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}

Research Team

Daniel D Yeh, MD, MHPE

Principal Investigator

Denver Health and Hospital Authority

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

Donna Lynne

Denver Health and Hospital Authority

Chief Executive Officer since 2022

DrPH from Columbia University

Dr. Steven G. Federico

Denver Health and Hospital Authority

Chief Medical Officer

MD from University of Colorado

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. van Rossem, CC., Schreinemacher, MH., van Geloven, AA., et al.[2016]

In a study of 1,343 patients who underwent laparoscopic surgery for complicated appendicitis, a standardized 5-day antibiotic regimen (cefuroxime and metronidazole) was found to be as effective as a non-standardized 10-day regimen in preventing surgical site infections (SSIs).

The 5-day treatment not only maintained similar infection rates but also resulted in shorter hospital stays and lower medical costs, suggesting it is a more efficient option for post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis. Park, HC., Kim, MJ., Lee, BH.[2017]

Antibiotics are effective in treating acute appendicitis complicated by local peritonitis, with a success rate of 92.8% and a low recurrence rate of 8.9%, indicating they can be a viable alternative to surgery in these cases.

For uncomplicated acute appendicitis, the evidence from randomized controlled trials is insufficient due to methodological issues, making it unclear whether antibiotics can be reliably recommended as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can acute appendicitis be treated by antibiotics and in what conditions?]. Vons, C.[2009]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis. Monsell, SE., Voldal, EC., Davidson, GH., et al.[2023]

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.

NCBI (Pubmed)

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. van den Boom, AL., de Wijkerslooth, EML., van Rosmalen, J., et al.[2019]

In a study involving 530 adult patients with uncomplicated acute appendicitis, antibiotic treatment was found to be significantly cheaper than appendectomy over a 5-year period, saving €1545 per patient.

At the 5-year follow-up, 61% of patients treated with antibiotics did not require surgery, indicating that antibiotics can be an effective long-term treatment option for uncomplicated acute appendicitis.

NCBI (Pubmed)

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. Haijanen, J., Sippola, S., Tuominen, R., et al.[2020]

A study involving 1066 patients with complex appendicitis found that 2 days of postoperative intravenous antibiotics is as effective as 5 days in preventing infectious complications and mortality, with a non-inferiority margin of 7.5%.

Patients receiving the shorter 2-day antibiotic treatment experienced significantly fewer adverse effects (9% vs. 22%) compared to those on the 5-day regimen, suggesting a safer and more efficient approach to postoperative care.

NCBI (Pubmed)

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. de Wijkerslooth, EML., Boerma, EG., van Rossem, CC., et al.[2023]

In a study of 1143 patients who underwent appendicectomy for acute appendicitis, 3 days of postoperative antibiotic treatment was found to be as effective as 5 days in preventing infections, such as intra-abdominal abscesses and wound infections.

The study suggests that shorter antibiotic courses may be sufficient for patients with complicated appendicitis, potentially reducing unnecessary medication exposure without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. van Rossem, CC., Schreinemacher, MH., Treskes, K., et al.[2022]

References

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

Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. [2016]

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]

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

[Can acute appendicitis be treated by antibiotics and in what conditions?]. [2009]

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

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis. [2023]

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]

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]

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]

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

Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. [2022]