Frailty Clinical Trial
Official title:
Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study
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 |
Verified date | June 2023 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
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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