Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)
1 de abril de 2021 atualizado por: Muhyeddine Al-Taki, American University of Beirut Medical Center
The Effect Of BMI On Thirty-day Postoperative Morbidities And Mortality For The Most Common Orthopaedic Procedures
Obesity is associated with poor surgical outcome and complications.
The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries.
Therefore, we aim to determine the effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries using a retrospective cohort study design.
The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the procedure specific, independent-effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries.
The study is a retrospective cohort study. The subjects will be the individuals undergoing one of first 25 most commonly performed orthopedic surgeries, whose information is derived form the de-identified patients' data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. The primary outcome will be composite post-operative morbidity. Specific morbidities will also be evaluated including cardiovascular, vascular and renal complications, length-of-stay (LOS), and the need for re-intervention and readmission, as well as 30-day mortality. Descriptive statistics and multivariable regression models will assess the independent-effect of BMI on outcomes.
The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities. The surgeon will be able to better counsel obese patients and devise a better surgical plan to prevent or deal with the expected outcomes.
Tipo de estudo
Observacional
Inscrição (Real)
76189
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beirut, Líbano, 11-236
- American University of Beirut Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Representative of the population from ACS-NSQIP
Descrição
Inclusion Criteria:
- The inclusion and exclusion criteria are the same as that of ACS-NSQIP database.
- All patients who have undergone any of the 25 most common orthopedic procedures as primary procedure as identified through the CPT codes
Exclusion Criteria:
- All patients whose BMI was not reported
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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underweight
patients who underwent one of the 25 common orthopaedic surgeries and have a body mass index (BMI) of <18.5kg/m2
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One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
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normal-weight
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 18.5kg/m2 and 24.9kg/m2
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One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
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overweight
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 25kg/m2 and 29.9kg/m2
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One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
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mildly obese
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 30kg/m2 and 34.9kg/m2
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One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
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moderately-to-severely obese
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2
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One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Composite morbidity
Prazo: within the 30 days following the surgery
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Composite morbidity is defined as the presence of any of the specific morbidities during the 30-days following surgery as recorded in the ACS-NSQIP database.
The odds ratio of composite morbidity for each BMI group will be calculated as compared to normal-weight group.
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within the 30 days following the surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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mortality
Prazo: within the 30 days following the surgery
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odds ratio of mortality within the 30-days following the surgery for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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wound
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of surgical wound for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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cardiac
Prazo: within the 30 days following the surgery
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specific morbidity of cardiac complication for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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respiratory
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of respiratory complication
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within the 30 days following the surgery
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urinary
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of urinary complication for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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neurological
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of neurological (CNS) complication for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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thromboembolism
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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sepsis
Prazo: within the 30 days following the surgery
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odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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bleeding
Prazo: within the 30 days following the surgery
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odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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Re-op
Prazo: within the 30 days following the surgery
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odds ratio of need for re-admission/re-operation for each BMI group as compared to normal-weight group
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within the 30 days following the surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Muhyeddine Al-Taki, American University of Beirut Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2012
Conclusão Primária (Real)
31 de dezembro de 2015
Conclusão do estudo (Real)
31 de dezembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
30 de março de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de março de 2021
Primeira postagem (Real)
1 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 20210330BMI
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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