search
Back to results

Fast Track Appendectomy for Suppurative Appendicitis

Primary Purpose

Suppurative Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patients discharged home the same day following appendectomy
Sponsored by
Johns Hopkins All Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suppurative Appendicitis focused on measuring Suppurative appendicitis, appendicitis, pediatric

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins All Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fast track

Admission

Arm Description

Patients discharged home the same day following appendectomy

Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.

Outcomes

Primary Outcome Measures

Post Operative Length of Stay

Secondary Outcome Measures

Thirty Day Complication Rate
Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation

Full Information

First Posted
May 7, 2014
Last Updated
June 28, 2023
Sponsor
Johns Hopkins All Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02137603
Brief Title
Fast Track Appendectomy for Suppurative Appendicitis
Official Title
Fast Track Appendectomy in Pediatric Patients With Intraoperative Findings of Suppurative Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suppurative Appendicitis
Keywords
Suppurative appendicitis, appendicitis, pediatric

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fast track
Arm Type
Experimental
Arm Description
Patients discharged home the same day following appendectomy
Arm Title
Admission
Arm Type
No Intervention
Arm Description
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
Intervention Type
Other
Intervention Name(s)
Patients discharged home the same day following appendectomy
Intervention Description
Patients are discharged to home on the same day following appendectomy with oral antibiotics.
Primary Outcome Measure Information:
Title
Post Operative Length of Stay
Time Frame
Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Secondary Outcome Measure Information:
Title
Thirty Day Complication Rate
Description
Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation
Time Frame
Thirty days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole M Chandler, MD
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fast Track Appendectomy for Suppurative Appendicitis

We'll reach out to this number within 24 hrs