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Phase III

Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

  • Study HIC#:2000026799
  • Last Updated:07/15/2021

The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

  • Age18 years and older
  • GenderBoth
  • Start Date03/11/2020
  • End Date12/31/2025

Trial Purpose and Description

This is a prospective randomized controlled trial that will examine the best management for patients with appendicitis with abscess or phlegmon. Patients with appendicitis with abscess or phlegmon will be assigned to an operative or non-operative arm for management. The Primary objective is to determine if early operative management is superior to non-operative management in this population. The primary endpoint is total hospital days. 

Eligibility Criteria

Inclusion Criteria:

1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).

Exclusion Criteria:

  1. Antibiotic therapy greater than 24 hours prior to considering for enrollment.
  2. Attempted drainage before randomization
  3. Pregnancy
  4. Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
  5. Previous major intra-abdominal surgery by laparotomy
  6. Hospitalization within 2 weeks of randomization
  7. Presence of septic shock on admission.
  8. Mechanical ventilation
  9. Acute renal failure requiring dialysis

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