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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.
Yeh, Daniel Dante; Hatton, Gabrielle E; Pedroza, Claudia; Pust, Gerd; Mantero, Alejandro; Namias, Nicholas; Kao, Lillian S.
Afiliación
  • Yeh DD; Surgery, Ernest E. Moore Shock Trauma Center / Denver Health, Denver, Colorado, USA.
  • Hatton GE; Department of Surgery, McGovern Medical School at UT Health Houston, Houston, Texas, USA.
  • Pedroza C; Department of Pediatrics, McGovern Medical School at UT Health Houston, Houston, Texas, USA.
  • Pust G; Surgery, Jackson Memorial Hospital, Miami, Florida, USA.
  • Mantero A; University of Miami Biostatistics Collaboration and Consulting Core, Miami, Florida, USA.
  • Namias N; Surgery, Jackson Memorial Hospital, Miami, Florida, USA.
  • Kao LS; Department of Surgery, McGovern Medical School at UT Health Houston, Houston, Texas, USA.
Trauma Surg Acute Care Open ; 7(1): e000931, 2022.
Article en En | MEDLINE | ID: mdl-36148315
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Idioma: En Revista: Trauma Surg Acute Care Open Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Idioma: En Revista: Trauma Surg Acute Care Open Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido