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Completed

NCT Number: NCT04827888

Effect of BMI on Postoperative Morbidities of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

American University of Beirut Medical Center

Beirut, 11-236, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orthopaedic surgery

Procedure

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).

Primary outcomes

  1. Composite morbidity

    Time frame: 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.

Secondary outcomes

  1. mortality

    Time frame: 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

  2. wound

    Time frame: 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

  3. cardiac

    Time frame: within the 30 days following the surgery

    specific morbidity of cardiac complication for each BMI group as compared to normal-weight group

  4. respiratory

    Time frame: within the 30 days following the surgery

    odds ratio of specific morbidity of respiratory complication

  5. urinary

    Time frame: 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

  6. neurological

    Time frame: 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

  7. thromboembolism

    Time frame: within the 30 days following the surgery

    odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group

  8. sepsis

    Time frame: within the 30 days following the surgery

    odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group

  9. bleeding

    Time frame: within the 30 days following the surgery

    odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group

  10. Re-op

    Time frame: 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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Acronym: BMIORTHO

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
Apr 1, 2021
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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