NCT02877043

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
72,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 4, 2016

Last Update Submit

August 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of deaths during hospitalization

    number of death during hospitalization for pulmonary resection from 2005 to 2013

    9 years

Study Arms (1)

patients undergoing lung resection

Procedure: resection pulmonaire

Interventions

patients undergoing lung resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing lung resection

You may qualify if:

  • 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).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Carcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 24, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations