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Completed

NCT Number: NCT05917691

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

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

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Key information

Conditions

Dependence Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bariatric surgery

Procedure

Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847.

General anesthetic

Drug

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).

Indeterminate

Device

Devices were indeterminate under the current study design (observational study of a deidentified database).

Primary outcomes

  1. Unplanned resource utilization (composite)

    Time frame: 30 days

    A composite binary outcome comprising unplanned readmission, return to the operating room, or prolonged (≥ 30 day) length of stay.

Secondary outcomes

  1. Composite organ system complications

    Time frame: 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

    Time frame: 30 days

    Mortality

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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