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Non-operative Management of Pediatric Appendicitis With an Appendicoltih

P

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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