Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

May 4, 2015 updated by: Francois Luks, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Other Names:
  • Augmentin®
  • Zosyn®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francois I. Luks, MD, PhD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Appendicitis

Clinical Trials on Piperacillin + Amoxicillin

3
Subscribe