A Randomized Clinical Trial of Non-operative Management for Acute Uncomplicated Appendicitis

Acute appendicitis is the most common surgical emergency in children. The current standard of treatment of acute appendicitis is appendectomy. With early recognition, increasing diagnostic accuracy and surgical advances, morbidity rates have dramatically lowered. However, surgery remains associated with pain, discomfort, risk of complications, and decreased quality of life. Because of the high incidence in childhood, appendicitis remains a substantial health care and societal burden.

Recently the paradigm for treating acute appendicitis has been challenged, with several randomized control trials (RCT) in adults showing that appendicitis may be safely treated with antibiotics alone. The goal of this multicenter, non-blinded intention-to-treat RCT is to compare the safety of non-operative management of uncomplicated appendicitis in children aged 5 to 18 years compared with urgent appendectomy. Patients will be randomized to either initial treatment with intravenous and oral antibiotics or urgent appendectomy, and followed for up to 4 years. We plan to enroll 1,036 participants in 8 PECARN sites over 3 years. This project is currently funded by a NIDDK planning grant. A U01 application was submitted in February 2018. If awarded, funding may begin as early as Fall 2018.