Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Appendicitis

Treatments: Procedure: Surgical Treatment; Drug: Piperacillin/Tazobactam

Study type: Interventional

Funder types: Other

Identifiers

NCT02991937

16-00655

Details and patient eligibility

About

Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.

Enrollment: 39 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• first episode of appendicitis
• Pain < 48 hours
• White blood cell count < 18,000
• temperature < 103º F
• radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
• appendiceal diameter < 11 mm
• ability to take oral antibiotics

Exclusion criteria

• Prior antibiotic treatment for appendicitis
• presence of medical condition prohibiting surgical therapy
• radiographic or clinical evidence of abscess or perforation
• appendiceal mass, positive pregnancy test
• other diagnosis equally as likely as appendicitis
• pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
• inability to take oral antibiotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Medical Therapy

Active Comparator group

Description:

Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.

Treatment:

Drug: Piperacillin/Tazobactam

Surgical Intervention

Active Comparator group

Description:

Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.

Treatment:

Drug: Piperacillin/Tazobactam

Procedure: Surgical Treatment