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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03567538
Other study ID # NatRegThx
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date January 2025

Study information

Verified date October 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.


Description:

The purpose of this research project is to study risks and outcomes in patients who underwent thoracic surgery, primarily for lung cancer. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish quality register for thoracic surgery (ThoR) and other national health-data registers maintained by the government agencies Statistics Sweden and the National Board of Health and Welfare. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers. Specifically, we aim: 1. To analyze the association between socioeconomic factors and prognosis in patients undergoing pulmonary resection for lung cancer. 2. To investigate the implementation of minimally invasive surgery for lung cancer in Sweden.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20000
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria: All adult patients who underwent thoracic surgery in Sweden during the study period Exclusion Criteria: -

Study Design


Intervention

Procedure:
Thoracic surgery
Thoracic surgery, pulmonary resection, minimally invasive thoracic surgery, video assisted thoracic surgery (VATS)

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska University Hospital Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Al-Ameri M, Bergman P, Franco-Cereceda A, Sartipy U. Video-assisted thoracoscopic versus open thoracotomy lobectomy: a Swedish nationwide cohort study. J Thorac Dis. 2018 Jun;10(6):3499-3506. doi: 10.21037/jtd.2018.05.177. Erratum In: J Thorac Dis. 2020 Apr;12(4):1645. — View Citation

Al-Ameri M, Persson M, Bergman P, Franco-Cereceda A, Sartipy U. Surgery for pulmonary metastases from colorectal cancer: survival and prognostic factors. J Thorac Dis. 2018 Jun;10(6):3372-3380. doi: 10.21037/jtd.2018.05.120. — View Citation

Jackson V, Al-Ameri M, Sartipy U. Weekday and Survival After Pulmonary Resections for Lung Cancer: A Swedish Nationwide Cohort Study. Chest. 2018 May;153(5):1284-1286. doi: 10.1016/j.chest.2018.03.022. No abstract available. — View Citation

Sachs E, Jackson V, Sartipy U. Household disposable income and long-term survival after pulmonary resections for lung cancer. Thorax. 2020 Sep;75(9):764-770. doi: 10.1136/thoraxjnl-2019-214321. Epub 2020 Jun 20. — View Citation

Sachs E, Sartipy U, Jackson V. Sex and Survival After Surgery for Lung Cancer: A Swedish Nationwide Cohort. Chest. 2021 May;159(5):2029-2039. doi: 10.1016/j.chest.2020.11.010. Epub 2020 Nov 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Death from any cause 15 years
Secondary Postoperative complications Complications related to surgery 30 days
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