DependenceNCT05917691
Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery
An observational study of Dependence and Perioperative/Postoperative Complications, run by University of Virginia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dependence, Perioperative/Postoperative Complications, Frailty
- What is being tested?
- Bariatric surgery, General anesthetic and Indeterminate
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 65,627 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elective bariatric surgical patients, ACS-NSQIP 2015-2019
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study
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
- Being tested
- Bariatric surgery, General anesthetic, Indeterminate
- Medical subject headings
- Postoperative Complications, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847.
General anestheticDrug
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).
IndeterminateDevice
Devices were indeterminate under the current study design (observational study of a deidentified database).
| Study group | Role | What they receive |
|---|---|---|
| Dependent functional status | 223 patients; "dependent" for those documented as "partially dependent" or "totally dependent." Receives: Procedure: Bariatric surgery; Drug: General anesthetic; Device: Indeterminate | |
| Independent functional status | 65404 patients; "independent" for those documented as such. Receives: Procedure: Bariatric surgery; Drug: General anesthetic; Device: Indeterminate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned resource utilization (composite)
A composite binary outcome comprising unplanned readmission, return to the operating room, or prolonged (≥ 30 day) length of stay.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 30 days
Mortality
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DependenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65,627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Zuo, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917691
- Sponsor's protocol ID
- HSRZOKZZ2
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study
- ClinicalTrials.gov ID
- NCT05917691
- Acronym / sponsor ID
- HSRZOKZZ2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65,627 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dependent functional status | – | Procedure: Bariatric surgery, Drug: General anesthetic, Device: Indeterminate223 patients; "dependent" for those documented as "partially dependent" or "totally dependent." |
| Independent functional status | – | Procedure: Bariatric surgery, Drug: General anesthetic, Device: Indeterminate65404 patients; "independent" for those documented as such. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elective bariatric surgical patients, ACS-NSQIP 2015-2019
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryCurrent Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847. | Procedure or surgery | Dependent functional status, Independent functional status |
| General anestheticCases 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). | Drug | Dependent functional status, Independent functional status |
| IndeterminateDevices were indeterminate under the current study design (observational study of a deidentified database). | Device | Dependent functional status, Independent functional status |
Primary outcome
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.
2 secondary outcomes
Composite organ system complications
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Yes. American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dependence and Perioperative/Postoperative Complications, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned resource utilization (composite) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.