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临床试验/NCT04827888
NCT04827888已完成不适用

The Effect Of BMI On Thirty-day Postoperative Morbidities And Mortality For The Most Common Orthopaedic Procedures

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 76,189 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76,189
试验地点
1
主要终点
Composite morbidity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • All patients whose BMI was not reported

结局指标

主要结局

Composite morbidity

时间窗: within the 30 days following the surgery

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.

次要结局

  • mortality(within the 30 days following the surgery)
  • wound(within the 30 days following the surgery)
  • cardiac(within the 30 days following the surgery)
  • bleeding(within the 30 days following the surgery)
  • respiratory(within the 30 days following the surgery)
  • thromboembolism(within the 30 days following the surgery)
  • neurological(within the 30 days following the surgery)
  • Re-op(within the 30 days following the surgery)
  • urinary(within the 30 days following the surgery)
  • sepsis(within the 30 days following the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhyeddine Al-Taki

Assistant Professor of Clinical Surgery

American University of Beirut Medical Center

研究点 (1)

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