Trends in Volume-Outcome Relationship in Surgery (TREVORS)

June 16, 2017 updated by: Hospices Civils de Lyon

Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

759518

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

  • France
      • Lyon, France, 69002
        • Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients operated in French public and private hospitals from January 2010 to December 2014

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inpatient mortality
Time Frame: Within 30 days of surgical procedure
Within 30 days of surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation occurence
Time Frame: Within 30 days of surgical procedure
Within 30 days of surgical procedure
Occurence of intensive or critical care unit stay
Time Frame: Within 30 days of surgical procedure
Within 30 days of surgical procedure
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
Within 30 days of surgical procedure
Occurence of unplanned hospital readmission
Time Frame: Within 30 days of hospital discharge related to index stay
Within 30 days of hospital discharge related to index stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Antoine DUCLOS, MD, PhD, Hospices civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 19, 2017

Last Update Submitted That Met QC Criteria

June 16, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL16_0097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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