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

Yale University

Status: Enrolling

Conditions: Appendicitis

Treatments: Other: Drainage or antibiotics; Procedure: Operative management

Study type: Interventional

Funder types: Other

Identifiers

NCT04168866

2000026799

No NIH funding (Other Identifier)

Details and patient eligibility

About

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.

Full description

Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Surgery

Experimental group

Description:

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.

Treatment:

Procedure: Operative management

Non-operative management

Active Comparator group

Description:

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.

Treatment:

Other: Drainage or antibiotics