Fast Track Appendectomy for Suppurative Appendicitis

NCT ID: NCT02137603

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Suppurative Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fast track

Patients discharged home the same day following appendectomy

Group Type: EXPERIMENTAL

Patients discharged home the same day following appendectomy

Intervention Type: OTHER

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

Admission

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patients discharged home the same day following appendectomy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole M Chandler, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

13-0660

Identifier Type: -

Identifier Source: org_study_id