ThoracicNCT06483464
Validation of ACS NSQIP Risk Calculator for Predicting Complications After Thoracic Surgery at University Hospital Basel
An observational study of Thoracic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This single-center retrospective research project aims to evaluate whether and what is the significance of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk score in thoracic surgery at the University Hospital Basel. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Thoracic
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2021to 31 Aug 2023
- 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 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: A consecutive series of cases of patients who signed the general research consent of the University Hospital Basel and have undergone a thoracic intervention at the University Hospital Basel between 01.05.2021 to 01.03.2022.
Who may be able to join
- Patients with signed general research consent
- Patients who underwent surgery in our department for the period from 01.05.2021 to 01.03.2022
- Patients with preoperative ACS NSQIP Risk score
Who cannot join
- Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Thoracic Surgery, University Hospital of Basel
Basel, 4031
About this study
Official title: Validation of the ACS NSQIP Risk Calculator as Predictive Tool for Complications After Thoracic Surgery in Consecutive Series of Patients Operated at the Department of Thoracic Surgery University Hospital Basel
This single-center retrospective research project aims to evaluate whether and what is the significance of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk score in thoracic surgery at the University Hospital Basel.
Read the detailed description
Advances in medical and surgical therapies have enabled treatment for polymorbid patients, who often have multiple chronic conditions. This has increased the need to accurately assess the risks of postoperative complications and mortality. Due to their complex health status, these patients are more susceptible to adverse outcomes following surgery, necessitating precise risk prediction to guide clinical decision-making and optimize outcomes.
This single-center retrospective research project compares the preoperative risk assessments by the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator with actual complications (graded according to the Clavien-Dindo classification) observed in patients who underwent thoracic surgery at the University Hospital Basel between May 1, 2021, and March 1, 2022.
The ACS NSQIP risk calculator, a web-based tool, uses 21 preoperative risk factors to predict 13 perioperative outcomes, including serious complications, infections, and mortality. By evaluating these predictions against real patient outcomes, this research project aims to validate the calculator's accuracy specifically in the context of thoracic surgery.
The results of this research project could optimize patient care by better identifying high-risk patients and improving preoperative preparation.
- Conditions
- Thoracic
- Keywords
- Thoracic surgery, Predicting complications, National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Suitability of the ACS NSQIP risk calculator
To evaluate the suitability of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator for thoracic surgery, the ACS NSQIP risk score is compared to actual complications.
ACS NSQIP risk score is a tool used to predict the likelihood of postoperative complications and mortality in surgical patients. It is calculated based on a range of preoperative variables, including patient demographics, comorbidities, and the type of surgery being performed. The values of the ACS NSQIP risk score can range from 0 to 100, with higher scores indicating a higher risk of complications and a worse expected outcome.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 May 2021
- Primary completion1 Mar 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolay Tsvetkov, MD, Principal investigator, Department of Thoracic Surgery, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483464
- Sponsor's protocol ID
- 2022-02163; kt24Tsvetkov
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the ACS NSQIP Risk Calculator as Predictive Tool for Complications After Thoracic Surgery in Consecutive Series of Patients Operated at the Department of Thoracic Surgery University Hospital Basel
- ClinicalTrials.gov ID
- NCT06483464
- Acronym / sponsor ID
- 2022-02163; kt24Tsvetkov
- Conditions
- Thoracic
- Keywords
- Thoracic surgery, Predicting complications, National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Jul 2024 (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.
This single-center retrospective research project aims to evaluate whether and what is the significance of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk score in thoracic surgery at the University Hospital Basel.
Detailed description
Advances in medical and surgical therapies have enabled treatment for polymorbid patients, who often have multiple chronic conditions. This has increased the need to accurately assess the risks of postoperative complications and mortality. Due to their complex health status, these patients are more susceptible to adverse outcomes following surgery, necessitating precise risk prediction to guide clinical decision-making and optimize outcomes.
This single-center retrospective research project compares the preoperative risk assessments by the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator with actual complications (graded according to the Clavien-Dindo classification) observed in patients who underwent thoracic surgery at the University Hospital Basel between May 1, 2021, and March 1, 2022.
The ACS NSQIP risk calculator, a web-based tool, uses 21 preoperative risk factors to predict 13 perioperative outcomes, including serious complications, infections, and mortality. By evaluating these predictions against real patient outcomes, this research project aims to validate the calculator's accuracy specifically in the context of thoracic surgery.
The results of this research project could optimize patient care by better identifying high-risk patients and improving preoperative preparation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A consecutive series of cases of patients who signed the general research consent of the University Hospital Basel and have undergone a thoracic intervention at the University Hospital Basel between 01.05.2021 to 01.03.2022.
Key inclusion criteria (3 listed)
- Patients with signed general research consent
- Patients who underwent surgery in our department for the period from 01.05.2021 to 01.03.2022
- Patients with preoperative ACS NSQIP Risk score
Key exclusion criteria (1 listed)
- Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Suitability of the ACS NSQIP risk calculator
Time frame: Up to 30 days after surgery
To evaluate the suitability of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator for thoracic surgery, the ACS NSQIP risk score is compared to actual complications. ACS NSQIP risk score is a tool used to predict the likelihood of postoperative complications and mortality in surgical patients. It is calculated based on a range of preoperative variables, including patient demographics, comorbidities, and the type of surgery being performed. The values of the ACS NSQIP risk score can range from 0 to 100, with higher scores indicating a higher risk of complications and a worse expected outcome.
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 3 Jul 2024.
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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.
Nikolay Tsvetkov, MD principal investigator
Department of Thoracic Surgery, University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 1 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Suitability of the ACS NSQIP risk calculator (time frame: Up to 30 days after surgery). 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 3 Jul 2024.