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)

Yale New Haven Hospital

New Haven, Connecticut, United States

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NCT04168866


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