ClinicalTrials.gg
CompletedNCT05002829CASARELAXUpdated Jun 30, 2026

Restricted or Liberal Antibiotics After Appendectomy - Denver Health

An interventional study of Restricted Duration of SOC Antibiotic Use and Liberal Duration of SOC Antibiotic Use in Appendicitis, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
657
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Appendicitis

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Keywords

  • post-operative
  • antibiotics
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's enrollment of 657 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable to consent
  • Pregnant Women
  • Prisoners
  • as determined by clinical team, or patients actively receiving , chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
657 participants (actual)

Study arms

  • Experimental
    Restricted Post-Operative Antibiotics Group

    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

  • Active comparator
    Liberal Post-Operative Antibiotics Group

    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

  • OtherRestricted Duration of SOC Antibiotic Use

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

  • OtherLiberal Duration of SOC Antibiotic Use

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

06

What researchers measure

Primary outcomes

  1. Number of participants with no antibiotic related adverse effects

    As assessed by treating physician

    Time frame: Up to 40 days after appendicitis surgery

  2. 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.

    Time frame: Up to 30 days after appendicitis surgery

  3. Number of participant deaths

    As assessed by treating physician

    Time frame: Up to 30 days after appendicitis surgery

07

Study locations

1 site
  • Denver Health and Hospital Authority
    Denver, Colorado 80204-4507, United States
08

References and documents

Publications

  • 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. PubMed 25992746 ↗
  • 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. PubMed 31663966 ↗
  • 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. PubMed 32897168 ↗
  • 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. PubMed 31812337 ↗
  • 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. PubMed 26113652 ↗
  • 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. PubMed 36148315 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Jul 2025, 44 months.

Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 44 months is above that.

Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2021
First posted
Aug 12, 2021
StartActual
Nov 1, 2021
Primary completionActual
Jul 16, 2025
CompletionActual
Jul 16, 2025
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002829
Lead sponsor
Denver Health and Hospital Authority
Responsible party
Daniel Yeh (Professor of Surgery, Denver Health and Hospital Authority) — Principal investigator
First posted
Aug 12, 2021
Start date
Nov 1, 2021
Primary completion
Jul 16, 2025
Completion
Jul 16, 2025
Last update
Jun 30, 2026

Study contacts

Daniel D Yeh, MD, MHPE
principal investigator · Denver Health and Hospital Authority

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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