Antibiotic Use After Appendectomy for Appendicitis

(CASA RELAX Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen by Daniel D Yeh, MD, MHPE

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Must not be taking: Steroids, Chemotherapy, Immunosuppressants, Antibiotics

Disqualifiers: Pregnancy, Immunocompromised, Heart failure, Sepsis, others

No Placebo Group

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{1 2 4 5 8}

Eligibility Criteria

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 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Liberal Duration of SOC Antibiotic Use (Other)
• Restricted Duration of SOC Antibiotic Use (Other)

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.

Participant Groups

Group I: Restricted Post-Operative Antibiotics Group Experimental Treatment 1 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 Group Active Control 1 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 Clinic Near You

Research Locations Nearby Select from list below to view details:

Ryder Trauma Center / Jackson Memorial Hospital Miami, FL

University of Louisville Louisville, KY

Texas Health Resources Fort Worth, TX

NYU Langone Brooklyn Brooklyn, NY

More Trial Locations

Who Is Running the Clinical Trial?

University of Miami Lead Sponsor

Denver Health and Hospital Authority Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. [2016] Optimal duration of antibiotic treatment to reduce infectious complications after an appendectomy for acute complicated appendicitis remains unclear.

2. United States pubmed.ncbi.nlm.nih.gov

Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis. [2017] Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively.

3. France pubmed.ncbi.nlm.nih.gov

[Can acute appendicitis be treated by antibiotics and in what conditions?]. [2009] The current treatment for acute appendicitis is an appendectomy. Several studies have, however, assessed the efficacy of an antibiotic for treating acute appendicitis that is either uncomplicated or complicated by local peritonitis. A meta-analysis in 2007 that collected the results of 44 prospective studies showed that antibiotics were efficacious in 92.8% of cases of appendicitis complicated by local peritonitis, with percutaneous drainage of an abscess when necessary. No predictive factor for failure was identified. The failure of antibiotic treatment did not increase morbidity. Over time and on the whole, the recurrence rate was only 8.9%. The risk of cancer of the appendix (1.5%) nonetheless led to the recommendation of an interval appendectomy for adults. Four randomized controlled trials have compared antibiotic treatment with an appendectomy for the treatment of uncomplicated acute appendicitis. The efficacy of the antibiotic treatment ranged from 86 to 100% and the recurrence rate from 10.4 to 35%. These studies have had various methodological impediments; however, too few patients were included (40 and 80 patients), or only a clinical diagnosis was made before inclusion, or important protocol violations occurred, in particular for almost half the patient in the antibiotic therapy group in the 2009 study. These problems prevent us from relying on these authors' findings. Antibiotics have a role in the initial treatment of acute appendicitis complicated by local peritonitis. In uncomplicated acute appendicitis, the methodological inadequacy of the currently available randomized trials makes it impossible to reach a definitive conclusion about the efficacy of antibiotics.

4. United States pubmed.ncbi.nlm.nih.gov

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis. [2023] Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making.

5. England pubmed.ncbi.nlm.nih.gov

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial. [2019] Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days.

6. United States pubmed.ncbi.nlm.nih.gov

Cost analysis of antibiotic therapy versus appendectomy for treatment of uncomplicated acute appendicitis: 5-year results of the APPAC randomized clinical trial. [2020] The efficacy and safety of antibiotic treatment for uncomplicated acute appendicitis has been established at long-term follow-up with the majority of recurrences shown to occur within the first year. Overall costs of antibiotics are significantly lower compared with appendectomy at short-term follow-up, but long-term durability of these cost savings is unclear. The study objective was to compare the long-term overall costs of antibiotic therapy versus appendectomy in the treatment of uncomplicated acute appendicitis in the APPAC (APPendicitis ACuta) trial at 5 years.

7. England pubmed.ncbi.nlm.nih.gov

2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial. [2023] The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs.

8. England pubmed.ncbi.nlm.nih.gov

Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. [2022] Antibiotic treatment after appendicectomy for complicated appendicitis aims to reduce postoperative infections. However, available data on the duration of treatment are limited. This study compared the difference in infectious complications between two protocols, involving either 3 or 5 days of postoperative antibiotic treatment.