Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02447224

Enrollment

Registered

2015-05-18

Start date

2015-03-31

Completion date

2017-12-31

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Uncomplicated Appendicitis

Keywords

appendicitis, non operative management, appendectomy

Brief 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.

Detailed 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.

Interventions

DRUG1 gm IV ertapenem at enrollment

DRUG1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

PROCEDUREAppendectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Major Complications	30 days	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.

Secondary

Measure	Time frame
Recurrent appendicitis	30 days
QOL outcomes	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026