2275 Participants Needed

Antibiotic Use After Appendectomy for Appendicitis

(CASA RELAX Trial)

Recruiting at 12 trial locations
DD
Overseen ByDaniel D Yeh, MD, MHPE
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What safety data exists for antibiotic use after appendectomy for appendicitis?

The safety of antibiotic use for appendicitis has been established, showing it to be noninferior to appendectomy based on self-reported health status at 30 days. Long-term follow-up from the APPAC trial confirms the safety of antibiotics for uncomplicated appendicitis, with most recurrences occurring within the first year. Studies are ongoing to determine the optimal duration of antibiotics post-appendectomy, with shorter courses potentially being as effective and reducing side effects and costs.12345

Is the drug used after appendectomy for appendicitis a promising treatment?

Yes, using antibiotics after an appendectomy for appendicitis is promising because it helps prevent infections. Studies suggest that shorter courses of antibiotics might be just as effective as longer ones, which could help reduce the risk of antibiotic resistance.12367

What data supports the idea that Antibiotic Use After Appendectomy for Appendicitis is an effective drug?

The available research shows that antibiotics can be effective after an appendectomy for appendicitis, especially when the condition is complicated. One study found that antibiotics were successful in 92.8% of cases with local peritonitis, a type of complication. Another study suggests that using antibiotics is safe and can be as effective as surgery in some cases, based on patients' health status 30 days after treatment. However, there is no clear agreement on how long antibiotics should be used, with some studies suggesting shorter courses might be just as effective as longer ones. Overall, antibiotics can be a good option, but more research is needed to determine the best way to use them.12378

Who Is on the Research Team?

DD

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

I am scheduled for an appendectomy, whether my appendix is ruptured or not.
I have a working phone or reliable way to be contacted after leaving the hospital.

Exclusion Criteria

I have high blood sugar that is not under control or I have Type 1 Diabetes.
Prisoners
I am unable to give consent by myself.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1-4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of infectious/antibiotic complications and adverse effects

40 days

What Are the Treatments Tested in This Trial?

Interventions

  • Liberal Duration of SOC Antibiotic Use
  • Restricted Duration of SOC Antibiotic Use
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention
Group II: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Denver Health and Hospital Authority

Lead Sponsor

Trials
106
Recruited
403,000+

Published Research Related to This Trial

In a study of 1975 patients undergoing laparoscopic appendectomy for acute complicated appendicitis, extending antibiotic treatment from 3 days to 5 days did not significantly reduce the risk of infectious complications or intra-abdominal abscesses.
The only independent risk factor for developing infectious complications was the perforation of the appendix, suggesting that shorter antibiotic courses may be safe for nonperforated complicated appendicitis.
Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis.van Rossem, CC., Schreinemacher, MH., van Geloven, AA., et al.[2016]
This study aims to determine if a short course of 48 hours of postoperative antibiotics is as effective as the standard 5-day course in preventing infectious complications after appendectomy in patients with complex appendicitis, involving 1066 participants aged 8 years and older.
If the 48-hour antibiotic treatment is found to be non-inferior, it could lead to changes in clinical guidelines, reducing unnecessary antibiotic use and addressing concerns about antimicrobial resistance.
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial.van den Boom, AL., de Wijkerslooth, EML., van Rosmalen, J., et al.[2019]
Antibiotics for treating appendicitis are safe and can be as effective as surgery, with 21% of patients who started antibiotics undergoing appendectomy within 30 days, highlighting the need for personalized treatment decisions.
Factors such as female sex, a wider appendiceal diameter, and the presence of an appendicolith significantly increased the likelihood of needing surgery within 30 days, while traditional indicators of appendicitis severity did not correlate with this outcome.
Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.Monsell, SE., Voldal, EC., Davidson, GH., et al.[2023]

Citations

Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. [2016]
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial. [2019]
Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis. [2023]
Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis. [2017]
[Can acute appendicitis be treated by antibiotics and in what conditions?]. [2009]
Cost analysis of antibiotic therapy versus appendectomy for treatment of uncomplicated acute appendicitis: 5-year results of the APPAC randomized clinical trial. [2020]
2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial. [2023]
Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. [2022]
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