A significant increase in major and minor complications following hysterectomy was noted in a large retrospective cohort study that was conducted after the US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellation during a hysterectomy in November 2014.
The warning was issued because of fear of dissemination of undiagnosed occult leiomyosarcoma in the benign fibroid mass.
Hysterectomy is one of the most common gynecological surgery carried out in the United States with more than 600,000 procedures per year. Following the warning, the use of power morcellator in minimally invasive gynecological surgery (MIS) plummeted from 13.7% in early 2013 to 2.8% in early 2015.
The researchers write, "The results of two surveys of gynecologists evaluating the influence of the FDA warning on management strategies in hysterectomy and myomectomy showed that a large proportion of respondents shifted from the use of minimally invasive surgery [MIS] to the use of a larger incision or open abdominal procedures, raising concerns about an increase of surgical complications."
"Furthermore, the FDA decision was criticized for overestimating the risk associated with using power morcellation compared with the risk associated with preventing its use in a large group of women who could receive benefits from morcellation."
When women waiting in the gynecologist office were offered a survey about the preferred route of surgery, most them chose MIS over open surgery despite being informed about 1 in 368 risks of a malignant tumor in the benign mass.
The researchers scanned the data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database for major and minor surgical complications following the primary surgery.
A look at data from 603 participating academic and nonacademic hospitals, showed that 75,487 women underwent hysterectomy for benign gynecologic indications out of which nearly one-third (25, 571) was for uterine fibroid.
The investigators compared the rate of major and minor complications during the first 30 days following before and after the FDA issued the warning.
The mean age of the women was 47.8 years, of whom 32, 186 (42.6%) had the surgery before and 43, 301 (57.4%) had it after the FDA-issued warning. Nearly 60% were non-Hispanic white women followed by African American women who comprised 15.1%.
The major and minor complications were comparable in both the groups, but in a subset of women who underwent hysterectomy for fibroid, the major complication increased by 23% after the FDA-issued warning (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications increased by 21% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01).
The rate of open abdominal hysterectomies also increased from 37.2% to 43.0%, and the rate of minimally invasive surgery decreased from 56.1% to 49.7% (P < .001).
"This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States," the researchers write.
The study has limitations in terms of its retrospective nature and non-availability of data about complications after 30 days.
There was also no statistics about the decrease in the prevalence of cases whose occult malignancy was dispersed following the use of morcellator.
The researchers, however, stressed the need for informed and shared decision making between patients, providers and governing bodies till additional larger studies are conducted or preoperative diagnostic techniques are refined.
The researchers concluded that “Further research is warranted focusing on the refinement of these alternative techniques of uterine morcellation and on the identification of women who would benefit from MIS.”
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