Validation of ACS NSQIP Risk Calculator for Predicting Co... | NCT06483464

Studies
Validation of ACS NSQIP Risk Calculator for Predicting Complications After Thoracic Surgery at University Hospital Basel

NCT06483464

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Thoracic

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Jun 21, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolay Tsvetkov, MD	Department of Thoracic Surgery, University Hospital of Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Thoracic Surgery, University Hospital of Basel		Basel		4031	Switzerland