Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

April 8, 2018 updated by: David A. Talan, Olive View-UCLA Education & Research Institute

A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis

The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

Study Overview

Detailed Description

This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

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

    • California
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult or child ages ≥5 years;
  • Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
  • Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
  • Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

  • instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antibiotics
Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
Active Comparator: Appendectomy
Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Complications
Time Frame: 30 days
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent appendicitis
Time Frame: 30 days
30 days
QOL outcomes
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 (Actual)

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 8, 2018

Last Verified

April 1, 2018

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 Uncomplicated Appendicitis

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