NCT06483464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 21, 2024

Last Update Submit

June 27, 2024

Conditions

Thoracic

Keywords

Thoracic surgeryPredicting complicationsNational Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP)

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery, University Hospital of Basel

Basel, 4031, Switzerland

Location

Study Officials

  • Nikolay Tsvetkov, MD

    Department of Thoracic Surgery, University Hospital of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 3, 2024

Study Start

May 1, 2021

Primary Completion

March 1, 2022

Study Completion

August 31, 2023

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

CH(1)