Fast Track Appendectomy for Suppurative Appendicitis

Suppurative Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137603
• Other study ID #: 13-0660
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2023
• Source: Johns Hopkins All Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Infections
• Suppurative Appendicitis

Intervention

Other:
• Patients discharged home the same day following appendectomy
Patients are discharged to home on the same day following appendectomy with oral antibiotics.

Locations

Country	Name	City	State
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins All Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Length of Stay		Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Secondary	Thirty Day Complication Rate	Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation	Thirty days