- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877043
Study of the Quality of Lung Resection (ResPul)
August 19, 2016 updated by: Centre Hospitalier Universitaire Dijon
Measurement of the Quality: Application to Lung Resection for Cancer Using a National PMSI Database
In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan.
One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer.
Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care.
To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality.
This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013.
It will be limited to hospitalization for lung resection.
The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
72000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dijon, France, 21079
- Chu Dijon Bourgogne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing lung resection
Description
Inclusion Criteria:
Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with:
- A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer
- And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy).
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients undergoing lung resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of deaths during hospitalization
Time Frame: 9 years
|
number of death during hospitalization for pulmonary resection from 2005 to 2013
|
9 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 19, 2016
First Posted (Estimate)
August 24, 2016
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 19, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAGES AOI 2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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