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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991937
• Other study ID #: 16-00655
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Piperacillin/Tazobactam
24 hours of IV antibiotic administration

Procedure:
• Surgical Treatment
Appendectomy

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent	Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL.	1 Year
Secondary	Readmission Rates	Percentage of patients readmitted to the hospital after discharge.	1 Year
Secondary	Incidence of Long-term Complications in Medical Therapy Group	Incidence of long-term complications will be reported as number of cases where appendicitis reoccurred resulting in appendectomies in participants of the medical therapy arm. This data will be obtained from medical record review.	1 Year