Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)
1 april 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
76189
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beirut, Libanon, 11-236
- American University of Beirut Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Representative of the population from ACS-NSQIP
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Composite morbidity
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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mortality
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Muhyeddine Al-Taki, American University of Beirut Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2012
Primaire voltooiing (Werkelijk)
31 december 2015
Studie voltooiing (Werkelijk)
31 december 2020
Studieregistratiedata
Eerst ingediend
30 maart 2021
Eerst ingediend dat voldeed aan de QC-criteria
30 maart 2021
Eerst geplaatst (Werkelijk)
1 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 april 2021
Laatste update ingediend die voldeed aan QC-criteria
1 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 20210330BMI
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Only the de-identified and coded data are available through the registry and we do not plan of sharing any individual data
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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