Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures

Completed

• Conditions: Obesity; Orthopedic Procedures
• Interventions: Procedure: Orthopaedic surgery

• Registration Number: NCT04827888
• Lead Sponsor: American University of Beirut Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Status Verified: 2021-04
• Study First Posted: 2021-04-01
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76189

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite morbidity	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 Outcome Measures

Name	Time	Method
mortality	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
wound	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
cardiac	within the 30 days following the surgery	specific morbidity of cardiac complication for each BMI group as compared to normal-weight group
bleeding	within the 30 days following the surgery	odds ratio of bleeding or transfusion need for each BMI group as compared to normal-weight group
respiratory	within the 30 days following the surgery	odds ratio of specific morbidity of respiratory complication
thromboembolism	within the 30 days following the surgery	odds ratio of specific morbidity of thromboembolism for each BMI group as compared to normal-weight group
neurological	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
Re-op	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
urinary	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
sepsis	within the 30 days following the surgery	odds ratio of specific morbidity of sepsis for each BMI group as compared to normal-weight group

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon