Non-operative Management of Early Appendicitis in Children

August 22, 2023 updated by: Peter Minneci
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.

The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).

Study Type

Observational

Enrollment (Actual)

102

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's 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

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children treated a tertiary care Children's Hospital

Description

Inclusion Criteria:

  • Age : 7-17 years
  • Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)
  • White blood cell count (WBC) < 15,000
  • C reactive protein (CRP) <4 (if obtained)
  • Focal abdominal pain </= 36 hours prior to receiving antibiotics

Exclusion Criteria:

  • English is not the primary language of either the child or parent/guardian
  • Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe developmental delay
  • Positive urine pregnancy test
  • Diffuse peritonitis
  • Fecalith
  • History of chronic intermittent abdominal pain
  • WBC >/= 15
  • CRP>/= 4 (if obtained)
  • Pain > 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

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

Cohorts and Interventions

Group / Cohort
Non-operative Group
Patients and caregivers who agree to receive non-operative management with antibiotics alone
Surgery Group
Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of Non-operative management
Time Frame: 1 year
The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Outcomes
Time Frame: 1 year
The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.
1 year

Collaborators and Investigators

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

Sponsor

Peter Minneci

Investigators

  • Principal Investigator: Peter C Minneci, MD, Nationwide Children's 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.

General Publications

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)

October 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Estimated)

August 22, 2023

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimated)

October 31, 2012

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-00406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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