COMPLETED

Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2021-11-01

Study Completion:2025-07-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05002829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Daniel D Yeh, MD, MHPE

PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Study Locations (Sites)

Denver Health and Hospital Authority

Denver, Colorado, 80204-4507

United States

Collaborators and Investigators

Sponsor: Denver Health and Hospital Authority

Daniel D Yeh, MD, MHPE, PRINCIPAL_INVESTIGATOR, Denver Health and Hospital Authority

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01

Study Completion Date2025-07-16

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2025-07-16

Terms related to this study

Keywords Provided by Researchers

post-operative
antibiotics

Additional Relevant MeSH Terms

Appendicitis