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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Description

Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.

Eligibility

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

Study details

Appendicitis

NCT04168866

Yale University

27 January 2024

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