Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)
2021年4月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
76189
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beirut、レバノン、11-236
- American University of Beirut Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Representative of the population from ACS-NSQIP
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite morbidity
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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mortality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Muhyeddine Al-Taki、American University of Beirut Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年1月1日
一次修了 (実際)
2015年12月31日
研究の完了 (実際)
2020年12月31日
試験登録日
最初に提出
2021年3月30日
QC基準を満たした最初の提出物
2021年3月30日
最初の投稿 (実際)
2021年4月1日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月5日
QC基準を満たした最後の更新が送信されました
2021年4月1日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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