NCT02788331

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
759,518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

May 27, 2016

Last Update Submit

June 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inpatient mortality

    Within 30 days of surgical procedure

Secondary Outcomes (4)

  • Reoperation occurence

    Within 30 days of surgical procedure

  • Occurence of intensive or critical care unit stay

    Within 30 days of surgical procedure

  • Occurence of postoperative complication

    Within 30 days of surgical procedure

  • Occurence of unplanned hospital readmission

    Within 30 days of hospital discharge related to index stay

Study Arms (3)

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

Interventions

Hospitals with decreasing activityHospitals with increasing activityHospitals with stable activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Hospitalization \<24 hours
  • Absence of surgical procedure
  • Ambulatory care
  • Palliative care
  • Organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Lyon, 69002, France

Location

Related Publications (1)

  • Payet C, Polazzi S, Lifante JC, Cotte E, Grinberg D, Carty MJ, Sanchez S, Rabilloud M, Duclos A. Influence of trends in hospital volume over time on patient outcomes for high-risk surgery. BMC Health Serv Res. 2020 Apr 1;20(1):274. doi: 10.1186/s12913-020-05126-4.

Study Officials

  • Antoine DUCLOS, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 2, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations