Non-operative Management of Early Appendicitis in Children

Appendicitis Clinical Trial

Official title:

Non-operative Management of Early Appendicitis in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01718275
• Other study ID #: IRB12-00406
• Status: Active, not recruiting
• Start date: October 2012
• Est. completion date: August 22, 2023

Study information

• Verified date: August 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

Description:

Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.

The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: August 22, 2023
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age : 7-17 years

• Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)

• White blood cell count (WBC) < 15,000

• C reactive protein (CRP) <4 (if obtained)

• Focal abdominal pain </= 36 hours prior to receiving antibiotics

Exclusion Criteria:

• English is not the primary language of either the child or parent/guardian

• Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI = 95th percentile for age and sex), severe developmental delay

• Positive urine pregnancy test

• Diffuse peritonitis

• Fecalith

• History of chronic intermittent abdominal pain

• WBC >/= 15

• CRP>/= 4 (if obtained)

• Pain > 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Related Conditions & MeSH terms

• Appendicitis

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)

Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. — 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of Non-operative management	The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.	1 year
Secondary	Adverse Outcomes	The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.	1 year