by John W. Mitchell
, Senior Correspondent | December 30, 2015
A U.S. study to determine if a European protocol for treating acute, uncomplicated appendicitis with antibiotics — rather than surgery — is scheduled to commence in 2016.
The study has been preceded by a review of six European randomized controlled trials of antibiotic treatment.
The review, to be published next month in the Journal of the American College of Surgeons
, found that the European antibiotic treatment is successful in about three out of four patients. But the study found that it is too early to adopt the nonsurgical treatment in the U.S.
“We wanted to identify evidence gaps that were preventing clinicians from reaching definitive conclusions about the antibiotics-first approach,” Dr. Annie P. Ehlers, lead investigator and a research fellow in the department of surgery at the University of Washington (UW), Seattle, told HCB News. “We wanted to thoroughly review the previously performed studies so that we could design a study in the United States that would address unanswered questions.”
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According to UW sources, the U.S study will compare 1,552 patients who will be randomly treated for appendicitis with either antibiotics or the traditional surgical removal. A separate observational cohort of 500 patients who decline randomization will also be separately included in the study as well.
“Many questions are related to patient-centered outcomes such as quality of life among patients treated with antibiotics-first compared to surgery,” said Ehlers. “It was interesting that there was so little information about long-term pain, anxiety, or the amount of time missed from work due to their treatment or due to symptoms that occurred later on.”
She also noted that the one-year follow-up of the European antibiotic studies might not be long enough to consider all future complications, such as cancer. Surgeons and emergency medicine physicians in Washington and California are currently planning the study, which will be funded by The Patient-Centered Outcomes Research Institute. Results are not expected until 2020.
Appendicitis is a relatively common lifetime condition that strikes about seven percent of the population. Some 300,000 Americans undergo appendectomy each year. The role of the appendix, which is about the size of a pinkie finger, is unclear. According to UW sources, some researchers think it promotes good gut bacteria, while other believe the appendage to be a vestigial organ with no function. Surgical removal has been the standard of care for at least 120 years, according to the American College of Surgeons.
“It is unlikely that antibiotics-first will entirely replace surgery in the treatment of acute uncomplicated appendicitis,” explained Ehlers. “But we need to ensure that patients with acute, uncomplicated appendicitis have the most complete information possible when discussing their options with their physician.”