UW researchers will begin recruiting patients in May for a nearly $13 million, five-year study to determine whether antibiotics alone are better than surgery to treat uncomplicated appendicitis, which sends 300,000 Americans rushing to emergency surgery each year.
Nick Fedewa endured three days of stomach pain last October before he realized he had appendicitis.
“It was enough that you just wanted to curl up into a ball,” he recalled.
By the time the 27-year-old Seattle medical-data worker had a friend take him to the emergency room, he’d mentally prepared himself for surgery.
But in the ER at the University of Washington Medical Center, he encountered Dr. David R. Flum, who is an occasional co-worker — and among the best surgeons in the U.S. to explain why an operation wasn’t Fedewa’s only option.
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Flum, UW Medicine’s new associate chief medical officer, is the principal investigator for a nearly $13 million, five-year study to determine whether offering antibiotics first may, in many cases, replace surgery as the best way to treat acute appendicitis.
Starting in May, Flum and colleagues will begin recruiting more than 1,500 appendicitis patients at UWMC and 10 other hospitals in Washington and California who agree to have their care essentially determined by the flip of a coin. An additional 500 patients who want to choose their treatment will be studied as well.
Patients with uncomplicated appendicitis who meet other criteria will be informed about the evidence for both approaches and asked to allow their care to be randomized to either drugs first or surgery. Doctors will present the information in a video on an iPad so that patients aren’t unduly swayed, and then answer any questions.
Contrary to common belief, there’s typically time for such a discussion, even in cases of acute appendicitis, Flum said.
“There’s this notion that appendicitis is a ticking time bomb and that if you don’t treat it, it will burst,” Flum explained. “That’s not true.”
The study is the first head-to-head trial in the U.S. to compare an alternative to appendectomy, the most common emergency surgery in the country.
“It’s a real game-changer to give people options,” said Dr. Giana H. Davidson, a UW general surgeon working with Flum on the project, which is funded by the Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit authorized by Congress. .
Breaking with tradition
For more than 130 years, removing the appendix has been the standard for the condition that sends more than 300,000 patients rushing for emergency surgery each year.
Appendicitis typically occurs when a blockage causes the wormlike pouch connected to the large intestine to become infected and swell, sometimes leading to rupture — and death.
But results from a half-dozen clinical trials in the past two decades in Europe have shown that using antibiotics first is likely safe and successful. In the studies of more than 1,700 patients, about three of four adults who received the drugs recovered without surgery. Inflammation was halted and their appendixes returned to normal. Even those who required operations later weren’t harmed by waiting.
Those results prompted some U.S. surgeons to follow suit, motivated in large part by the notion that it’s best to avoid surgery if possible, Flum said.
“They’ve been variably offering it because they have a hunch about it,” he said.
For the past year, Flum and colleagues at UWMC have been informally offering the option of antibiotics first to patients with uncomplicated appendicitis. In Fedewa’s case, he received antibiotics intravenously and remained in the hospital for less than a day, then took pills for the next week.
Still, doctors who regularly perform appendectomies continue to debate the merits of using drugs instead of performing a quick, common surgery that solves the problem permanently.
Dr. Philip S. Barie, a professor of surgery at Weill Cornell Medical College in New York, has been an outspoken critic of offering antibiotics first without better evidence. He contends that if one in four patients later requires surgery, the failure rate is too high and patients should be informed that the practice is still experimental.
“I think the whole thing has gotten very much ahead of itself,” he said. “Some people are getting rather evangelistic about this.”
A review led by UW researchers and published in the Journal of the American College of Surgeons this year found that, despite the European trials, it’s still too early to change the U.S. standard to a drugs-first approach.
“There are many unanswered questions about outcomes of antibiotics-first treatment that patients have told us are important to them,” noted Dr. Anne P. Ehlers, a UW research fellow in the department of surgery.
A mixed result
That’s where the new trial comes in. It will focus on the way the decisions affect overall patient experience, said Dr. Joe Selby, executive director of the patient-centered outcomes institute, which funds pragmatic research aimed at changing practice.
“This is a large study and a broad study in an American setting that measures important things like how did you feel? How quickly were you able to return to work again?” he noted. “How about all of those other outcomes? It’s not just whether the antibiotics helped you avoid surgery.”
One patient might want to avoid surgery at all costs, while another patient might worry too much that the appendicitis will reoccur, and the anxiety would outweigh any benefit, Flum said.
The trial will run through December 2020, with results expected in early 2021.
For Nick Fedewa, the choice to try drugs first seemed like an easy fix. But six weeks after the antibiotic treatment, the pain in his gut returned. He was back in the ER in December; surgery followed quickly.
“No one quite believes you when you say you’ve had appendicitis twice,” he said. “I just consider myself unfortunate.”
Despite his experience, Fedewa said he was glad to have been offered the option.
Flum hopes others will feel the same.
“Just because we’ve treated this with surgery for 130 years doesn’t mean we have to continue doing that,” he said.