title: Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.
abstract: 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.
  
  
  CONCLUSIONS
  A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA; Department of Medicine, Division of Infectious Diseases, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA. Electronic address: dtalan@ucla.edu.
authors.forename: David A
authors.initials: DA
authors.lastname: Talan
authors.affiliation: Department of Surgery, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Darin J
authors.initials: DJ
authors.lastname: Saltzman
authors.affiliation: Department of Emergency Medicine, Ronald Reagan Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: William R
authors.initials: WR
authors.lastname: Mower
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Anusha
authors.initials: A
authors.lastname: Krishnadasan
authors.affiliation: Department of Radiology, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Cecilia M
authors.initials: CM
authors.lastname: Jude
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Ricky
authors.initials: R
authors.lastname: Amii
authors.affiliation: Division of Pediatric Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA; Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: DeUgarte
authors.affiliation: Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: James X
authors.initials: JX
authors.lastname: Wu
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Kavitha
authors.initials: K
authors.lastname: Pathmarajah
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Ashkan
authors.initials: A
authors.lastname: Morim
authors.affiliation: Department of Emergency Medicine, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA; Department of Medicine, Division of Infectious Diseases, Olive View-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Moran
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001062:Appendectomy / Q000706:statistics & numerical data; D001064:Appendicitis / Q000453:epidemiology / Q000628:therapy*; D000077525:Cefdinir; D002511:Cephalosporins / Q000008:administration & dosage*; D002648:Child; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D000077727:Ertapenem; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D010045:Outpatients; D010146:Pain / Q000453:epidemiology; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult; D047090:beta-Lactams / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D047090:beta-Lactams; D008795:Metronidazole; D000077525:Cefdinir; D000077727:Ertapenem