Restricted or Liberal Antibiotics After Appendectomy - Denver Health

NCT05002829 | Completed DMC

• 1 other identifier: 20191238
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appendicitis

Keywords

post-operative; antibiotics

Outcome Measures

Primary Outcomes (3)

• Number of participants with no antibiotic related adverse effects

  As assessed by treating physician

  Up to 40 days after appendicitis surgery

• Incidence of Infectious/Antibiotic Complications

  Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.

  Up to 30 days after appendicitis surgery

• Number of participant deaths

  As assessed by treating physician

  Up to 30 days after appendicitis surgery

Study Arms (2)

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 with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.

Other: Restricted Duration of SOC Antibiotic Use

Liberal Post-Operative Antibiotics Group

ACTIVE COMPARATOR

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.

Other: Liberal Duration of SOC Antibiotic Use

Interventions

Restricted Duration of SOC Antibiotic Use OTHER

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.

Restricted Post-Operative Antibiotics Group

Liberal Duration of SOC Antibiotic Use OTHER

Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Liberal 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) for simple or complicated (perforated or gangrenous) appendicitis
• 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 AIDS
• Heart failure
• Allergy to bupivacaine
• Unlikely to comply with treatment or follow-up
• Inpatient consultation for appendicitis
• Clinically suspected of sepsis based on Sepsis-3 definition
• Current use of antibiotics for other indications
• Uncontrolled hyperglycemia or Type 1 Diabetes
• Surgeon preference
• Patient preference
• Research team unavailable

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204-4507, United States

Location

Related Publications (6)

• Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162.

  PMID: 25992746 BACKGROUND

• Yeh DD, Eid AI, Young KA, Wild J, Kaafarani HMA, Ray-Zack M, Kana'an T, Lawless R, Cralley AL, Crandall M; EAST Appendicitis Study Group. Multicenter Study of the Treatment of Appendicitis in America: Acute, Perforated, and Gangrenous (MUSTANG), an EAST Multicenter Study. Ann Surg. 2021 Mar 1;273(3):548-556. doi: 10.1097/SLA.0000000000003661.

  PMID: 31663966 BACKGROUND

• Lawless RA, Cralley A, Qian S, Vasileiou G, Yeh DD; EAST Appendicitis Study Group. Antibiotics after Simple (Acute) Appendicitis are not Associated with Better Clinical Outcomes: A Post-Hoc Analysis of an EAST Multi-Center Study. Surg Infect (Larchmt). 2021 Jun;22(5):504-508. doi: 10.1089/sur.2019.348. Epub 2020 Sep 3.

  PMID: 32897168 BACKGROUND

• Bou Zein Eddine S, Dodgion CM, Qian S, Trevino C, De Moya MA, Yeh DD; EAST Appendicitis Research Group. Complicated Appendicitis: Are Extended Antibiotics Necessary? A Post Hoc Analysis of the EAST Appendicitis "MUSTANG" Study. J Surg Res. 2020 Mar;247:508-513. doi: 10.1016/j.jss.2019.09.054. Epub 2019 Dec 4.

  PMID: 31812337 BACKGROUND

• Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D, Chuang-Stein C, Cosgrove SE, Fowler VG Jr, Lautenbach E, Chambers HF. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25.

  PMID: 26113652 BACKGROUND

• Yeh DD, Hatton GE, Pedroza C, Pust G, Mantero A, Namias N, Kao LS. Complex And Simple Appendicitis: REstrictive or Liberal postoperative Antibiotic eXposure (CASA RELAX) using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR): study protocol for a randomized controlled trial. Trauma Surg Acute Care Open. 2022 Sep 16;7(1):e000931. doi: 10.1136/tsaco-2022-000931. eCollection 2022.

  PMID: 36148315 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel D Yeh, MD, MHPE

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: November 1, 2021
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)