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Early results from a PCORI-funded study show that seven in 10 adults with uncomplicated appendicitis were able to safely delay surgery for at least three months by taking a course of intravenous antibiotics, the researchers reported today in the New England Journal of Medicine (NEJM).
These initial findings from the Comparing Outcomes of Drugs and Appendectomy (CODA) Study—also presented for the first time today at the American College of Surgeons Clinical Congress 2020—were released early because they are of particular relevance to patients and providers alike during the coronavirus pandemic.
The trial’s full comparison of antibiotics and appendectomy, which will include one- and three-year follow-up on outcomes, is expected in a year.
“When COVID hit, there were recommendations … to restrict time in the operating room to minimize exposure to the virus and reserve personal protective equipment for healthcare providers,” Giana H. Davidson, MD, MPH, FACS, a study investigator and an associate professor of surgery at the University of Washington School of Medicine, said in a press release from the American College of Surgeons. “We were getting calls from all over the country asking for our CODA data.”
The research team, led by David Flum, MD, MPH, at the University of Washington School of Medicine, is comparing the outcomes of more than 1,500 patients at 25 hospitals across the country, making it the largest-ever clinical randomized trial of appendicitis treatment.
As the NEJM paper notes, rate of complications in the antibiotics group was twice as high as the rate in the appendectomy group, the number of emergency department visits was nearly three times as high, and more time was spent in the hospital. But the group taking antibiotics averaged fewer days missed from work, as did their caregivers.
The study is measuring clinical outcomes—broadly agreed, measurable changes in health or quality of life—as well as patient-reported outcomes that matter most to patients, such as time away from work or spent in the hospital. The results will provide helpful context to treatment options that patients explore in shared decision making with their physicians.
Antibiotic treatment will be good for many people but not for all. There were advantages and disadvantages to each treatment, and patients will value these differently based on their unique characteristics, concerns, and perspectives.David Flum, MD, MPH Principal Investigator, The CODA Study
“Antibiotic treatment will be good for many people but not for all,” Flum said. “There were advantages and disadvantages to each treatment, and patients will value these differently based on their unique characteristics, concerns, and perspectives.”
Nearly 300,000 Americans each year make an important healthcare decision about uncomplicated appendicitis. Appendectomy has been the standard treatment of appendicitis for more than a century and is the most common emergency abdominal procedure performed in the United States.
The CODA study is the latest example of PCORI-funded researchers answering timely questions that help patients and those who care for them make better-informed healthcare decisions—this time providing additional helpful context during a national pandemic. To receive ongoing updates on the study, visit the project page and click the Sign Up for Updates to This Study box at the top of the page.