Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery

Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study

The goal of this observational study is to assess the effect of functional status on bariatric surgical thirty-day outcomes. The main questions it aims to answer are:

• Is functional status associated with higher incidence of 30-day unplanned resource utilization?
• Is functional status associated with higher incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program

Study Overview

• Status: Completed
• Conditions: Frailty; Perioperative/Postoperative Complications; Dependence
• Intervention / Treatment: Procedure: Bariatric surgery; Drug: General anesthetic; Device: Indeterminate

• Study Type: Observational
• Enrollment (Actual): 65627

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Elective bariatric surgical patients, ACS-NSQIP 2015-2019

Description

Inclusion Criteria:

• Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847
• Elective, non-emergent cases
• "General surgery" surgical specialty
• "General anesthesia" anesthetic technique

Exclusion Criteria:

• Documented concurrent or other procedures
• Patients admitted to the hospital for greater than one day preceding surgery
• Acute kidney injury (preoperative)
• End-stage renal disease (preoperative)
• Metastatic disease (preoperative)
• Wound infection (preoperative)
• Sepsis (preoperative)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dependent functional status; 223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."	Procedure: Bariatric surgery; Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847.; Drug: General anesthetic; Cases were required to have a documented "general anesthesia" anesthetic technique. Administered drugs were otherwise indeterminate under the current study design (observational study of a deidentified database).; Device: Indeterminate; Devices were indeterminate under the current study design (observational study of a deidentified database).
Independent functional status; 65404 patients; "independent" for those documented as such.	Procedure: Bariatric surgery; Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847.; Drug: General anesthetic; Cases were required to have a documented "general anesthesia" anesthetic technique. Administered drugs were otherwise indeterminate under the current study design (observational study of a deidentified database).; Device: Indeterminate; Devices were indeterminate under the current study design (observational study of a deidentified database).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned resource utilization (composite)	A composite binary outcome comprising unplanned readmission, return to the operating room, or prolonged (≥ 30 day) length of stay.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	30 days
Composite organ system complications	Cardiac complications included cardiac arrest and myocardial infarction. The only neurologic complication that was captured was stroke/cerebrovascular accident. Respiratory complications included reintubation, prolonged ventilatory wean, and pneumonia. Hematologic/infectious complications included superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, wound dehiscence, bleeding, sepsis, septic shock, deep venous thrombosis, and pulmonary embolism. Renal complications included progressive renal insufficiency and acute kidney injury.	30 days

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, General
• Other Study ID Numbers: HSRZOKZZ2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No