Laparoscopic Hysterectomy Route, Resource Use, and Outcomes: Change After Power Morcellation Warning

Abstract

Objective: To examine changes in utilization of different types of laparoscopic hysterectomy, as well as their associated resource use and surgical outcomes, after the U.S. Food and Drug Administration (FDA) safety statement in April 2014 regarding power morcellation.

Methods: We retrospectively analyzed data from the 2012-2016 American College of Surgeons National Surgical Quality Improvement Program and identified 145,746 women undergoing hysterectomy for benign indications. We measured use of laparoscopic supracervical hysterectomy compared to total laparoscopic hysterectomy (including laparoscopic-assisted vaginal hysterectomy) in these patients, as well as operative time, surgical setting (inpatient vs outpatient), length of stay, and 30-day surgical outcomes (wound complication, medical complication, reoperation, and readmission). We used an interrupted time series analysis to examine the association between FDA warning and changes in utilization and outcomes of laparoscopic hysterectomy.

Results: After adjusting for patient characteristics and background trends in practice, use of laparoscopic supracervical hysterectomy was significantly lower in the postwarning than prewarning period (odds ratio [OR]=0.49, 95% CI 0.45-0.53), whereas use of total laparoscopic hysterectomy was not affected (OR 1.01, 95% CI 0.96-1.06). Overall, after an initial reduction, use of laparoscopic hysterectomy (laparoscopic supracervical hysterectomy and total laparoscopic hysterectomy combined) increased over time in the postwarning period (adjusted OR of utilization for each calendar quarter elapsed=1.03, 95% CI 1.02-1.03). After the FDA warning, operative time for laparoscopic supracervical hysterectomy increased by 11.45 minutes (95% CI 6.22-16.69), whereas the decreasing trend in the likelihood of inpatient stay for total laparoscopic hysterectomy was attenuated (OR for each calendar quarter elapsed=0.92 in prewarning period, 95% CI 0.91-0.93; and 0.97 in postwarning period, 95% CI 0.97-0.98). There was no significant change in 30-day surgical outcomes after the FDA warning.

Conclusion: Rates of laparoscopic supracervical hysterectomy fell in association with power morcellation safety warnings, whereas rates of other laparoscopic hysterectomies continued to rise. There was no change in patient outcomes among laparoscopic hysterectomies.