Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery
1 other identifier
observational
65,627
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedJune 26, 2023
June 1, 2023
5 years
June 5, 2023
June 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Composite organ system complications
30 days
Mortality
30 days
Study Arms (2)
Dependent functional status
223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."
Independent functional status
65404 patients; "independent" for those documented as such.
Interventions
Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847.
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).
Devices were indeterminate under the current study design (observational study of a deidentified database).
Eligibility Criteria
Elective bariatric surgical patients, ACS-NSQIP 2015-2019
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 26, 2023
Study Start
January 1, 2015
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
June 26, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
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.