Non-operative Management of Early Appendicitis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2023-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

NCT01697059

Acute Appendicitis

COMPLETED NA

The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care

NCT06762275

Appendicitis Acute Acute Abdomen in Children

RECRUITING NA

Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences

NCT04454320

Intussusception

UNKNOWN

Recurrent Abdominal Pain in Children

NCT00526903

Abdominal Pain Irritable Bowel Syndrome

COMPLETED PHASE2

Reducing Pain and Anxiety Through Dietary Fiber Supplementation in Children With Abdominal Pain

NCT04619095

Functional Abdominal Pain Syndrome

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-operative Group

Patients and caregivers who agree to receive non-operative management with antibiotics alone

No interventions assigned to this group

Surgery Group

Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No