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Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures (BMIORTHO)

1. april 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

76189

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Libanon
      • Beirut, Libanon, 11-236
        • American University of Beirut Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Representative of the population from ACS-NSQIP

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
underweight
patients who underwent one of the 25 common orthopaedic surgeries and have a body mass index (BMI) of <18.5kg/m2
Procedure: Orthopaedic surgery
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).
normal-weight
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 18.5kg/m2 and 24.9kg/m2
Procedure: Orthopaedic surgery
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).
overweight
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 25kg/m2 and 29.9kg/m2
Procedure: Orthopaedic surgery
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).
mildly obese
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI between 30kg/m2 and 34.9kg/m2
Procedure: Orthopaedic surgery
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).
moderately-to-severely obese
patients who underwent one of the 25 common orthopaedic surgeries and have a BMI ≥35kg/m2
Procedure: Orthopaedic surgery
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite morbidity
Tidsramme: 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.
within the 30 days following the surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mortality
Tidsramme: 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
wound
Tidsramme: 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
within the 30 days following the surgery
cardiac
Tidsramme: within the 30 days following the surgery
specific morbidity of cardiac complication for each BMI group as compared to normal-weight group
within the 30 days following the surgery
respiratory
Tidsramme: within the 30 days following the surgery
odds ratio of specific morbidity of respiratory complication
within the 30 days following the surgery
urinary
Tidsramme: 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
within the 30 days following the surgery
neurological
Tidsramme: 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
within the 30 days following the surgery
thromboembolism
Tidsramme: within the 30 days following the surgery
odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group
within the 30 days following the surgery
sepsis
Tidsramme: within the 30 days following the surgery
odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group
within the 30 days following the surgery
bleeding
Tidsramme: within the 30 days following the surgery
odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group
within the 30 days following the surgery
Re-op
Tidsramme: within the 30 days following the surgery
odds ratio of need for re-admission/re-operation for each BMI group as compared to normal-weight group
within the 30 days following the surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

American University of Beirut Medical Center

Efterforskere

  • Ledende efterforsker: Muhyeddine Al-Taki, American University of Beirut Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2012

Primær færdiggørelse (Faktiske)

31. december 2015

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

30. marts 2021

Først indsendt, der opfyldte QC-kriterier

30. marts 2021

Først opslået (Faktiske)

1. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 20210330BMI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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