RESULTS: Medical records were reviewed for outcomes of interest, including superficial wound complications and surgical and demographic data. After exclusion criteria were met, 405 cases were included in the study; 270 cases were classified as MM, which included ML (n = 224), or LRM (n = 46). One hundred thirty-five cases were classified as LR. Parametric and nonparametric analyses were used to compare the 2 groups. There was no significant difference between the groups insofar as patient morbidity, including the primary outcome of wound complications and other postoperative complications; emergency visits; or readmissions. There were 2 (1.5%) wound complications in the LR group and 7 (2.6%) in the MM group (p = .72). Similarly, there were no significant differences in the subcategories of wound complications, including cellulitis, seroma, hematoma, skin separation, wound infection, or postprocedure wound complication. The distribution of estimated blood loss was significantly different between LR and MM groups with an interquartile range of 50 to 150 mL in the LR group versus 50 to 300 mL in the MM group (p < .01). The MM group experienced a shorter procedure time with a median procedure time of 125 minutes compared with 169.5 minutes in LR surgeries (p < .01). The LR group demonstrated a significantly shorter median length of hospital stay (LR 5.0 hours vs MM 23 hours; p < .01). CONCLUSION: Compared with MM, LR is associated with a shorter length of hospital stay and longer operating time but no reduction in wound complication or other patient morbidity.

To Morcellate or Not to Morcellate: A Cross-Sectional Survey Of Gynecologic Surgeons.

BACKGROUND AND OBJECTIVES: The inadvertent dissemination of uterine cancer cells with the power morcellator has received much attention in the press and a warning from the U.S. Food and Drug Administration. Many hospitals prohibit the use of the morcellator in gynecologic surgery. We conducted a survey in an attempt to assess gynecologic surgeons' beliefs regarding the intracorporeal power morcellation of fibroids in light of the risk of dissemination of malignancy in patients in whom the presence of cancer is unknown before surgery. METHODS: We conducted an Internet-based survey of 3505 members of the Society of Laparoendoscopic Surgeons (SLS) to assess demographics, current use of the intracorporeal power morcellator, and whether the recent negative press has affected gynecologic surgeons' use of the morcellator. RESULTS: Of the 3505 SLS members surveyed, 518 responded (response rate, 14.77%). Three hundred thirteen (61%) of the respondents were not using the intracorporeal power morcellator. Of those, 48% reported the reason was a hospital-wide ban, and an additional 17% reported lack of availability (not in stock). Senior attendings with >20 years of experience used the morcellator more often than junior attendings and fellows (P = .007). Furthermore, the morcellator was used significantly less among those with the belief that morcellation of occult malignancy affects survival (P = .013). Three hundred sixty-one (76%) of the participants currently perform laparotomy in fewer than a quarter of their cases; most those cases are still performed using laparoscopic and robot-assisted techniques. CONCLUSION: The recent negative press suggesting that intracorporeal power morcellation can disseminate occult malignancy and affect survival has decreased the use of the morcellator. Despite the declining use of power morcellation, most practicing gynecologic surgeons have not converted their procedures to laparotomy.

Incidence of Malignancy and Myoma Variants at Surgery for Presumed Benign Symptomatic Myomas.

STUDY OBJECTIVE: To estimate the incidence of leiomyosarcoma; other uterine pathologies; and the frequency of use of morcellation, both mechanical and manual in laparoscopic, vaginal, and laparotomy operative routes in women undergoing hysterectomy or myomectomy for benign gynecologic indications when myomas were present. DESIGN: A retrospective study (Canadian Task Force classification II-3). SETTING: The Royal Women's Hospital, Melbourne, Australia. PATIENTS: All hysterectomies and myomectomies (any route) for a 10-year period from January 1, 2004, to December 31, 2013, for presumed benign gynecologic indications. INTERVENTIONS: Hysterectomy or myomectomy, any route. MEASUREMENTS AND MAIN RESULTS: From January 1, 2004, to December 31, 2013, a total of 2790 hysterectomies and myomectomies were performed for presumed benign disease. Myomas were present in 1878 cases. There were no cases of leiomyosarcoma identified, giving an incidence of 0% (95% confidence interval, 0%-0.20%). There were 73 (4%) cases of benign variants, of which 2 (3%) displayed metastatic behavior. There were 11 cases of unexpected malignancy (0.6%). CONCLUSION: There were no confirmed cases of leiomyosarcoma over the 10-year period in women requiring surgery for presumed benign disease in the presence of myomas. There was a low but significant rate of unexpected gynecologic malignancy and a higher than expected rate of clinically significant adverse outcomes with manually morcellated cellular myoma variants.

Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis.

This systematic review and meta-analysis compares hysteroscopic morcellation with electrosurgical resection to treat uterine cavitary lesions. A search of Ovid MEDLINE, Ovid Embase, Scopus, and Web of Science was conducted through August 18, 2015, for randomized controlled trials (RCTs) and prospective and retrospective studies, regardless of surgical indication and study language or sample size. Seven studies were eventually included (4 RCTs and 3 retrospective observational studies), enrolling 650 women. The meta-analysis showed that the total procedure time was significantly shorter for morcellation than for resection (weighted mean difference = 9.36 minutes; 95% confidence interval [CI], -15.08 to -3.64). When reviewing RCTs only, intrauterine morcellation was associated with a smaller fluid deficit and lower odds of incomplete lesion removal. This difference was not statistically significant in observational studies. There was no significant difference in the odds of surgical complications (odds ratio = 0.72; 95% CI, 0.20-2.57) or the number of insertions (weighted mean difference = -3.04; 95% CI, -7.86-1.78). In conclusion, compared with hysteroscopic resection, hysteroscopic morcellation is associated with a shorter operative time and possibly lower odds of incomplete lesion removal. The certainty in evidence was limited by heterogeneity and the small sample size.

Prognostic Factors for Morcellation During Vaginal Hysterectomy.

OBJECTIVE: To determine prognostic factors associated with cold-knife morcellation during vaginal hysterectomy. METHODS: We conducted a retrospective cohort study evaluating all consecutive patients undergoing a vaginal hysterectomy between January 1, 2009, and August 31, 2014. The primary outcome was the utilization of uncontained vaginal morcellation performed using cold-knife wedge resection at the time of vaginal hysterectomy. Secondary outcomes included perioperative data. Significant factors were included in a multivariate logistic regression model to the binary variable vaginal morcellation at the time of vaginal hysterectomy. RESULTS: A total of 743 women met study inclusion criteria and underwent vaginal hysterectomy with intact uterine removal (n=383) or with uterine morcellation (n=360) with and without other vaginal procedures. A nonparametric Wilcoxon-rank-sum test and χ test were used to compare the cohorts of patients with and without morcellation. Characteristics associated with significantly increased likelihood of morcellation included younger age, non-Caucasian race, American Society of Anesthesiologists class 1 or 2, lower parity, lower number of prior vaginal deliveries, absence of prolapse, presence of leiomyoma, and an enlarged uterus. A multivariate logistic model utilizing factors most likely associated with morcellation revealed lack of prolapse (adjusted odds ratio [OR] 3.87, P<.001), leiomyoma (adjusted OR 2.77, P=.035), and larger uterine weight (adjusted OR 7.25, P<.001) increased the likelihood of morcellation. Prior vaginal delivery was associated with a decreased likelihood of morcellation (adjusted OR 0.79, P=.005). CONCLUSION: Vaginal hysterectomy with morcellation is associated with the following factors: absence of prior vaginal delivery, absence of prolapse, presence of leiomyoma, and a uterus larger than normal size.

Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection.

INTRODUCTION: Hysteroscopic management of submucosal fibroids using the intrauterine morcellation technique is increasingly being adopted worldwide but no literature concerning its safety and efficacy is available within our local population. We aimed to determine the safety, satisfaction, and efficiency of hysteroscopic intrauterine morcellation of submucosal fibroids, and to compare this technique with conventional hysteroscopic monopolar loop resection to identify its potential benefits. METHODS: All cases of hysteroscopic resection of submucosal fibroids performed in a regional hospital in Hong Kong between 1 January 2011 and 31 December 2014, either by hysteroscopic intrauterine morcellation (MyoSure; Hologic, Bedford [MA], US) or conventional hysteroscopic monopolar loop resection, were selected and case notes reviewed. Technical details such as fibroid size, operating time, fluid deficit, operative complications, patient satisfaction, and improvement in haemoglobin level were analysed and compared between the hysteroscopic intrauterine morcellation and the conventional groups. All statistical results were calculated using the Mann-Whitney test. RESULTS: During the 3-year period, 29 cases of submucosal fibroids were managed by hysteroscopic surgery. Conventional hysteroscopic monopolar loop resection was performed in 14 patients and another 15 underwent hysteroscopic intrauterine morcellation with the MyoSure device. At 3-month follow-up, there was no significant difference in overall patient satisfaction (84.6% for conventional method vs 93.3% for hysteroscopic intrauterine morcellation method; P=0.841). Both techniques showed improvement in haemoglobin level at 3 months but without significant difference between the two groups: +21.5 g/L (+1 to +44 g/L) for conventional group and +17.0 g/L (-4 to +40 g/L) for hysteroscopic intrauterine morcellation group (P=0.235). Both techniques achieved 100% satisfaction if the submucosal fibroid had over 60% of its contents protruding into the uterine cavity. The operating time was significantly reduced for the hysteroscopic intrauterine morcellation technique (mean, 36.6 mins vs 53.6 mins in conventional hysteroscopic monopolar loop resection; P=0.005), particularly in those whose fibroids were ≤3.0 cm (mean, 27.6 mins vs 53.4 mins; P=0.019). CONCLUSIONS: This retrospective review suggests that hysteroscopic intrauterine morcellation of submucosal fibroids is a safe and effective method in the management of menorrhagia in Chinese women. Preliminary data suggest this technique to be less time-consuming, especially when managing fibroids of ≤3.0 cm.

Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy.

OBJECTIVE: To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas. METHODS: We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period. RESULTS: There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns. CONCLUSION: There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation. LEVEL OF EVIDENCE: II.

[Hysterectomy for benign gynaecological disease: Surgical approach, vaginal suture method and morcellation: Guidelines]. / Hystérectomie pour pathologie bénigne: choix de la voie d'abord, technique de suture vaginale et morcellement: recommandations.

OBJECTIVE: To provide clinical practice guidelines from the French college of obstetrics and gynaecology (CNGOF), based on the best evidence available, concerning the surgical approach, the vaginal suture method, the surgeon's experience and morcellation to avoid complications with hysterectomy for benign gynaecological disease. MATERIAL AND METHODS: English and French review of literature about complications with hysterectomy for benign gynaecological disease, excluding cancer. RESULTS AND CONCLUSION: For benign gynaecological disease, vaginal (VH) or laparoscopic (LH) hysterectomy are recommended (grade B). In case of big uterus, VH or LH are recommended (grade C). VH is not contraindicated in nulliparous (Grade C). VH is not contraindicated in case of previous caesarean (grade C). In obese women, VH and LH are recommended (grade C). It should be recommended to perform at least 30 hysterectomies during learning curve (grade C). Hysterectomy should be performed by surgeon doing at least 10 hysterectomies each year (grade C). No vaginal suture method is recommended (grade C). It is recommended to assess cancer risk before (histological sample and/or imagery) when morcellation is planned (expert opinion).

Uncontained Compared With Contained Power Morcellation in Total Laparoscopic Hysterectomy.

OBJECTIVE: To compare perioperative outcomes of uncontained and contained power morcellation in total laparoscopic hysterectomy. METHODS: Women who underwent total laparoscopic hysterectomy that required utilization of power morcellation between July 2012 and January 2015 in the Division of Minimally Invasive Gynecology at an academic tertiary care center were included. In February 2014, the division began performing all power morcellation contained within a large insufflated bag in an attempt to reduce dissemination of benign and malignant uterine tissue. Data were collected from a prospective database and analyzed as a retrospective cohort. The primary outcome was operative time. Secondary outcomes included estimated blood loss, length of stay, pathology, uterine weight, and complications, including blood transfusion, conversion to open, intraoperative organ injury, pelvic infection, readmission, or reoperation. RESULTS: A total of 152 patients were identified: 101 uncontained morcellations and 51 contained morcellations. The baseline demographic characteristics between the two groups were similar. Operative time was longer in the contained morcellation group (184 compared with 164 minutes, P=.01). There were no cases of visible bag disruption or dissemination of uterine tissue in the contained morcellation group. CONCLUSION: Contained power morcellation at the time of total laparoscopic hysterectomy is associated with a 20-minute increase in operative time when compared with uncontained morcellation. LEVEL OF EVIDENCE: II.