Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)
1. dubna 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
76189
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
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Beirut, Libanon, 11-236
- American University of Beirut Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Representative of the population from ACS-NSQIP
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Composite morbidity
Časové okno: 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.
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within the 30 days following the surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
mortality
Časové okno: within the 30 days following the surgery
|
odds ratio of mortality within the 30-days following the surgery for each BMI group as compared to normal-weight group
|
within the 30 days following the surgery
|
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wound
Časové okno: within the 30 days following the surgery
|
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
Časové okno: within the 30 days following the surgery
|
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
Časové okno: 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
Časové okno: within the 30 days following the surgery
|
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
Časové okno: within the 30 days following the surgery
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Muhyeddine Al-Taki, American University of Beirut Medical Center
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2012
Primární dokončení (Aktuální)
31. prosince 2015
Dokončení studie (Aktuální)
31. prosince 2020
Termíny zápisu do studia
První předloženo
30. března 2021
První předloženo, které splnilo kritéria kontroly kvality
30. března 2021
První zveřejněno (Aktuální)
1. dubna 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. dubna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. dubna 2021
Naposledy ověřeno
1. dubna 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 20210330BMI
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
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