CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Antibiotics +2 moredrug
Likely dose
Zosyn (piperacillin-tazobactam); dose not specified. Alternative: ciprofloxacin and metronidazole for penicillin-allergic patientsAI-extracted
Key inclusion· 5
  • Peri-appendicular abscess on CT or MRI
  • Extruded appendicolith on CT or MRI
  • Visible hole in appendiceal wall on CT or MRI
  • Free peritoneal air on CT or MRI
Key exclusion· 10
  • Immunocompromised state
  • History of major abdominal operation
  • Previous appendicitis
  • Major comorbidities that preclude safe operation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03159754
NCT03159754Phase 4Completed

Optimal Care of Complicated Appendicitis

University of Michigan·interventional·Posted May 19, 2017·Updated Nov 28, 2023

In Brief

A Phase 4 clinical trial evaluating Early Appendectomy, Interval Appendectomy, and 1 other intervention for Appendicitis and 3 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 19, 2017
Enrollment StartJun 29, 2017
Primary CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Early Appendectomyprocedure

Removal of the appendix within 24 hours of admission

Interval Appendectomyprocedure

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

Antibioticsdrug

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