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.

ACOG Committee Opinion No. 770: Uterine Morcellation for Presumed Leiomyomas.

Morcellation is a surgical technique used to reduce the size of the uterus or myomas by creating smaller pieces to allow the tissue to be removed through small incisions or with laparoscopic instruments. Open (uncontained) morcellation of the uterus and myomas has been scrutinized because of the possible spread of an unsuspected leiomyosarcoma while using a power morcellator during a hysterectomy or myomectomy for presumed symptomatic uterine leiomyomas. Before considering open morcellation of the uterus, a woman should be evaluated to determine if she is at increased risk of malignancy of the uterine corpus. Morcellation of a malignancy is contraindicated, and women should be evaluated preoperatively to identify malignancy. However, leiomyosarcoma cannot be reliably diagnosed preoperatively; thus, there is a risk that a woman with a presumed leiomyoma may have a malignancy that may be spread through morcellation, leading to a potentially worsened prognosis. Although an abdominal hysterectomy or myomectomy may reduce the chance of spreading cancer cells in women with undiagnosed leiomyosarcoma, it is associated with increased morbidity when compared with minimally invasive approaches. The obstetrician-gynecologist and patient should engage in shared decision making, including informed consent explaining the risks and benefits of each approach to surgery for presumed leiomyomas, the risks and benefits of morcellation, and alternatives to morcellation.

Can the risks associated with uterine sarcoma morcellation really be prevented? Overview of the role of uterine morcellation in 2018.

OBJECTIVES: The objective of this literature review is to reiterate the epidemiology, clinical signs, and radiological signs that should be consistent with a uterine sarcoma as well as the precautionary pre- and postoperative principles that help prevent morcellation of uterine sarcomas when treating patients with uterine fibroids. METHOD: We conducted this literature review by consulting the Pubmed, Medline, and Cochrane Systematic Review databases up to 28/02/2017 using the following keywords: fibroid, myoma, leiomyoma, sarcoma, leiosarcoma, uterine cancer, myomectomy, hysterectomy, morcellation, and uterine morcellation. We also used the reference lists of the selected articles to find more data on the websites of North-American and European learned societies that specialise in obstetrics and gynaecology. RESULTS: In the case of morcellation of uterine fibroids, the risk of an undiagnosed uterine sarcoma is estimated to be between 1 in 278 to 1 in 1960 women. Preoperative examination, free informed consent following discussion about the risks and complications associated with morcellation, as well as research on the contraindications to the use of morcellation are the crucial points addressed by learned societies. The main solution recommended at present is morcellation confined to a laparoscopic bag. CONCLUSION: There is a risk of morcellating an occult sarcoma when performing a myomectomyor hysterectomy for fibroids. Implementing the use of morcellation containment bags should be the norm. The use of minimally invasive surgery (laparoscopic orvaginal) and the associated benefit-risk ratio compared to a laparotomy should also be discussed with the patient before the operation.

Novel Technique for Contained Power Morcellation through Umbilicus with Insufflated Bag.

In April 2014, the US Food and Drug Administration published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure and therefore advising against the use of power morcellation. These statements have encouraged the scientific community to look for new techniques that allows performing this procedure in a safer way, decreasing the risk of malignant dissemination thorough the abdominal cavity. We describe a new technique for power morcellation using a plastic bag through umbilicus using a latex glove and skin retractor as a single port device. This new procedure was performed in 4 women diagnosed with myomatous uterus. Median age was 40.5 years. No intraoperative complications, conversion to laparotomy or bag rupture occurred. Median surgical time was 195 min and median morcellation time was 48 min. Median in-hospital stay was 4.5 days. This new technique could be an acceptable and feasible alternative for specimen delivery during laparoscopic hysterectomy and myomectomy. However, it is still necessary to increase the number of procedures to assess its safety in case of uterine sarcoma. The video and supplemental contents demonstrate the safety and feasibility of the technique.

[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).