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

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT05917691
Collaborator
(none)
65,627
60

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery
  • Drug: General anesthetic
  • Device: Indeterminate

Study Design

Study Type:
Observational
Actual Enrollment :
65627 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Dependent functional status

223 patients; "dependent" for those documented as "partially dependent" or "totally dependent."

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).

Independent functional status

65404 patients; "independent" for those documented as such.

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Mortality [30 days]

    Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhiyi Zuo, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier:
NCT05917691
Other Study ID Numbers:
  • HSRZOKZZ2
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023