Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Peter Minneci

Status: Terminated

Conditions: Appendicitis

Treatments: Drug: Antibiotics only (Zosyn then Augmentin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02189668

IRB14-00218

Details and patient eligibility

About

To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Full description

This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Enrollment: 14 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age : 7-17 years

• Abdominal pain </= 48hours prior to receiving antibiotics

• White Blood Cell Count >5 but < 18

• US or CT confirmed early appendicitis plus:

  • US: </=1.1 cm in diameter, presence of appendicolith
  • CT: </= 1.1cm in diameter, presence of appendicolith

Exclusion criteria

• Positive urine pregnancy test
• Pain > 48 hours prior to first antibiotic dose
• Diffuse peritonitis
• History of chronic intermittent abdominal pain
• White Blood Cell count ≤ 5 or ≥ 18
• Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Non-operative Management

Experimental group

Description:

Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic

Treatment:

Drug: Antibiotics only (Zosyn then Augmentin)

Surgery

No Intervention group

Description:

Usual care with urgent appendectomy