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
Objectives After appendectomy for simple or complicated appendicitis, the optimal duration of postoperative antibiotics (postop abx) is unclear and great practice variability exists. We propose to compare restrictive versus liberal postop abx using a hierarchical composite endpoint which includes pa...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-03-01
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| Series: | Trauma Surgery & Acute Care Open |
| Online Access: | https://tsaco.bmj.com/content/7/1/e000931.full |
| _version_ | 1797776474645725184 |
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| author | Lillian S Kao Claudia Pedroza Nicholas Namias Gabrielle E Hatton Daniel Dante Yeh Gerd Pust Alejandro Mantero |
| author_facet | Lillian S Kao Claudia Pedroza Nicholas Namias Gabrielle E Hatton Daniel Dante Yeh Gerd Pust Alejandro Mantero |
| author_sort | Lillian S Kao |
| collection | DOAJ |
| description | Objectives After appendectomy for simple or complicated appendicitis, the optimal duration of postoperative antibiotics (postop abx) is unclear and great practice variability exists. We propose to compare restrictive versus liberal postop abx using a hierarchical composite endpoint which includes patient-centered outcomes and accounts for duration of antibiotic exposure.Methods/Design Participants with simple or complicated appendicitis undergoing appendectomy are randomly assigned to either restricted or liberal strategy. Eligible subjects declining randomization will be recruited to enroll in an observation only cohort. The primary endpoint is an ordinal scale of mutually exclusive clinical outcomes with within-category rankings determined by duration of antibiotic exposure. Subjects in both randomized and observation only cohorts will be analyzed as intention-to-treat, per-protocol, and as-treated. Exploratory Bayesian analyses will be performed.Conclusion The complex and simple appendicitis: restrictive or liberal postoperative antibiotic exposure multicenter randomized controlled trial will enroll surgical appendectomy patients and seeks to analyze if a strategy of restricted (compared with liberal) postoperative antibiotics results in similar clinical outcomes with the benefit of reduced antibiotic exposure.Trial registration number NCT05002829. |
| first_indexed | 2024-03-12T22:50:29Z |
| format | Article |
| id | doaj.art-cd214ab765e44d90af8a3539205bd93a |
| institution | Directory Open Access Journal |
| issn | 2397-5776 |
| language | English |
| last_indexed | 2024-03-12T22:50:29Z |
| publishDate | 2022-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Trauma Surgery & Acute Care Open |
| spelling | doaj.art-cd214ab765e44d90af8a3539205bd93a2023-07-20T13:30:07ZengBMJ Publishing GroupTrauma Surgery & Acute Care Open2397-57762022-03-017110.1136/tsaco-2022-000931Complex 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 trialLillian S Kao0Claudia Pedroza1Nicholas Namias2Gabrielle E Hatton3Daniel Dante Yeh4Gerd Pust5Alejandro Mantero63 Department of Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, Texas, USADepartment of Pediatrics, McGovern Medical School at UT Health Houston, Houston, Texas, USADeWitt Daughtry Family Department of Surgery, Ryder Trauma Center, Jackson Memorial Hospital, University of Miami Miller School of Medicine, Miami, Florida, USADepartment of Surgery, McGovern Medical School at UT Health Houston, Houston, Texas, USASurgery, Ernest E. Moore Shock Trauma Center / Denver Health, Denver, Colorado, USASurgery, Jackson Memorial Hospital, Miami, Florida, USAUniversity of Miami Biostatistics Collaboration and Consulting Core, Miami, Florida, USAObjectives After appendectomy for simple or complicated appendicitis, the optimal duration of postoperative antibiotics (postop abx) is unclear and great practice variability exists. We propose to compare restrictive versus liberal postop abx using a hierarchical composite endpoint which includes patient-centered outcomes and accounts for duration of antibiotic exposure.Methods/Design Participants with simple or complicated appendicitis undergoing appendectomy are randomly assigned to either restricted or liberal strategy. Eligible subjects declining randomization will be recruited to enroll in an observation only cohort. The primary endpoint is an ordinal scale of mutually exclusive clinical outcomes with within-category rankings determined by duration of antibiotic exposure. Subjects in both randomized and observation only cohorts will be analyzed as intention-to-treat, per-protocol, and as-treated. Exploratory Bayesian analyses will be performed.Conclusion The complex and simple appendicitis: restrictive or liberal postoperative antibiotic exposure multicenter randomized controlled trial will enroll surgical appendectomy patients and seeks to analyze if a strategy of restricted (compared with liberal) postoperative antibiotics results in similar clinical outcomes with the benefit of reduced antibiotic exposure.Trial registration number NCT05002829.https://tsaco.bmj.com/content/7/1/e000931.full |
| spellingShingle | Lillian S Kao Claudia Pedroza Nicholas Namias Gabrielle E Hatton Daniel Dante Yeh Gerd Pust Alejandro Mantero 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 Surgery & Acute Care Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://tsaco.bmj.com/content/7/1/e000931.full |
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