RecruitingNot ApplicableNCT04168866
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Sponsor
Yale University
Enrollment
180 participants
Start Date
Mar 11, 2020
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- \. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Exclusion Criteria9
- Antibiotic therapy greater than 24 hours prior to considering for enrollment.
- Attempted drainage before randomization
- Pregnancy
- Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
- Previous major intra-abdominal surgery by laparotomy
- Hospitalization within 2 weeks of randomization
- Presence of septic shock on admission.
- Mechanical ventilation
- Acute renal failure requiring dialysis
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Interventions
PROCEDUREOperative management
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
OTHERDrainage or antibiotics
If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04168866
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