Impact of randomized trial on use of minimally invasive surgery for cervical cancer
In a Correspondence article published in the April 29, 2021 issue of the New England Journal of Medicine, researchers from University Hospitals (UH) Cleveland Medical Center, and New York Presbyterian Hospital—Weill Cornell Medicine in New York, found a substantial reduction in the use of minimally invasive surgery for cervical cancer after publication of the results a major study called the Laparoscopic Approach to Cervical Cancer (LACC) in November 2018.
The earlier study, which compared minimally invasive surgery with open abdominal radical hysterectomy in patients with early-stage cervical cancer, found that minimally invasive surgery was associated with worse disease-free and overall survival than open surgery. As a result of that study and other related studies, many guidelines recommended that surgeons use open surgery rather than minimally invasive surgery.
In the new article, the researchers sought to answer the extent to how practice changed.
They assessed the use of minimally invasive surgery as compared with open radical hysterectomy for cervical cancer before and after publication of the LACC Trial.
They studied the records of 2,437 patients who received care at 283 medical centers between November 2015 and March 2020. About 61 percent of these patients were treated at academic centers and about 39 percent at nonacademic centers.
The percentage of hysterectomies performed with a minimally invasive approach was calculated each month, and the percentages before and after publication of the LACC Trial results were compared. A 3-month period to allow for the dissemination of the LACC Trial results was excluded from this comparison.
David Sheyn, MD, one of the authors and a gynecologist at UH Cleveland Medical Center and the UH Urology Institute, said the use of minimally invasive surgery decreased dramatically after publication of the LACC Trial.
"After adjustment, the odds of minimally invasive surgery were 59 percent lower following publication of the trial results; this demonstrates a remarkably fast response to solid clinical data," said Dr. Sheyn.
Before the trial results were published, the minimally invasive approach was used in 58 percent of hysterectomies, as compared with 42.9 percent after publication.
Jonathan Shoag, MD, the senior author of the study and a urologic oncologist from the UH Urology Institute, said that the odds were still higher for minimally invasive surgery at a non-academic medical center compared with an academic medical center; 0.81 versus 0.27. He said the results of the new study suggests an opportunity to improve outcomes at non-academic medical centers.
Spyridon Basourakos, MD, urology resident from New York Presbyterian Hospital—Weill Cornell Medicine in New York, stated that understanding the impact of clinical trials on real-world practice patterns may help to bridge the gap between new discoveries and population-level clinical outcomes.