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Antibiotic Use After Appendectomy for Appendicitis (CASA RELAX Trial)
N/A
Waitlist Available
Led By Daniel D Yeh, MD, MHPE
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after appendicitis surgery
Awards & highlights
CASA RELAX Trial Summary
This trial will test if using less antibiotics after appendicitis surgery can lower the chance of negative effects from antibiotics, while still keeping patients safe.
Who is the study for?
This trial is for adults over 18 who are having their appendix removed due to appendicitis. They must have a reliable way to be contacted after leaving the hospital. People with uncontrolled diabetes, pregnant women, prisoners, those unable to follow treatment plans or give consent, immunocompromised individuals, and patients on current antibiotics for other conditions cannot participate.Check my eligibility
What is being tested?
The study is testing if using antibiotics for a shorter (restricted) or longer (liberal) time after appendectomy surgery affects patient safety and reduces side effects linked with antibiotic use. The goal is to find out whether less antibiotic use can still keep patients safe post-surgery.See study design
What are the potential side effects?
Potential side effects from different durations of antibiotic use may include allergic reactions, gastrointestinal issues like diarrhea or nausea, increased risk of infection resistance to antibiotics, and possibly others depending on individual health conditions.
CASA RELAX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for an appendectomy, whether my appendix is ruptured or not.
CASA RELAX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after appendicitis surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after appendicitis surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Infectious/Antibiotic Complications
Number of participant deaths
Number of participants with no antibiotic related adverse effects
CASA RELAX Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Group II: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
898 Previous Clinical Trials
407,376 Total Patients Enrolled
Denver Health and Hospital AuthorityLead Sponsor
101 Previous Clinical Trials
398,122 Total Patients Enrolled
Daniel D Yeh, MD, MHPEPrincipal InvestigatorDenver Health and Hospital Authority
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have high blood sugar that is not under control or I have Type 1 Diabetes.I am unable to give consent by myself.I am in the hospital for appendicitis.I prefer this treatment option.I am scheduled for an appendectomy, whether my appendix is ruptured or not.My surgeon has a preferred method for my surgery.I am immunocompromised due to medication, a condition, or treatment I am receiving.I have a working phone or reliable way to be contacted after leaving the hospital.I am currently taking antibiotics for a condition other than cancer.I have heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Liberal Post-Operative Antibiotics Group
- Group 2: Restricted Post-Operative Antibiotics Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites are engaged in the implementation of this trial?
"This clinical trial is recruiting participants at a variety of locations, including Denver Health and Hospital Authority in Denver, Colorado, Carolinas Medical Center in Charlotte, North carolina, University of California San Francisco in San Francisco, California as well as 13 additional sites."
Answered by AI
Is there still capacity to include more participants in this experiment?
"The trial is no longer recruiting, as evidenced by its last update on August 29th 2022. Despite this, clinicaltrials.gov reveals that there are 31 different initiatives currently seeking volunteers for their respective studies."
Answered by AI
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