Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management

• Published in: Annals of emergency medicine Vol. 70; no. 1; pp. 1 - 11.e9
• Main Authors: Talan, David A., MD, Saltzman, Darin J., MD, PhD, Mower, William R., MD, PhD, Krishnadasan, Anusha, PhD, Jude, Cecilia M., MD, Amii, Ricky, MD, DeUgarte, Daniel A., MD, MS, Wu, James X., MD, Pathmarajah, Kavitha, MPH, Morim, Ashkan, MPH, Moran, Gregory J., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2017
• Subjects: Administration, Intravenous; Adolescent; Adult; Aged; Anti-Bacterial Agents - administration & dosage; Appendectomy - statistics & numerical data; Appendicitis - epidemiology; Appendicitis - therapy; beta-Lactams - administration & dosage; Cephalosporins - administration & dosage; Child; Cost-Benefit Analysis; Drug Therapy, Combination; Emergency; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Metronidazole - administration & dosage; Middle Aged; Outpatients; Pain - epidemiology; Pilot Projects; Quality of Life; Severity of Illness Index; Treatment Outcome; United States - epidemiology; Young Adult
• ISSN: 0196-0644; 1097-6760
• DOI: 10.1016/j.annemergmed.2016.08.446

Study objective Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy. Methods Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate. Results Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/μL (range 6,200 to 23,100/μL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. Conclusion A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.