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Non-operative treatment for Appendicitis (APPY Trial)

N/A

Waitlist Available

Led By Shawn D St. Peter, MD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year from randomization

Awards & highlights

APPY Trial Summary

This trial will test whether antibiotics are as effective as surgery for treating acute appendicitis in children.

APPY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

treatment failure

Secondary outcome measures

complications

number and duration of hospital admissions

time to discharge

+1 more

APPY Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-operative treatment groupExperimental Treatment1 Intervention

IV fluids, minimum 12 hrs IV antibiotics, minimum 12 hrs clear PO fluids only, regular clinical review. Discharge within 24 hrs after randomization, if study criteria met. If stable but not adequate improvement for discharge, non-operative management continues. If not improved by 48 hrs, appendectomy will be done. Discharge home once vital signs are within normal limits, light oral diet tolerated, adequate oral pain relief and mobile. Total 10 days of antibiotics (IV and oral) following randomization will be given. Antibiotics used vary between centers and will be current standard of care in that center; improving study feasibility and increased generalization of results.

Group II: Appendectomy groupActive Control1 Intervention

Laproscopic appendectomy within 18 hrs of randomization. IV antibiotics given from time of randomization and continued post-operatively per the standardized treatment regimen: children with visibly normal appendix or non-perforated acute appendicitis will receive no further antibiotics; children with perforated appendicitis will continue IV antibiotics for a minimum of 3 days and then per local practice. The type of antibiotics used in each center will be identical to those used in the non-operative treatment group.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

KK Women's and Children's HospitalOTHER_GOV

136 Previous Clinical Trials

46,611 Total Patients Enrolled

Karolinska University HospitalOTHER

477 Previous Clinical Trials

1,304,220 Total Patients Enrolled

1 Trials studying Appendicitis

51 Patients Enrolled for Appendicitis

Uppsala University Children's HospitalUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the population of this clinical trial include individuals under 50 years old?

"According to the inclusion criteria, young people aged 5-16 are eligible for this trial. Moreover, there are 18 studies specifically geared towards applicants under 18 and 11 more targeting those over 65 years old."

Answered by AI

Could I potentially qualify to be a part of this research endeavor?

"For this research project, 978 minors aged 5-16 with appendicitis must be recruited. Additional requirements for eligibility include written parental/legal guardian consent and child assent (or waiver). Appropriate medical imaging such as ultrasound or CT scan will also need to have been completed in order to verify the diagnosis of acute non-perforated appendicitis."

Answered by AI

Is admission to this research still available for prospective participants?

"As per clinicaltrials.gov, this particular trial is no longer actively recruiting participants. It was first posted on January 1st 2016 and its last update occurred on the 13th of January 2022; nonetheless, 32 other medical trials are presently enrolling patients."

Answered by AI

Recent research and studies

BMJ Paediatrics OpenJournal

Appendectomy Versus Non-operative Treatment for Acute Uncomplicated Appendicitis in Children: Study Protocol for a Multicentre, Open-label, Non-inferiority, Randomised Controlled Trial

Hall, Nigel J, Simon Eaton, Olivier Abbo, Alexis P Arnaud, Marianne Beaudin, Mary Brindle, Andreana Bütter, et al.. 2017. “Appendectomy Versus Non-operative Treatment for Acute Uncomplicated Appendicitis in Children: Study Protocol for a Multicentre, Open-label, Non-inferiority, Randomised Controlled Trial”. BMJ Paediatrics Open. BMJ. doi:10.1136/bmjpo-2017-000028.

clinicaltrials.govStudy

Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children

Shawn St. Peter 2016. "Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02687464.