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Completed

NCT Number: NCT05746520

Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

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Key information

Conditions

Appendicitis Surgery 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

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

This is a single center, randomized controlled trial to determine 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.

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)
  • Willing and able to provide informed consent
  • 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 Acquired immunodeficiency syndrome (AIDS)
  • Heart Failure
  • Allergy to Bupivacaine
  • Unlikely to comply with treatment or follow-up
  • Inpatient consultation for appendicitis
  • Clinically suspected sepsis based on Sepsis-3 definition
  • Current use of antibiotics for other indications
  • Type 1 Diabetes or uncontrolled hyperglycemia

Treatment and study plan

Antibiotic

Other

Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.

Other names: antibiotics are per standard of care (SOC)

Primary outcomes

  1. Number of participants with no antibiotic related adverse effects

    Time frame: Day 30

    All subjects will be contacted at least 30 days after appendectomy by telephone if unable to contact subject, then electronic medical record will be reviewed. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.

Secondary outcomes

  1. Incidence of Infectious/Antibiotic Complications

    Time frame: Day 30

    All subjects will be monitored from consent until follow up at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
Nov 3, 2025

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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