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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917691
• Other study ID #: HSRZOKZZ2
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Dependence
• Frailty
• Perioperative/Postoperative Complications
• Postoperative Complications

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