- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567538
National Register Studies in Thoracic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- To analyze the association between socioeconomic factors and prognosis in patients undergoing pulmonary resection for lung cancer.
- To investigate the implementation of minimally invasive surgery for lung cancer in Sweden.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 171 76
- Karolinska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All adult patients who underwent thoracic surgery in Sweden during the study period
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: 15 years
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Death from any cause
|
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: 30 days
|
Complications related to surgery
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ulrik Sartipy, MD, PhD, Karolinska University Hospital/Karolinska Institutet
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NatRegThx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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