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Open Access

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

Daniel Dante Yeh, Gabrielle E Hatton, Claudia Pedroza, Gerd Pust, Alejandro Mantero, Nicholas Namias, Lillian S Kao
DOI: 10.1136/tsaco-2022-000931 Published 16 September 2022
Daniel Dante Yeh
1Surgery, Ernest E. Moore Shock Trauma Center / Denver Health, Denver, Colorado, USA
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  • ORCID record for Daniel Dante Yeh
Gabrielle E Hatton
2Department of Surgery, McGovern Medical School at UT Health Houston, Houston, Texas, USA
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Claudia Pedroza
3Department of Pediatrics, McGovern Medical School at UT Health Houston, Houston, Texas, USA
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Gerd Pust
4Surgery, Jackson Memorial Hospital, Miami, Florida, USA
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Alejandro Mantero
5University of Miami Biostatistics Collaboration and Consulting Core, Miami, Florida, USA
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Nicholas Namias
4Surgery, Jackson Memorial Hospital, Miami, Florida, USA
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Lillian S Kao
2Department of Surgery, McGovern Medical School at UT Health Houston, Houston, Texas, USA
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Article Figures & Data

Tables

  • Table 1

    Complicated appendicitis 1:1 propensity score matched MUSTANG dataset assigned to primary endpoint ordinal scale

    DOORMatched population
    Treatment<24>24
    188.7%70.8%
    21.4%11.1%
    34.2%1.4%
    42.8%8.3%
    54.2%4.2%
    61.4%2.8%
    71.4%1.4%
    • MUSTANG, Multicenter Study of the Treatment of Appendicitis in North America: Acute, Perforated, and Gangrenous.

  • Table 2

    Combinations of enrollment sites (cluster) and subjects per site

    ClustersEvents per clusterTotal eventsPatients per clusterPatients per cluster+15% attritionPower
    301530048550.84
    202040063720.804
    252050063720.876
    302060063720.906
    152537579910.809
    202520079910.842
    252562579910.927
    1530450951090.857
    10353501111280.818
    15355251111280.916
    10404001261450.836
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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
Daniel Dante Yeh, Gabrielle E Hatton, Claudia Pedroza, Gerd Pust, Alejandro Mantero, Nicholas Namias, Lillian S Kao
Trauma Surg Acute Care Open Sep 2022, 7 (1) e000931; DOI: 10.1136/tsaco-2022-000931

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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
Daniel Dante Yeh, Gabrielle E Hatton, Claudia Pedroza, Gerd Pust, Alejandro Mantero, Nicholas Namias, Lillian S Kao
Trauma Surg Acute Care Open Sep 2022, 7 (1) e000931; DOI: 10.1136/tsaco-2022-000931
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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
Daniel Dante Yeh, Gabrielle E Hatton, Claudia Pedroza, Gerd Pust, Alejandro Mantero, Nicholas Namias, Lillian S Kao
Trauma Surgery & Acute Care Open Sep 2022, 7 (1) e000931; DOI: 10.1136/tsaco-2022-000931
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