This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
The appendix is a small sac at the bottom of the large intestine. Appendicitis is a health problem that occurs when this sac becomes inflamed. Appendicitis can cause pain, fever, and even death.
Each year in the United States, more than 70,000 children have surgery to treat this health problem. However, studies outside the United States show that with most patients, antibiotics alone are safe and work well to treat appendicitis. People treated with antibiotics may also be able to return to normal activities faster than those who have surgery. Some patients may prefer treatment with antibiotics alone.
In this study, the research team wants to know how well antibiotics alone, compared with surgery, work to treat children with appendicitis.
Who can this research help?
Findings from this study may help doctors, patients, and caregivers decide whether to treat appendicitis with surgery or antibiotics alone.
What is the research team doing?
The research team is enrolling 1,040 patients ages 7 to 17 with early appendicitis from 10 children’s hospitals. Patients and their families choose between antibiotics alone or surgery to remove the appendix. Patients who choose antibiotics alone receive at least 24 hours of intravenous, or IV, antibiotics at the hospital. If their condition improves, they switch to oral antibiotics, taken at home for six more days. Patients who choose surgery get IV antibiotics and surgery to remove the appendix.
The research team is surveying families and looking at medical records at discharge, 30 days, 6 months, and 1 year after treatment to find out how many patients who got antibiotics alone later had surgery. The survey also asks patients and caregivers about how fast they returned to daily activities and how happy they were with care. The team also asks patients about their quality of life and treatment complications.
Patients, caregivers, doctors, health insurers, and health educators helped design and conduct the study.
Research methods at a glance
|Design||Observational: case-control study|
|Population||English and non-English speaking patients ages 7 to 17 with early appendicitis showing hyperemia, white blood cell count >5,000/µL and ≤18,000/µL, and abdominal pain ≤48 hours prior to receiving antibiotics|
Primary: success rate, or percentage of patients choosing non-operative management who have not undergone an appendectomy; disability days, or number of days without normal schedule
Secondary: percentage of patients with perforated appendicitis at operation, caregiver disability, quality of life, satisfaction with care, complications of appendicitis, treatment complications
|1-year follow-up for primary outcomes|
|Results Highlights: More than 70,000 children in the United States have surgery each year to treat appendicitis. As reported in JAMA, a PCORI-funded study found that among children with uncomplicated appendicitis, nonsurgical treatment with antibiotics was successful in more than half of those patients, and compared with surgery initiated shortly after hospital admission, was associated with significantly fewer disability days. However, the results after one year did not meet the threshold success rate specified at the outset of the study.|