Trends in Volume-Outcome Relationship in Surgery

Surgical Procedures Clinical Trial

— TREVORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788331
• Other study ID #: 69HCL16_0097
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: June 16, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759518
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Procedures

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient mortality		Within 30 days of surgical procedure
Secondary	Reoperation occurence		Within 30 days of surgical procedure
Secondary	Occurence of intensive or critical care unit stay		Within 30 days of surgical procedure
Secondary	Occurence of postoperative complication	Postoperative complication includes sepsis, pulmonary embolism or deep vein thrombosis and cardiac arrest	Within 30 days of surgical procedure
Secondary	Occurence of unplanned hospital readmission		Within 30 days of hospital discharge related to index stay