Appendicitis SurgeryNCT05746520
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health
A study testing Antibiotic in people with Appendicitis Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis Surgery
- What is being tested?
- Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Planned appendectomy (laparoscopic or open)
- Willing and able to provide informed consent
- Working telephone number or reliable method to contact patient after hospital discharge
Who cannot join
- Unable to consent
- Pregnant Women
- Prisoners
- immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage Acquired immunodeficiency syndrome (AIDS)
- Heart Failure
- Allergy to Bupivacaine
Show all 11Show fewer
- Unlikely to comply with treatment or follow-up
- Inpatient consultation for appendicitis
- Clinically suspected sepsis based on Sepsis-3 definition
- Current use of antibiotics for other indications
- Type 1 Diabetes or uncontrolled hyperglycemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
Read the detailed description
This is a single center, randomized controlled trial to determine 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.
- Conditions
- Appendicitis Surgery
- Being tested
- Antibiotic
- Keywords
- post-operative antibiotics, acute appendicitis, complicated appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticOther
Also called antibiotics are per standard of care (SOC)
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
| Study group | Role | What they receive |
|---|---|---|
| Restricted Post-Operative Antibiotics Group | Experimental | Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics. Receives: Other: Antibiotic |
| Restricted Duration of SOC Antibiotic Use | Other | Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively. Receives: Other: Antibiotic |
| Liberal Post-Operative Antibiotics Group | Active comparator | Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics. Receives: Other: Antibiotic |
| Liberal Duration of SOC Antibiotic Use | Other | Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively. Receives: Other: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with no antibiotic related adverse effects
All subjects will be contacted at least 30 days after appendectomy by telephone if unable to contact subject, then electronic medical record will be reviewed. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.
Measured: Day 30
Secondary outcomes (1)
Incidence of Infectious/Antibiotic Complications
All subjects will be monitored from consent until follow up at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start2 Mar 2023
- Primary completion18 Jun 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Torres Fajardo, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746520
- Sponsor's protocol ID
- IRB00086118
- Status last verified
- Jan 2025
- First submitted
- 16 Feb 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data will be shared with Denver health and combined with data from other independent sites for final analysis
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
- ClinicalTrials.gov ID
- NCT05746520
- Acronym / sponsor ID
- IRB00086118
- Conditions
- Appendicitis Surgery
- Keywords
- post-operative antibiotics, acute appendicitis, complicated appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
Detailed description
This is a single center, randomized controlled trial to determine 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Restricted Post-Operative Antibiotics Group | Experimental | Other: AntibioticParticipants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics. |
| Restricted Duration of SOC Antibiotic Use | Other | Other: AntibioticUse of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively. |
| Liberal Post-Operative Antibiotics Group | Active comparator | Other: AntibioticParticipants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics. Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics. |
| Liberal Duration of SOC Antibiotic Use | Other | Other: AntibioticUse of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Planned appendectomy (laparoscopic or open)
- Willing and able to provide informed consent
- Working telephone number or reliable method to contact patient after hospital discharge
Key exclusion criteria (11 listed)
- Unable to consent
- Pregnant Women
- Prisoners
- immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage Acquired immunodeficiency syndrome (AIDS)
- Heart Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticAlso: antibiotics are per standard of care (SOC)Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study. | Other | Liberal Duration of SOC Antibiotic Use, Liberal Post-Operative Antibiotics Group, Restricted Duration of SOC Antibiotic Use, Restricted Post-Operative Antibiotics Group |
Primary outcome
Number of participants with no antibiotic related adverse effects
Time frame: Day 30
All subjects will be contacted at least 30 days after appendectomy by telephone if unable to contact subject, then electronic medical record will be reviewed. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.
1 secondary outcome
Incidence of Infectious/Antibiotic Complications
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: Yes. de-identified data will be shared with Denver health and combined with data from other independent sites for final analysis
Related trials for Appendicitis Surgery
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
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Video-Based Grading of Intraoperative Adverse Events in Pediatric Laparoscopic Appendectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Torres Fajardo, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic in people with Appendicitis Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with no antibiotic related adverse effects (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.