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Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Information source: Rhode Island Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Appendicitis

Intervention: Piperacillin + Amoxicillin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Rhode Island Hospital

Official(s) and/or principal investigator(s):
Francois I. Luks, MD, PhD, Principal Investigator, Affiliation: Rhode Island Hospital


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.

Clinical Details

Official title: Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of treatment failures

Secondary outcome: Cost-saving of initial nonoperative treatment for early appendicitis


Minimum age: 5 Years. Maximum age: 18 Years. Gender(s): Both.


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

Locations and Contacts

Hasbro Children's Hospital (Rhode Island Hospital), Providence, Rhode Island 02905, United States
Additional Information

Related publications:

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.

Powers RJ, Andrassy RJ, Brennan LP, Weitzman JJ. Alternate approach to the management of acute perforating appendicitis in children. Surg Gynecol Obstet. 1981 Apr;152(4):473-5.

St Peter SD, Aguayo P, Fraser JD, Keckler SJ, Sharp SW, Leys CM, Murphy JP, Snyder CL, Sharp RJ, Andrews WS, Holcomb GW 3rd, Ostlie DJ. Initial laparoscopic appendectomy versus initial nonoperative management and interval appendectomy for perforated appendicitis with abscess: a prospective, randomized trial. J Pediatr Surg. 2010 Jan;45(1):236-40. doi: 10.1016/j.jpedsurg.2009.10.039.

Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granström L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7.

Yardeni D, Hirschl RB, Drongowski RA, Teitelbaum DH, Geiger JD, Coran AG. Delayed versus immediate surgery in acute appendicitis: do we need to operate during the night? J Pediatr Surg. 2004 Mar;39(3):464-9; discussion 464-9.

Starting date: September 2012
Last updated: May 4, 2015

Page last updated: August 23, 2015

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