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Completed

NCT Number: NCT02447224

Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

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.

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Key information

Conditions

Acute Uncomplicated Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1 gm IV ertapenem at enrollment

Drug

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

Drug

Appendectomy

Procedure

Primary outcomes

  1. Major Complications

    Time frame: 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 outcomes

  1. Recurrent appendicitis

    Time frame: 30 days

  2. QOL outcomes

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Olive View-UCLA Education & Research Institute

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
May 18, 2015
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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