Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

University of Michigan

Status: Terminated

Conditions: Perforated Appendicitis

Treatments: Procedure: Interval appendectomy; Procedure: Initial appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00540189

HUM00007791

Details and patient eligibility

About

To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.

Enrollment: 23 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:children

• Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

• Age <2 and >18
• Pregnancy
• Immunocompromise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

23 participants in 2 patient groups

Initial appendectomy

Other group

Description:

children with complicated appendicitis will undergo initial appendectomy

Treatment:

Procedure: Initial appendectomy

Interval appendectomy

Other group

Description:

children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy

Treatment:

Procedure: Interval appendectomy