In-bag abdominal manual morcellation versus contained power morcellation in laparoscopic myomectomy: a comparison of surgical outcomes and costs.

BACKGROUND: To compare the surgical outcomes and costs of in-bag abdominal manual morcellation (AMM) and contained power morcellation (PM) in laparoscopic myomectomy. METHODS: A total of 61 patients were divided into two groups based on their myomectomy specimen extraction methods: AMM group (n = 33) and electromechanical contained PM group (n = 28). The surgical outcomes and cost were compared between groups. During AMM, a glove bag (in 27 patients) and an endo bag were used (in 6 patients) according to the myoma size. RESULTS: Morcellation time (18 ± 9.2 min vs. 37.4 ± 14.1 min) and total operation time (100 ± 24.3 min vs. 127 ± 33.1 min) were significantly lower in the AMM group compared to those in the PM group. Other surgical outcomes, which were similar between groups, included delta hemoglobin, length of hospital stay and VAS score at 12 and 24 h postoperatively. There were no per- or postoperative complications in both group with no conversion to laparotomy. One patient was transfused with two units of erythrocyte suspension postoperatively in the PM group. Sarcoma was not diagnosed in any of the cases in both group. CONCLUSION: The in-bag AMM or contained PM for specimen extraction resulted in similar outcomes in terms of delta hemoglobin, postoperative pain intensity (VAS score at 12 and 24 h postoperatively), the need for additional analgesia, and the length of hospital stay; however, total operation time and morcellation time were significantly shorter in the AMM group, indicating a prominent advantage. Significant cost-effectiveness is also a critical advantage of in-bag AMM compared to containing PM.

In Vitro User Assessment of a Novel Wound Protection and Specimen Extraction System for Laparoscopic Procedures Involving Morcellation.

INTRODUCTION: The risk of unknowingly disseminating leiomyosarcoma by morcellation in women undergoing laparoscopic hysterectomy has massively impacted gynaecological practice. Here, we present the results of an in vitro assessment of a novel protection system developed to mitigate this hazard. METHODS: The Tissue Containment System for Manual Morcellation (Guardenia™, Advanced Surgical Concepts, Wicklow, Ireland) is an evolved wound protection/specimen extraction guarded bag system compatible with any 12mm trocar. Device use was assessed by device-naïve gynaecological and general surgeon volunteers (providing expert and inexpert morcellation cohorts, respectively) on a bench model consisting of biological tissue in a custom-built moulded rig with camera control after the operators were instructed in its use. RESULTS: Twenty surgeons (10 gynaecologists/10 general surgeons, median duration of practice experience: 8 years, median annual number of laparoscopic operative procedures: 150 and 80, respectively) completed the user assessment. All subjects understood and correctly performed each step; i.e., (i) placement of the bag through the trocar, (ii) specimen bagging, (iii) incision extension (range 25-60 mm) after tethering the bag through the port, (iv) insertion of the device guard through the mouth of the bag after trocar removal, and (v) sufficient tissue morcellation within the bag to enable complete specimen removal (mean specimen weight 390g, range 201-1800g). There was 100% bag integrity by water-leak testing following use, despite scalpel contact with the guard in 14/20 cases (70%). CONCLUSION: Among first-time clinical users, this novel device enabled complete containment of morcellation debris and removal of a laparoscopic specimen, which would support further submission for regulatory approval.

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.

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.

The impact of recent power morcellator risk information on inpatient surgery and patient outcomes.

Aim: We examine the impact of the new risk information about a surgical device on surgery and patient outcomes for hysterectomy in the inpatient setting. Methods: We utilize a difference-in-differences approach to assess the impact of new risk information on patient outcomes in the inpatient setting between 2009 and 2014. The inpatient data come from a nationally representative sample of hospitalizations in the USA. We use the likelihood of laparoscopic surgery, measures of resource use and surgical complications as outcome variables. Results: We estimate a three-percentage point decrease in the likelihood of receiving laparoscopic hysterectomy, a one-percentage point increase in the likelihood of experiencing a surgical complication and no impact on resource use, relative to pre-existing means. Conclusion: Our findings show that there was movement away from laparoscopic surgery in the months following the dissemination of new risk information. These changes had limited effect on patient outcomes.

No. 371-Morcellation During Gynaecologic Surgery: Its Uses, Complications, and Risks of Unsuspected Malignancy.

OBJECTIVE: This guideline provides guidance to gynaecologists regarding the use of tissue morcellation in gynaecologic surgery. OUTCOMES: Morcellation may be used in gynaecologic surgery to allow removal of large uterine specimens, thus providing women with a minimally invasive surgical option. Adverse oncologic outcomes of tissue morcellation should be mitigated through improved patient selection, preoperative investigations, and novel techniques that minimize tissue dispersion. EVIDENCE: Published literature was retrieved through searches of PubMed and Medline in the spring of 2014 using appropriate controlled vocabulary (leiomyosarcoma, uterine neoplasm, uterine myomectomy, hysterectomy) and key words (leiomyoma, endometrial cancer, uterine sarcoma, leiomyosarcoma, and morcellation). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date limits, but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to July 2017. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the report of the Canadian Task Force on Preventive Health Care. BENEFITS, HARMS, AND COSTS: Gynaecologists offer women minimally invasive surgery, and this may involve tissue morcellation and the use of a power morcellator for specimen retrieval. Women should be counselled that in the case of unexpected uterine (sarcoma, endometrial), cervical, and/or tubo-ovarian cancer, the use of a morcellator is associated with increased risk of tumour dissemination. Tissue morcellation should be performed only after complete investigation, appropriate patient selection, and informed consent and by surgeons with appropriate training in the safe practices of tissue morcellation. SUMMARY STATEMENTS: RECOMMENDATIONS.

Economics of gynecologic morcellation.

PURPOSE OF REVIEW: As the Food and Drug Administration raised concern over the power morcellator in 2014, the field has seen significant change, with patients and physicians questioning which procedure is safest and most cost-effective. The economic impact of these decisions is poorly understood. RECENT FINDINGS: Multiple new technologies have been developed to allow surgeons to continue to afford patients the many benefits of minimally invasive surgery while minimizing the risks of power morcellation. At the same time, researchers have focused on the true benefits of the power morcellator from a safety and cost perspective, and consistently found that with careful patient selection, by preventing laparotomies, it can be a cost-effective tool. SUMMARY: Changes since 2014 have resulted in new techniques and technologies to allow these minimally invasive procedures to continue to be offered in a safe manner. With this rapid change, physicians are altering their practice and patients are attempting to educate themselves to decide what is best for them. This evolution has allowed us to refocus on the cost implications of new developments, allowing stakeholders the opportunity to maximize patient safety and surgical outcomes while minimizing cost.

A Survey of Morcellator Preference and Cost Comparison of the Lumenis VersaCut and Wolf Piranha Morcellators.

OBJECTIVE: To evaluate operating room (OR) costs associated with the 2 available morcellators in the United States in a matched cohort and to determine benign prostatic hyperplasia surgeon's morcellator preference. MATERIALS AND METHODS: Patients from 2013, the last year our institution exclusively used the VersaCut device, were matched 1:1 with the most recent patient cohort, utilizing the Wolf Piranha morcellator. Cost of morcellation including the expense of OR time and disposable instrument costs were calculated. A survey to the Endourological Society e-mail listserv was sent to determine morcellator preference. RESULTS: We identified 142 patients who underwent holmium laser enucleation of the prostate in 2013. When compared with the VersaCut group, morcellation efficiency (4.4 vs 7.0 g/min, P <.01) and expense of OR time ($1420.80 vs $992.21, P <.005) both favored the Piranha morcellator system even when the costs of disposable instruments were factored into the analysis ($1338.81 vs $1637.50, P <.05). A total of 126 urologists responded to the survey. Of these, 56 (44.5%) perform transurethral prostate enucleations, which included 48 (86%) holmium. More endourologists use the VersaCut (n = 33, 59%) than the Piranha (n = 24, 43%) morcellator. Qualities that impacted the preference of morcellator included the preferred device is safer, faster, easier to use, reusable, and less expensive. CONCLUSION: We identified a significant improved efficiency and improved cost savings utilizing the Piranha morcellator even when controlling for disposable costs. Of the endourologists who responded to the survey, less than half perform transurethral enucleation. Morcellator preference is largely based on safety, efficiency, and ease of use, whereas cost and reusablility were of lesser importance.

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.

Three-dimensional transvaginal sonographic assessment of uterine volume as preoperative predictor of need to morcellate in women undergoing laparoscopic hysterectomy.

OBJECTIVE: In light of recent statements from the United States Food and Drug Administration warning against the use of power morcellation of uterine leiomyomas during laparoscopy, we sought to evaluate the use of preoperative two- (2D) and three- (3D) dimensional transvaginal ultrasound (US) assessment of uterine volume to predict the need for morcellation in women undergoing laparoscopic hysterectomy (LH). METHODS: This was a prospective observational study performed between October 2008 and November 2011 in a tertiary referral laparoscopic unit. All women scheduled to undergo LH were included and underwent detailed preoperative transvaginal US. Uterine volumes were calculated using 2D-US measurements (ellipsoid formula), and using Virtual Organ Computer-aided AnaLysis (VOCAL™) having acquired 3D-US volumes of the uterus. Age, parity, need to morcellate and final uterine dry weight at histology were recorded. The estimated uterine volumes were then incorporated into a previously published logistic regression model to predict the need to morcellate for both nulliparous and parous women. The probability threshold cut-off of 0.14 (95% sensitivity) was evaluated in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (LRs). The performance of the models incorporating 2D- and 3D-US calculations were compared with 2D- and 3D-US-generated volumes alone, using receiver-operating characteristics (ROC) curves. RESULTS: Of 76 women who underwent LH during the study period, 79% (n = 60) had complete background and 3D-US data. Their mean age was 43.7 years, 91.7% were parous and 35% underwent morcellation. The greatest uterine volume that did not require morcellation was 404 mL estimated using 3D-US, which corresponded to a uterine volume of 688.8 mL using 2D-US. The smallest uterine volume that required morcellation was 118.9 mL using 3D-US, which corresponded to a uterine volume of 123.4 mL using 2D-US. The 3D-US uterine volume for parous women with a sensitivity of 95% based on ROC-curve analysis was approximately 120 mL, which equated to a predicted probability of morcellation cut-off of 0.14. For this cut-off, specificity was 55.00%, PPV was 51.35%, NPV was 95.65%, LR+ was 2.11 and LR- was 0.09. Areas under the ROC curves for the morcellation logistic regression model were 0.769 (95% CI, 0.653-0.886) and 0.586 (95% CI, 0.419-0.753) using uterine volumes obtained by 3D-US and by 2D-US, respectively, and they were 0.938 (95% CI, 0.879-0.996) and 0.815 (95% CI, 0.681-0.948) using 3D-US and 2D-US volumes alone. CONCLUSIONS: The need to morcellate can be predicted preoperatively using 3D-US uterine volumes obtained by transvaginal US with a fair degree of accuracy. Uteri with volumes smaller than 120 mL at 3D-US are very unlikely to require morcellation. The incorporation of 3D-US-estimated uterine volume into the previously published logistic regression model does not seem to confer any significant improvement when compared with 3D-US uterine volume alone to predict the need to morcellate in women undergoing total LH. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroids: an updated decision analysis following the 2014 Food and Drug Administration safety communications.

Previous decision analyses demonstrate the safety of minimally invasive hysterectomy for presumed benign fibroids, accounting for the risk of occult leiomyosarcoma and the differential mortality risk associated with laparotomy. Studies published since the 2014 Food and Drug Administration safety communications offer updated leiomyosarcoma incidence estimates. Incorporating these studies suggests that mortality rates are low following hysterectomy for presumed benign fibroids overall, and a minimally invasive approach remains a safe option. Risk associated with morcellation, however, increases in women age >50 years due to increased leiomyosarcoma rates, an important finding for patient-centered discussions of treatment options for fibroids.

[Assessment of the learning curves for intravesical adenoma morcellation using Piranha© device during endoscopic enucleation]. / Analyse de la courbe d'apprentissage de la morcellation intravésicale réalisée avec le système Piranha© au cours de l'énucléation endoscopique.

INTRODUCTION: Morcellation of intravesical adenoma (MIA) is an important part of the endoscopic enucleation procedure. The aim of this study was to analyse the learning curve of the MIA during endoscopic enucleation of the prostate. MATERIAL: We conducted a prospective study of the first 90 patients treated by endoscopic enucleation of the prostate by a single surgeon without previous experience of MIA. The population was divided into 3 consecutive groups of 30 patients. MIA was performed with the morcellator Pinranha (Wolf) and disposable blades (Vmax©). The criteria selected to assess the progress of MIA over time were: duration of MIA (min), the intraoperative complications encountered during MIA and weight morcelleted tissue. The efficacy of MIA was assessed with the ratio weight specimen/MIA duration (min/g) over time. RESULTS: The three groups were comparable in terms of age, ASA score of prostate volume. A significant decrease in the duration of MIA was found between groups 1 and 2 (12 versus 5.5min, P<0.0001), to reach a plateau in the group 3 (3min). A significant increase in the efficiency of MIA was found between group 1 and 2 (5.5 versus 11g/min, P<0.0001), to reach a plateau in the group 3 (20g/min). Bladder injuries were limited (7.7%), superficial and encountered in the early learning phase. CONCLUSION: In our experience, the MIA required a learning curve estimated between 30 and 60 procedures. LEVEL OF EVIDENCE: IV.

Current Issues with Hysterectomy.

Hysterectomy is one of the most common gynecologic surgeries. Early adoption of surgical advancements in hysterectomies has raised concerns over safety, quality, and costs. The risk of potential leiomyosarcoma in women undergoing minimally invasive hysterectomy led the US Food and Drug Administration to discourage the use of electronic power morcellator. Minimally invasive hysterectomies have increased substantially despite lack of data supporting its use over other forms of hysterectomy and increased costs. Health care reform is incentivizing providers to improve quality, improve safety, and decrease costs through standardized outcomes and process measures.

Updates in uterine fibroid tissue extraction.

PURPOSE OF REVIEW: Safety concerns regarding morcellation of presumed benign fibroid disease have led to an increase in recent research activity on this topic, as well as advances in surgical technique. RECENT FINDINGS: The prevalence of occult leiomyosarcoma is debated; however, estimates from a robust meta-analysis suggest it may be in the range of 1 case per 1960-8300 fibroid surgeries. Advancing age is an important clinical risk factor for occult malignancy. The impact of tumor morcellation may vary by mode of tissue removal, though tissue fragmentation is consistently associated with poorer outcomes. Decision and cost analyses continue to support laparoscopic hysterectomy as a low-morbidity and cost-effective approach. The increased scrutiny on fibroid procedures in the past few years may lead to changes in surgical approach; however, alternative tissue extraction options are evolving, including incorporation of contained morcellation. SUMMARY: Although the incidence of occult leiomyosarcoma is low, outcomes are poor and may be worsened by morcellation. By addressing risk factors for malignancy and incorporating evolving surgical techniques into practice, gynecologists can continue to offer patients a minimally invasive approach for fibroid management.

Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation.

BACKGROUND: In April 2014, the US Food and Drug Administration (FDA) published its first safety communication discouraging "the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids." Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leiomyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the United States. OBJECTIVE: We sought to report temporal trends in surgical approach to hysterectomy and postoperative complications before and after the April 17, 2014, FDA safety communication concerning the use of power morcellation during myomectomy or hysterectomy. STUDY DESIGN: A retrospective cohort study was performed with patients undergoing hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from Jan. 1, 2013, through Dec. 31, 2014. The rates of abdominal, laparoscopic, and vaginal hysterectomy, as well as the rates of major postoperative complications and 30-day hospital readmissions and reoperations, were compared before and after April 17, 2014, the date of the original FDA safety communication. Major postoperative complications included blood transfusions, vaginal cuff infection, vaginal cuff dehiscence, ureteral obstruction, vesicovaginal fistula, deep and organ space surgical site infection, acute renal failure, respiratory failure, sepsis, pulmonary embolism, deep vein thrombosis requiring therapy, cerebral vascular accident, cardiac arrest, and death. We calculated the median episode cost related to hysterectomy readmissions using Michigan Value Collaborative data. Analyses were performed using robust multivariable multinomial and logistic regression models. RESULTS: There were 18,299 hysterectomies available for analysis during the study period. In all, 2753 cases were excluded due to an indication for cancer, cervical dysplasia, or endometrial hyperplasia, and 174 cases were excluded due to missing covariate data. Compared to the 15 months preceding the FDA safety communication, in the 8 months afterward, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005) and both abdominal and vaginal hysterectomies increased (1.7%, P = .112 and 2.4%, P = .012, respectively). Major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2-2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4-4.2% (P = .025). The rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDA communication (P = .177 and P = .593, respectively). The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-10,389). CONCLUSION: Following the April 2014 FDA safety communication regarding power morcellation, utilization of minimally invasive hysterectomy decreased, and major surgical, nontransfusion complications and 30-day hospital readmissions increased.

Compliance and complications of culdotomy.

BACKGROUND: Culdotomy is a practically exclusive appanage of gynaecological surgeons. Today the transvaginal access to pelvis and abdominal cavity is also utilized for non-gynecological surgery. METHODS: The authors report the complications and compliance of 326 culdotomies performed in the Simple Maternity Unit of Asiago Hospital (Asiago, Vicenza, Italy). The casuistry includes 18 adnexetomies, 90 ovarian cysts and fibroids enucleations and/or resections, 23 paraovarian cysts removals, 59 myomectomies, 120 sterilizations, 11 salpingectomies, 1 adesiolysis, 2 ovarian biopsies and 1 abscess drainage. RESULTS: Couldtomy showed to be a procedure with good results in terms of 18 grade 1 and 1 grade IV (5.8%) of Clavien-Dindo grading system for classification of surgical complications, the incidence of conversions in laparotomies, laparoscopies and vaginal hysterectomy (3.1%), the average hospital postoperatory admission (25 hours), low cost of culdotomy compared to laparotomic and laparoscopic surgery; absence of dispareunia and/or other discomforts at long term. CONCLUSIONS: Culdotomy is a simple, proper and alternative route, especially when morcellation is unavoidable.

Cost-Effectiveness of Laparoscopic Hysterectomy With Morcellation Compared With Abdominal Hysterectomy for Presumed Myomas.

STUDY OBJECTIVE: Hysterectomy for presumed leiomyomata is 1 of the most common surgical procedures performed in nonpregnant women in the United States. Laparoscopic hysterectomy (LH) with morcellation is an appealing alternative to abdominal hysterectomy (AH) but may result in dissemination of malignant cells and worse outcomes in the setting of an occult leiomyosarcoma (LMS). We sought to evaluate the cost-effectiveness of LH versus AH. DESIGN: Decision-analytic model of 100 000 women in the United States assessing the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained (Canadian Task Force classification III). SETTING: U.S. hospitals. PATIENTS: Adult premenopausal women undergoing LH or AH for presumed benign leiomyomata. INTERVENTIONS: We developed a decision-analytic model from a provider perspective across 5 years, comparing the cost-effectiveness of LH to AH in terms of dollar (2014 US dollars) per QALY gained. The model included average total direct medical costs and utilities associated with the procedures, complications, and clinical outcomes. Baseline estimates and ranges for cost and probability data were drawn from the existing literature. MEASUREMENTS AND MAIN RESULTS: Estimated overall deaths were lower in LH versus AH (98 vs 103). Death due to LMS was more common in LH versus AH (86 vs 71). Base-case assumptions estimated that average per person costs were lower in LH versus AH, with a savings of $2193 ($24 181 vs $26 374). Over 5 years, women in the LH group experienced 4.99 QALY versus women in the AH group with 4.91 QALY (incremental gain of .085 QALYs). LH dominated AH in base-case estimates: LH was both less expensive and yielded greater QALY gains. The ICER was sensitive to operative costs for LH and AH. Varying operative costs of AH yielded an ICER of $87 651/QALY gained (minimum) to AH being dominated (maximum). Probabilistic sensitivity analyses, in which all input parameters and costs were varied simultaneously, demonstrated a relatively robust model. The AH approach was dominated 68.9% of the time; 17.4% of simulations fell above the willingness-to-pay threshold of $50 000/QALY gained. CONCLUSION: When considering total direct hospital costs, complications, and morbidity, LH was less costly and yielded more QALYs gained versus AH. Driven by the rarity of occult LMS and the reduced incidence of intra- and postoperative complications, LH with morcellation may be a more cost-effective and less invasive alternative to AH and should remain an option for women needing hysterectomy for leiomyomata.

[A critical assessment of morcellation in case of uterine malignancies and its impact on gynecologic surgery: From "precautionary principle" to "realism"]. / Impact pronostique de la morcellation chirurgicale en cas de cancers utérins: du « principe de précaution ¼ au « réalisme ¼.

Minimally invasive surgery has demonstrated benefits that include improved pain control, decreased infection risk, and faster surgical recovery and return to work. Morcellation is an integral part of making laparoscopic surgery possible for the removal of large uterine leiomyomata, and the development of power morcellation has increased efficiency during these procedures. Morcellation may expose patients to increased morbidity in certain circumstances. This is particularly true in cases of unrecognized malignancy, where intra-abdominal dissemination of cancer may worsen the prognosis (overall survival and disease free survival). A critical review of published data supports that tissue morcellation can be performed safely in screened and selected patients.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal).