Recruiting

Operative vs. Non-Operative

Sponsor:

Yale University

Code:

NCT04168866

Conditions

Appendicitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Operative management

Drainage or antibiotics

Study Details

Brief 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.

Conditions

Appendicitis

Study ID

NCT04168866

Start date

Mar 11, 2020

Status verified date

Aug, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Operative management

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

Drainage 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kevin Schuster, MD, MPH

203 785 2572kevin.schuster@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06512

Contacts

Kevin Schuster, MD

+1 (203) 785-2572kevin.schuster@yale.edu

More Information

Sponsor

Yale University

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-08-29.