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

ConditionAppendicitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Operative management

    Procedure/Surgery

    Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

  • Drainage or antibiotics

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: SurgeryExperimental treatment 1 intervention
Group B: Non-operative managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of hospital days

This includes all hospital days during the initial stay and any readmission.

Time frame
Within 60 days of randomization.

Secondary outcomes

1

Need for additional intervention for appendicitis

Percutaneous drainage, unplanned operative intervention.

Time frame
Within one year of the index admission.
2

Intra-abdominal abscess

Time frame
More than 7 days after index admission but within 60 days of randomization.
3

Failed attempted procedure.

Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.

Time frame
Within 60 days of randomization.
4

Complications

Defined by National Surgical Quality Improvement Program criteria.

Time frame
Within 60 days of randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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