Clinical trial NCT04827888: Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures
Official title: The Effect Of BMI On Thirty-day Postoperative Morbidities And Mortality For The Most Common Orthopaedic Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Procedures
Obesity
Keywords: weight
orthopedic surgery
BMI
Post-Op Complication
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 76189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative of the population from ACS-NSQIP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite morbidity
timeFrame: within the 30 days following the surgery
Secondary outcomes:
measure: mortality
timeFrame: within the 30 days following the surgery
measure: wound
timeFrame: within the 30 days following the surgery
measure: cardiac
timeFrame: within the 30 days following the surgery
measure: respiratory
timeFrame: within the 30 days following the surgery
measure: urinary
timeFrame: within the 30 days following the surgery
measure: neurological
timeFrame: within the 30 days following the surgery
measure: thromboembolism
timeFrame: within the 30 days following the surgery
measure: sepsis
timeFrame: within the 30 days following the surgery
measure: bleeding
timeFrame: within the 30 days following the surgery
measure: Re-op
timeFrame: within the 30 days following the surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Muhyeddine Al-Taki
role: PRINCIPAL_INVESTIGATOR
References: