Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures

Obesity Clinical Trial

— BMIORTHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827888
• Other study ID #: 20210330BMI
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76189
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Orthopedic Procedures

Intervention

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).

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite morbidity	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
Secondary	mortality	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
Secondary	wound	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
Secondary	cardiac	specific morbidity of cardiac complication for each BMI group as compared to normal-weight group	within the 30 days following the surgery
Secondary	respiratory	odds ratio of specific morbidity of respiratory complication	within the 30 days following the surgery
Secondary	urinary	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
Secondary	neurological	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
Secondary	thromboembolism	odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group	within the 30 days following the surgery
Secondary	sepsis	odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group	within the 30 days following the surgery
Secondary	bleeding	odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group	within the 30 days following the surgery
Secondary	Re-op	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