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

Completed

• Conditions: Dependence; Perioperative/Postoperative Complications; Frailty
• Interventions: Procedure: Bariatric surgery; Drug: General anesthetic; Device: Indeterminate

• Registration Number: NCT05917691
• Lead Sponsor: University of Virginia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65627

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dependent functional status	Bariatric surgery	223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."
Dependent functional status	General anesthetic	223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."
Dependent functional status	Indeterminate	223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."
Independent functional status	Bariatric surgery	65404 patients; "independent" for those documented as such.
Independent functional status	General anesthetic	65404 patients; "independent" for those documented as such.
Independent functional status	Indeterminate	65404 patients; "independent" for those documented as such.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Composite organ system complications	30 days	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.
Mortality	30 days	Mortality