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Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

NCT02991937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-01-21

Study results available
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Summary

Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.

Conditions

  • Appendicitis

Interventions

DRUG

Piperacillin/Tazobactam

24 hours of IV antibiotic administration

PROCEDURE

Surgical Treatment

Appendectomy

Sponsors & Collaborators

Principal Investigators

  • Jason Fisher, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02991937 on ClinicalTrials.gov