Acute Appendicitis | Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis
Acute Appendicitis research study
What is the primary objective of this study?
Several recent studies have examined the feasibility and benefits of nonoperative treatment of perforated appendicitis in children. One such study showed a trend toward longer operative times for patients randomized to immediate appendectomy, but no overall advantage. In another larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other studies have demonstrated the safety of delaying appendectomy for perforated appendicitis. Emergency appendectomy is a well-established approach, and postoperative recovery in children is fast. Nevertheless, from the onset of symptoms through the hospital stay and the postoperative recovery, appendicitis causes a disruption of a family's normal routine (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation, patients have to wait until an operating room becomes available, or elective operations have to be placed on hold to accommodate the emergency operation. Each year, more than 250 children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery, or about one emergency add-on operation per working day. If an initial trial of antibiotics is safe for the treatment of appendicitis, converting an emergency operation into an elective, scheduled outpatient procedure may reduce stress and disruption of routine for patients and their families - and may allow better operating room planning for health care professionals and hospitals. The investigators hypothesize that initial antibiotic treatment of acute (non-perforated) appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of treating the disease and results in greater patient and family satisfaction. This pilot study aims to establish the safety and feasibility of treating acute appendicitis with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their families will be offered the possibility of initial nonoperative treatment and subsequent outpatient elective appendectomy in a nonrandomized, single arm study.
Who is eligible to participate?
Inclusion Criteria: - Maximum 48-hour-history of abdominal pain - Diagnosis of acute appendicitis based on clinical, laboratory and/or radiologic criteria Exclusion Criteria: - Duration of symptoms > 48 hours - Presence of an appendiceal abscess on imaging - Clinical or laboratory suspicion of advanced appendicitis, peritonitis or perforation - Significant comorbidities - Inability or unwillingness to complete a 1-week course of oral antibiotics - Allergy to penicillin
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Piperacillin + Amoxicillin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Piperacillin + AmoxicillinPiperacillin/Tazobactam (Zosyn®) 100 mg/kg, up to adult dose of 3 g, i.v. q 6 hours x 2 doses, followed by Ampicillin/Clavulanate (Augmentin®) 50 mg/kg/d p.o. in 3 divided doses for 1 week.
Start Date: September 2012
Completed Date: May 2015
Primary Outcome: Number of treatment failures
Secondary Outcome: Cost-saving of initial nonoperative treatment for early appendicitis
Study sponsors, principal investigator, and references
Principal Investigator: Francois I. Luks, MD, PhD
Lead Sponsor: Rhode Island Hospital
Narsule CK, Kahle EJ, Kim DS, Anderson AC, Luks FI. Effect of delay in presentation on rate of perforation in children with appendicitis. Am J Emerg Med. 2011 Oct;29(8):890-3. doi: 10.1016/j.ajem.2010.04.005. Epub 2010 Jul 13.