Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Appendicitis Clinical Trial

Official title:

Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02189668
• Other study ID #: IRB14-00218
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Antibiotics only (Zosyn then Augmentin)
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Peter Minneci

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1 — View Citation

Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Did Not Have an Appendectomy	Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge	1 year
Secondary	Number of Participants With Complicated Appendicitis	Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.	1 year