Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Francois Luks, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01697059
First received: September 24, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Acute Appendicitis
Drug: Piperacillin + Amoxicillin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Number of treatment failures [ Time Frame: Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Cost-saving of initial nonoperative treatment for early appendicitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Cost of nonoperative treatment will be calculated as follows: Hospitalization charges (# hospital days - observation) + costs of antibiotics (actual number of doses/days) + outpatient surgery hospital fee (operating room and PACU time) + additional costs associated with unanticipated events (e.g., Emergency room visits after initial discharge).

    Control costs (contemporary data) will consider the following: Hospitalization charges (# hospital days) + intravenous antibiotics (price/dose x number of doses).



Other Outcome Measures:
  • Utility of initial nonoperative treatment of early appendicitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Questionnaires given to parents and patients regarding their experience of initial nonoperative treatment and interval appendectomy will be analyzed, and compared with controls and with standard levels in the literature.

    The Pediatric Quality of Life Scale-Version 4.0 (PedsQL) is a reliable and valid 23-item questionnaire that measures child health-related quality of life (QOL) in the preceding month. Items can be recoded from 100 to 0 on 25-point intervals and averaged to produce a total score (α=0.90). The total score is derived from items that assess the child's physical (e.g., problems with low energy or difficulty lifting something heavy), emotional (e.g., feeling afraid, angry, or scared), social (e.g., problems with getting teased or other children not wanting to be friends), and school functioning (e.g., problems paying attention in class or missing school). Higher scores indicate better QOL.



Estimated Enrollment: 65
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Piperacillin + Amoxicillin
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
Other Names:
  • Zosyn®
  • Augmentin®

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697059

Locations
United States, Rhode Island
Hasbro Children's Hospital (Rhode Island Hospital) Recruiting
Providence, Rhode Island, United States, 02905
Contact: Francois I Luks, MD, PhD    401-228-0556    Francois_Luks@brown.edu   
Contact: Debra Watson-Smith, RN    401-228-0559    dwsmith@usasurg.org   
Principal Investigator: Francois I Luks, MD, PhD         
Sub-Investigator: Christopher S Muratore, MD         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Francois I. Luks, MD, PhD Rhode Island Hospital
  More Information

Publications:
Responsible Party: Francois Luks, Francois I. Luks, MD, PhD, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01697059     History of Changes
Other Study ID Numbers: RIH408212
Study First Received: September 24, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
appendicitis

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Amoxicillin
Piperacillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014