Fast Track Appendectomy for Suppurative Appendicitis

June 28, 2023 updated by: Johns Hopkins All Children's Hospital

Fast Track Appendectomy in Pediatric Patients With Intraoperative Findings of Suppurative Appendicitis

The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patients aged 5-18
  • Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
  • Intraoperative findings of suppurative appendicitis

Exclusion Criteria:

  • Pregnancy
  • Complex medical history not appropriate for same day discharge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast track
Patients discharged home the same day following appendectomy
Other: Patients discharged home the same day following appendectomy
Patients are discharged to home on the same day following appendectomy with oral antibiotics.
No Intervention: Admission
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post Operative Length of Stay
Time Frame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thirty Day Complication Rate
Time Frame: Thirty days
Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation
Thirty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins All Children's Hospital

Investigators

  • Principal Investigator: Nicole M Chandler, MD, Johns Hopkins All Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimated)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suppurative Appendicitis

Clinical Trials on Patients discharged home the same day following appendectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe