While antibiotic therapy has been proposed as an alternative to surgery for treating patients with appendicitis, findings from a nationwide clinical trial recently published in the New England Journal of Medicine found that patients who took antibiotics had similar outcomes as those who underwent surgery.
For the trial, a total of 1,552 patients presenting with appendicitis at 25 clinical sites across the U.S. were assigned either to a surgery group or antibiotics only group. Of the patients in the trial who were treated with antibiotics without immediate surgery, approximately three out of 10 subsequently underwent an appendectomy by 90 days.
The investigators found that the rate was higher — approximately 4 in 10 — for those with an appendicolith, a calcified deposit within the appendix, compared to 2.5 in 10 for those without an appendicolith.
Overall, complication rates for those in the antibiotics group was no higher than in the surgery group, except for the appendicolith group which had twice the risk of complications than those without. Additionally, both groups experienced symptoms from their appendicitis for about the same amount of time.
In terms of quality of life measures, the investigators found that the antibiotics group fared well, with nearly half avoiding hospitalization for initial treatment and missing less time from work or school. But, the same group reported more visits to the emergency room and days spent in the hospital overall, partly due to recurrent episodes. Both groups also spent the same amount of time in healthcare settings overall at initial treatment, with 70 percent of the antibiotics group avoiding surgery over the next 90 days.
“The trial is the largest of its kind and it’s patient-centric in the sense that it empowers patients to make meaningful decisions with data that included patients that look like them, as opposed to previous trials that had very narrow inclusion criteria and a lot of exclusions,” said Hasan Alam, MD, chair and the Loyal and Edith Davis Professor of Surgery, and a co-author of the study.
Notably, patients with more complex appendicitis, such as with microscopic perforation of the appendix or in the presence of an appendicolith, were included in the trial, which historically hasn’t been the case for previous clinical trials, according to Alam.
“The inclusion and exclusion criteria for this study were wide enough that we could actually rely on the data for real life decision making,” Alam said.
Appendicitis, the result of an inflamed and ruptured appendix, has traditionally required the surgical removal of the appendix through an appendectomy procedure. Currently, the procedure is done with a minimally invasive laparoscopic procedure, but patients who want to avoid an operation for any reason now have reliable data to help them make informed decisions, according to Alam.
These data are especially relevant during the current COVID-19 pandemic where patients may not want to stay in the hospital, or where the patients who have appendicitis may also have a concurrent coronavirus infection, Alam added. At the same time, hospital resources can also be limited during a pandemic.
“There has been a lot of concern based upon historical data that any delay in appendectomy could result in perforation of the appendix with catastrophic consequences. But this study clearly shows that these concerns are highly exaggerated, especially in the absence of an appendicolith,” Alam said.
Overall, the rate of those adverse events considered “serious” was similar between both patient groups: four percent of participants in the antibiotics group and three percent in the appendectomy group.
“The trial shows very convincingly that the rupture rate is about the same in both groups, so whether you treat them with antibiotics or take the appendix out, from a quality of life standpoint, antibiotics are no worse than appendectomy at the time of initial presentation. Thus, patient’s preference rather than fear should dictate the decision making,” Alam said.
As for next steps, Alam noted that the team plans to conduct one-year follow-ups on the patients, which will provide even more comprehensive data on long-term patient outcomes and the efficacy of each treatment option.
This work was supported by the Patient-Centered Outcomes Research Institute Award 1409-240099.