title: Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study.
abstract: BACKGROUND
  Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children. The aims of this study were to investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach.
  
  
  METHODS
  In a multicenter, prospective cohort study patients aged 7-17 years with a radiologically confirmed simple appendicitis were eligible. Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48-72 hours. Clinical reevaluation every 6 hours, daily blood samples, and ultrasound follow-up after 48 hours was performed. In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days. At any time, in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed. Follow-up continued until 8 weeks after discharge. Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis.
  
  
  RESULTS
  Of 44 eligible patients, 25 participated (inclusion rate, 57%; 95% CI, 42%-70%). Delayed appendectomy was performed in 2, and the other 23 were without symptoms at the 8 weeks follow-up. Minor complications occurred in three patients. None of the patients suffered from an adverse event or a recurrent appendicitis.
  
  
  CONCLUSIONS
  Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children; the intervention seems to be safe.
authors: Paediatric Surgical Centre of Amsterdam, Emma Children's Hospital AMC & VU University Medical Centre, Amsterdam, The Netherlands; Department of Surgery, Red Cross Hospital, Beverwijk, The Netherlands. Electronic address: rr.gorter@vumc.nl.
authors: Ramon R
authors: RR
authors: Gorter
authors: Paediatric Clinical Research Office Division Woman and Child, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Johanna H
authors: JH
authors: van der Lee
authors: Department of Surgery, Red Cross Hospital, Beverwijk, The Netherlands.
authors: Huibert A
authors: HA
authors: Cense
authors: Department of Paediatric Gastroenterology, VU University Medical Centre, Amsterdam, The Netherlands.
authors: C M Frank
authors: CM
authors: Kneepkens
authors: Department of Paediatric Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors: Marc H W A
authors: MH
authors: Wijnen
authors: Department of Surgery, Flevoziekenhuis, Almere, The Netherlands.
authors: Klaas H
authors: KH
authors: In 't Hof
authors: Child Health Evaluative Sciences (CHES), The Hospital for Sick Children, University of Toronto, Toronto, Canada.
authors: Martin
authors: M
authors: Offringa
authors: Paediatric Surgical Centre of Amsterdam, Emma Children's Hospital AMC & VU University Medical Centre, Amsterdam, The Netherlands.
authors: Hugo A
authors: HA
authors: Heij
mesh_terms: D000293:Adolescent; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D001062:Appendectomy; D001064:Appendicitis / Q000188:drug therapy* / Q000601:surgery; D002648:Child; D005260:Female; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D065093:beta-Lactamase Inhibitors / Q000627:therapeutic use*
chemical_list: D005839:Gentamicins; D065093:beta-Lactamase Inhibitors; D019980:Amoxicillin-Potassium Clavulanate Combination