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Restricted or Liberal Antibiotics After Appendectomy - Denver Health (CASA RELAX)

Primary Purpose

Appendicitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted Duration of SOC Antibiotic Use
Liberal Duration of SOC Antibiotic Use
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring post-operative, antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Denver Health and Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Restricted Post-Operative Antibiotics Group

Liberal Post-Operative Antibiotics Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with no antibiotic related adverse effects
As assessed by treating physician
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.
Number of participant deaths
As assessed by treating physician

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
March 15, 2023
Sponsor
Denver Health and Hospital Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05002829
Brief Title
Restricted or Liberal Antibiotics After Appendectomy - Denver Health
Acronym
CASA RELAX
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): A Randomized Controlled Trial at Denver Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
post-operative, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Restricted Post-Operative Antibiotics Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Liberal Post-Operative Antibiotics Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Restricted Duration of SOC Antibiotic Use
Intervention Description
Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
Intervention Type
Other
Intervention Name(s)
Liberal Duration of SOC Antibiotic Use
Intervention Description
Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.
Primary Outcome Measure Information:
Title
Number of participants with no antibiotic related adverse effects
Description
As assessed by treating physician
Time Frame
Up to 40 days after appendicitis surgery
Title
Incidence of Infectious/Antibiotic Complications
Description
Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
Time Frame
Up to 30 days after appendicitis surgery
Title
Number of participant deaths
Description
As assessed by treating physician
Time Frame
Up to 30 days after appendicitis surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel D Yeh, MD, MHPE
Organizational Affiliation
Denver Health and Hospital Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25992746
Citation
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. Erratum In: N Engl J Med. 2018 Jan 25;:null.
Results Reference
background
PubMed Identifier
31663966
Citation
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.
Results Reference
background
PubMed Identifier
32897168
Citation
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.
Results Reference
background
PubMed Identifier
31812337
Citation
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.
Results Reference
background
PubMed Identifier
26113652
Citation
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. Erratum In: Clin Infect Dis. 2023 Jan 6;76(1):182.
Results Reference
background
PubMed Identifier
36148315
Citation
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.
Results Reference
derived

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Restricted or Liberal Antibiotics After Appendectomy - Denver Health

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