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NCT04168866NARecruiting

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

Yale University

Start Date

3/11/2020

Completion Date

12/31/2029

Summary

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Operative management

OTHER

Drainage or antibiotics

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Conditions

Appendicitis

Locations

Yale New Haven Hospital

New Haven, Connecticut 06512

United States