Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

NCT01697059 | Completed

• 1 other identifier: RIH408212
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Keywords

appendicitis

Outcome Measures

Primary Outcomes (1)

• Number of treatment failures

  If after a period of at least 8 hours (and 2 doses of intravenous antibiotics), the patient's symptoms worsen, or fail to subside within 18 hours, the patient will undergo an emergent/urgent appendectomy, and treatment will proceed as per standard-of-care (1 intraoperative dose of antibiotics, with or without postoperative antibiotics, progressive postoperative diet and discharge home once tolerating a regular diet). The patient will then be considered having failed nonoperative treatment.

  Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment

Secondary Outcomes (1)

• Cost-saving of initial nonoperative treatment for early appendicitis

  1 year

Other Outcomes (1)

• Utility of initial nonoperative treatment of early appendicitis

  1 year

Study Arms (1)

Piperacillin + Amoxicillin

EXPERIMENTAL

Piperacillin/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.

Drug: Piperacillin + Amoxicillin

Interventions

Piperacillin + Amoxicillin DRUG

Also known as: Zosyn®, Augmentin®

Piperacillin + Amoxicillin

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Maximum 48-hour-history of abdominal pain
• Diagnosis of acute appendicitis based on clinical, laboratory and/or radiologic criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Hasbro Children's Hospital (Rhode Island Hospital)

Providence, Rhode Island, 02905, United States

Location

Related Publications (5)

• 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.

  PMID: 20627213 BACKGROUND

• 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.

  PMID: 7209777 BACKGROUND

• 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.

  PMID: 20105610 BACKGROUND

• Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.

  PMID: 16736333 BACKGROUND

• 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. doi: 10.1016/j.jpedsurg.2003.11.020.

  PMID: 15017571 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Piperacillin; Amoxicillin; Piperacillin, Tazobactam Drug Combination; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Sulfones; Drug Combinations; Pharmaceutical Preparations; Clavulanic Acid; Clavulanic Acids

Study Officials

• Francois I. Luks, MD, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Francois I. Luks, MD, PhD

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

US (1)