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OpenTrials
Completed

NCT Number: NCT05002829

Restricted or Liberal Antibiotics After Appendectomy - Denver Health

The purpose of this study is to see if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health and Hospital Authority

Denver, Colorado, 80204-4507, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
  • Working telephone number or reliable method to contact patient after hospital discharge

Exclusion criteria

  • Unable to consent
  • Pregnant Women
  • Prisoners
  • Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
  • Heart failure
  • Allergy to bupivacaine
  • Unlikely to comply with treatment or follow-up
  • Inpatient consultation for appendicitis
  • Clinically suspected of sepsis based on Sepsis-3 definition
  • Current use of antibiotics for other indications
  • Uncontrolled hyperglycemia or Type 1 Diabetes
  • Surgeon preference
  • Patient preference
  • Research team unavailable

Treatment and study plan

Restricted Duration of SOC Antibiotic Use

Other

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.

Liberal Duration of SOC Antibiotic Use

Other

Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Primary outcomes

  1. Number of participants with no antibiotic related adverse effects

    Time frame: Up to 40 days after appendicitis surgery

    As assessed by treating physician

  2. Incidence of Infectious/Antibiotic Complications

    Time frame: Up to 30 days after appendicitis surgery

    Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.

  3. Number of participant deaths

    Time frame: Up to 30 days after appendicitis surgery

    As assessed by treating physician

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR): A Randomized Controlled Trial at Denver Health

Acronym: CASARELAX

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2021
Registry last updated
Jun 30, 2026

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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