Working… Menu

Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697059
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Francois Luks, Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Drug: Piperacillin + Amoxicillin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis
Study Start Date : September 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. Number of treatment failures [ Time Frame: Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment ]
    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 :
  1. Cost-saving of initial nonoperative treatment for early appendicitis [ Time Frame: 1 year ]

    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:
  1. Utility of initial nonoperative treatment of early appendicitis [ Time Frame: 1 year ]

    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01697059

Layout table for location information
United States, Rhode Island
Hasbro Children's Hospital (Rhode Island Hospital)
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Rhode Island Hospital
Layout table for investigator information
Principal Investigator: Francois I. Luks, MD, PhD Rhode Island Hospital

Layout table for additonal information
Responsible Party: Francois Luks, Francois I. Luks, MD, PhD, Rhode Island Hospital Identifier: NCT01697059     History of Changes
Other Study ID Numbers: RIH408212
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Francois Luks, Rhode Island Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Disease
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action