The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Marshall University

Status: Enrolling

Conditions: Perforated Appendicitis

Treatments: Procedure: Appendectomy; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT04253899

1504002-3

Details and patient eligibility

About

Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.

A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women of all ages.
• Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
• Formal consent for the present study must be signed by the patient or his/her parents
• Patients with initial presentation of a phlegmon (abscess in evolution)

Exclusion criteria

• Patients with non-perforated appendicitis
• Presentation with initially non-perforated appendicitis but found perforation at surgery
• Patient with septic shock
• Patients who had previous appendectomy
• Current treatment of malignancy
• Immunocompromised patients
• Positive pregnancy test
• No consent for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Standard pediatric group:

Active Comparator group

Description:

patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)

Treatment:

Procedure: Appendectomy

Experimental pediatric group:

Experimental group

Description:

patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)

Treatment:

Other: Observation

Standard adult group:

Active Comparator group

Description:

patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)

Treatment:

Procedure: Appendectomy

Experimental adult group:

Experimental group

Description:

Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

Treatment:

Other: Observation