Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Acute Uncomplicated Appendicitis Clinical Trial

Official title:

A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447224
• Other study ID #: 1R21DK102048
• Status: Completed
• Phase: Early Phase 1
• First received: May 14, 2015
• Last updated: April 8, 2018
• Start date: March 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

Description:

This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Adult or child ages =5 years;

• Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;

• Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and

• Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

• instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Related Conditions & MeSH terms

• Acute Uncomplicated Appendicitis
• Appendicitis

Intervention

Drug:
• 1 gm IV ertapenem at enrollment

• 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

Procedure:
• Appendectomy

Locations

Country	Name	City	State
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Complications	The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.	30 days
Secondary	Recurrent appendicitis		30 days
Secondary	QOL outcomes		30 days