The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial

Completed · Not applicable

Conditions studied: Appendicitis

In brief

For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent studies from Europe have challenged the notion that surgery is the best option, showing that antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out of 4 patients and without safety issues for up to one year of follow up. Despite these results, it remains to be determined if the antibiotic strategy is as good as an appendectomy for the outcomes that most patients care about. The Patient-Centered Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will be the first American, and largest-ever randomized trial of the issue and its results should help surgeons and patients make more informed healthcare decisions.

Key facts

Study ID

NCT02800785

Run by

University of Washington

People needed

1552

Starts

2016-05-01

Expected to finish

2021-09-01

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult ≥18 years;
• Clinical diagnosis of acute uncomplicated appendicitis (AUA) established by clinical care team, supported by any of the following usual care radiological tests (computed tomography (CT), ultrasound (US), and/or magnetic resonance imaging (MRI)). AUA is defined by the usual signs, symptoms, and imaging finding of appendicitis without:
• Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
• Radiologic findings of :
• i. Free air; ii. Walled off fluid collection concerning for an abscess; iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e., more than trace fluid); or iv. Extent of inflammation or adjacent organ involvement on radiologic imaging such that appendectomy is relatively contraindicated.
• Ability to provide written or electronic informed consent in English or Spanish.

You may not qualify if…

• 1. Unable or unwilling to return or be contacted for clinical follow-up visits and/or research surveys;
• Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
• Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension);
• Conditions with altered immune response or at risk for bacterial seeding;
• Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs, active chemotherapy or plans for chemotherapy in the following 30 days, or known acquired immune deficiency syndrome (AIDS) [cluster of differentiation 4 (CD4) count <200 or AIDS-defining illness within the last year] assessed by patient history);
• Uncompensated liver failure;
• Taking medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
• Malignancy, not in remission (ongoing chemotherapy patients excluded);
• Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
• Expected concurrent hemodialysis, peritoneal dialysis, or treatments using indwelling venous catheters;
• Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve);
• Indwelling Left Ventricular Assist Device (LVAD);
• Patients with another infection (e.g., pneumonia, urinary tract infection) that requires treatment with another antibiotic at baseline/screening;
• Concurrent illness that would otherwise mandate hospitalization outside of appendicitis and associated symptoms at baseline/screening;
• Imaging findings of any of the following:
• Appendiceal soft-tissue mass;
• Imaging features of mucocele or tumor (e.g., appendix measuring ≥ 15mm in diameter and no other CT evidence of appendicitis);
• Concern for carcinomatosis on imaging; or
• Severe allergy or reaction (e.g., immediate urticaria or anaphylaxis) to all of the proposed antibiotics;
• Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
• Abdominal/pelvic surgery in the past month; or
• More than seven hours have transpired since the patient received the first parenteral dose of antibiotics.

Where it is running

• Olive View-UCLA Medical Center — Sylmar, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Maine Medical Center — Portland, Maine, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Michigan Medicine- University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• New York University - Bellevue Hospital — New York, New York, United States
• New York University - Tisch Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Lyndon B Johnson- Harris Health — Houston, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Providence Regional Medical Center Everett — Everett, Washington, United States
• Harborview Medical Center — Seattle, Washington, United States
• Virginia Mason University Village Medical Center — Seattle, Washington, United States
• Swedish Medical Center- First Hill — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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