Optimal Care of Complicated Appendicitis
Condition: Appendicitis; Perforated Appendicitis; Ruptured Appendicitis; Complicated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the
      infection and inflammation get worse, the appendix can die or burst, leading to a larger
      infection or even pus pockets around the appendix. This is called complicated, or perforated,
      appendicitis. Three common treatments for complicated appendicitis are

        -  appendectomy (removal of the appendix) right away

        -  appendectomy several weeks after the diagnosis

        -  treating the appendicitis without performing an appendectomy

      This study seeks to determine which of these three approaches is most cost-effective in
      children with complicated appendicitis.
    

Detailed description: 
      This is a single center, prospective study to compare early appendectomy vs. non-operative
      management of immunocompetent patients with complicated appendicitis, and then to compare
      interval appendectomy vs. no interval appendectomy in those managed with the initial
      non-operative approach. Patients who choose early appendectomy will have surgery within 24
      hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC
      count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and
      metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative
      management will receive piperacillin-tazobactam with or without abscess drainage until they
      are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days
      of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in
      clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo
      interval appendectomy at least 8 weeks from initial presentation. Those in the interval
      appendectomy group will follow-up one month post-operatively. Patients in both groups will be
      contacted 3 months and 2 years following initial presentation.

      {{{While 40 participants were enrolled as intended, and some data was collected from them, a
      combination of staff turnover and subsequent resource constraints did not permit the analysis
      originally intended. Thus, results data is shown comparing the early appendectomy
      participants against the other two arms combined.}}}}
    

Intervention name(s): Early Appendectomy; Interval Appendectomy; Antibiotics
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Removal of the appendix within 24 hours of admission; Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.; Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other intervention name(s): Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Ciprofloxacin; Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment