Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trends in Volume-Outcome Relationship in Surgery (TREVORS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788331
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the " practice makes perfect " dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.

Condition or disease Intervention/treatment
Surgical Procedures Other: No intervention

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 759518 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals
Study Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Hospitals with increasing activity
Hospitals experiencing an increase in the volume of surgical procedures over the study period
 Other: No intervention
Hospitals with decreasing activity
Hospitals experiencing a decrease in the volume of surgical procedures over the study period
 Other: No intervention
Hospitals with stable activity
Hospitals experiencing no change in the volume of surgical procedures over the study period
 Other: No intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Inpatient mortality [ Time Frame: Within 30 days of surgical procedure ]

Secondary Outcome Measures :
  1. Reoperation occurence [ Time Frame: Within 30 days of surgical procedure ]
  2. Occurence of intensive or critical care unit stay [ Time Frame: Within 30 days of surgical procedure ]
  3. Occurence of postoperative complication [ Time Frame: Within 30 days of surgical procedure ]
    Postoperative complication includes sepsis, pulmonary embolism or deep vein thrombosis and cardiac arrest

  4. Occurence of unplanned hospital readmission [ Time Frame: Within 30 days of hospital discharge related to index stay ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients operated in French public and private hospitals from January 2010 to December 2014
Criteria

Inclusion Criteria:

All adults hospitalized to have one of the following major surgery: resection of oeso-gastric, intestinal and pancreatic cancer, treatment of intra-abdominal aortic aneurysm, coronary artery bypass graft, endarterectomy, hip fracture prosthesis

Exclusion Criteria:

  • Hospitalization <24 hours
  • Absence of surgical procedure
  • Ambulatory care
  • Palliative care
  • Organ transplantation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02788331


Locations
Layout table for location information
France
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Antoine DUCLOS, MD, PhD Hospices Civils de Lyon
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02788331    
Other Study ID Numbers: 69HCL16_0097
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No