Antibiotic Use After Appendectomy for Appendicitis
(CASA RELAX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether reducing antibiotics after appendicitis surgery can lower side effects while maintaining patient safety. It compares the standard longer antibiotic use (Liberal Duration of SOC Antibiotic Use) with a shorter duration (Restricted Duration of SOC Antibiotic Use). Individuals who have undergone an appendectomy for either simple or complicated appendicitis (when the appendix is swollen or burst) may qualify if they can be easily contacted after discharge.
As an unphased trial, this study provides patients an opportunity to contribute to important research that could enhance post-surgery care.
Do I have to stop taking my current medications for this trial?
The protocol does not specify if you need to stop taking your current medications, but if you are currently using antibiotics for other reasons, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using fewer antibiotics after appendicitis surgery might be as safe as using more. For instance, studies found that taking antibiotics for only two days after complex appendicitis poses no greater risk of infection or death within 90 days than taking them for five days. This suggests that a shorter antibiotic course can still protect patients.
Moreover, another study found that the rate of serious side effects was similar between those who took antibiotics and those who underwent surgery for appendicitis. This indicates that antibiotics are generally well-tolerated, regardless of duration. Thus, using fewer antibiotics after surgery could reduce side effects while maintaining safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how long antibiotics should be used after an appendectomy, which could lead to less antibiotic use without impacting recovery. Currently, standard care often involves using antibiotics for several days, especially in complicated cases. The trial compares a "liberal" approach, with up to four days of antibiotics, to a "restricted" approach, which limits antibiotics to up to 24 hours or none at all. This could reduce antibiotic resistance and side effects while maintaining effective treatment, a significant benefit for patient care.
What evidence suggests that this trial's treatments could be effective for appendicitis?
This trial will compare different durations of antibiotic use after appendectomy for appendicitis. Research has shown that shorter antibiotic courses after appendix removal might still effectively prevent infections. In the Liberal Post-Operative Antibiotics Group, participants with complicated appendicitis will receive 4 days of post-operative antibiotics, while those with simple appendicitis will receive 24 hours. In the Restricted Post-Operative Antibiotics Group, participants with complicated appendicitis will receive up to 24 hours of antibiotics, and those with simple appendicitis will not receive post-operative antibiotics. Studies have found that shorter antibiotic treatments, such as 3 days instead of 5, work just as well in preventing infections after surgery for complicated cases. Specifically, another study found that 2 days of antibiotics were as effective as 5 days in preventing complications and death in complex appendicitis cases. For simple appendicitis, most patients have been successfully treated with antibiotics alone. Overall, shorter antibiotic treatments seem effective and may also reduce side effects and costs.24567
Who Is on the Research Team?
Daniel D Yeh, MD, MHPE
Principal Investigator
Denver Health and Hospital Authority
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive post-operative antibiotics based on the complexity of appendicitis: 24 hours for simple cases and up to 4 days for complicated cases
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of infectious/antibiotic complications and adverse effects
What Are the Treatments Tested in This Trial?
Interventions
- Liberal Duration of SOC Antibiotic Use
- Restricted Duration of SOC Antibiotic Use
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Denver Health and Hospital Authority
Lead Sponsor