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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04168866
Status
Recruiting
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Conditions

  • Appendicitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Operative management — PROCEDURE
    Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
  • Drainage or antibiotics — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 11, 2020
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surgery
    Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.
  • Active Comparator: Non-operative management
    If a patient chooses non-operative management and 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.

Primary Outcome Measure

Number of hospital days [ Time Frame: Within 60 days of randomization. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06512
Kevin Schuster, MD
[email protected]
+1 (203) 785-2572

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By research site
Yale New Haven Hospital· New Haven, CT

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