Appendicitis trial shows the risks and benefits of treating appendicitis with antibiotics instead of surgery

Antibiotics may be a good choice for some, but not all, patients with appendicitis, according to results from the Comparing Outcomes of antibiotic Drugs and Appendectomy (CODA) Trial reported today in the New England Journal of Medicine.

“We found that antibiotics were not worse than surgery when measuring overall health status, allowing most people to avoid an operation in the short term,” says Dionne Skeete, MD, clinical professor of surgery with University of Iowa Health Care, and CODA Trial site co-leader at University of Iowa Hospitals & Clinics, one of 25 hospitals where the CODA Trial was conducted. “There were advantages and disadvantages to both treatments, and patients are likely to prioritize these in different ways based on their characteristics, concerns, and perspectives,” she adds.

The UI’s participation in this study was a coordinated effort between its Departments of Surgery and Emergency Medicine. Brett Faine, PharmD, UI clinical assistant professor in the Department of Emergency Medicine and College of Pharmacy, was co-leader of the UI site with Skeete.

While nearly half of the antibiotics group avoided hospitalization for their initial treatment, overall, the time spent in the hospital was similar between groups.

“People treated with antibiotics more often returned to the emergency department, but missed less time from work and school,” said Bonnie Bizzell, Chair of the CODA Patient Advisory Board.  “Information like this can be important for individuals as they consider the best treatment option for their unique circumstance. The CODA Trial is really the first of its kind to capture these measures for appendicitis shared decision-making.”

Other initial findings of the CODA Trial include:

• Patients treated with either surgery (appendectomy) or antibiotics experienced symptoms of appendicitis for about the same amount of time.
• Approximately 3 out of 10 patients in the antibiotic group underwent appendectomy by 90 days.
• Patients with an appendicolith, a calcified deposit within the appendix, had twice the risk of complications than those without an appendicolith.
• Participants with an appendicolith had an increased chance of appendectomy by 90 days (4 in 10 with appendicolith vs 3 in 10 without).

The CODA Trial is the largest randomized clinical trial of appendicitis conducted to date. Across the United States, 1,552 participants were randomized to receive appendectomy or antibiotics-first for uncomplicated appendicitis. Funded by the Patient-Centered Outcomes Research Institute (PCORI) and led by Co-Principal Investigators Dr. David Flum (Professor and Associate Chair, Surgery, University of Washington) and Dr. David Talan (Professor, Emergency Medicine and Medicine/Infectious Diseases, David Geffen School of Medicine at UCLA), the CODA Trial was conducted among a collaborative network of 25 hospitals.

 “This study was important as it incorporated previous criticisms of studies looking at antibiotics as an alternative to appendectomy,” Skeete says. “Most importantly the study collected data from patients regarding health status and practical issues like time off work for patients and caregivers due to the disease. The study also had education and consent information for Spanish speakers who are often underrepresented in surgical research in the United States.”

Skeete added that the early results were published now because the journal felt the findings might provide helpful information for providers and patients managing this illness during a pandemic.

The CODA Collaborative, composed of clinicians at each of the 25 CODA Trial sites, patient advisors, and other stakeholders, will continue to share results from the trial as ongoing follow-up with participants is completed.