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Optimal Care of Complicated Appendicitis

NCT03159754 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-28

Study results available
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Summary

When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are

* appendectomy (removal of the appendix) right away
* appendectomy several weeks after the diagnosis
* treating the appendicitis without performing an appendectomy

This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.

Conditions

  • Appendicitis
  • Perforated Appendicitis
  • Ruptured Appendicitis
  • Complicated Appendicitis

Interventions

PROCEDURE

Early Appendectomy

Removal of the appendix within 24 hours of admission

PROCEDURE

Interval Appendectomy

Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.

DRUG

Antibiotics

Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.

Sponsors & Collaborators

Principal Investigators

  • Steven W. Bruch, M.D. · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2020-03-26
Completion
2020-03-26
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 NCT03159754 on ClinicalTrials.gov