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National Register Studies in Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT03567538
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Ulrik Sartipy, MD, PhD, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment
Lung Cancer Pulmonary Metastasis Surgery Procedure: Thoracic surgery

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:

  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.

Study Type : Observational
Actual Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: National Register Studies in Thoracic Surgery
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 15 years ]
    Death from any cause


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    Complications related to surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All adult patients who underwent thoracic surgery in Sweden during the study period
Criteria

Inclusion Criteria:

All adult patients who underwent thoracic surgery in Sweden during the study period

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567538


Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
Principal Investigator: Ulrik Sartipy, MD, PhD Karolinska University Hospital/Karolinska Institutet

Responsible Party: Ulrik Sartipy, MD, PhD, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03567538     History of Changes
Other Study ID Numbers: NatRegThx
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ulrik Sartipy, MD, PhD, Karolinska University Hospital:
Thoracic surgery
Lung surgery
Epidemiologic Methods