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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05917691
Other study ID # HSRZOKZZ2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2019

Study information

Verified date June 2023
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 65627
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Mortality Mortality 30 days
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