Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

NCT05746520 | Completed DMC

• 1 other identifier: IRB00086118
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Conditions

Appendicitis Surgery

Keywords

post-operative antibiotics; acute appendicitis; complicated appendicitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30

Secondary Outcomes (1)

• Incidence of Infectious/Antibiotic Complications

  Day 30

Study Arms (4)

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.

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.

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.

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.

Other: Antibiotic

Interventions

Antibiotic OTHER

Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.

Also known as: antibiotics are per standard of care (SOC)

Liberal Duration of SOC Antibiotic Use; Liberal Post-Operative Antibiotics Group; Restricted Duration of SOC Antibiotic Use; Restricted Post-Operative Antibiotics Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Rafael Torres Fajardo, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: March 2, 2023
• Primary Completion: June 18, 2025
• Study Completion: July 21, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose

Locations

US (1)