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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04532658
Other study ID # TOPSURGEONS_2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date January 2025

Study information

Verified date July 2022
Source Hospices Civils de Lyon
Contact Antoine Duclos
Phone 624302202
Email antoineduclos@yahoo.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events. Trends in surgical outcomes before and after the intervention will be compared between surgeons randomly assigned to the coaching program against non-exposed surgeons.


Recruitment information / eligibility

Status Recruiting
Enrollment 16000
Est. completion date January 2025
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - All adults needing a surgery who are operated by one of the participating surgeons Exclusion Criteria: - Age < 18 years old - Absence of surgical procedure - Palliative care - Organ transplantation - Refusal for personal data sharing

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coaching program
Charting system for outcomes feedback Profiling of individual surgeon Modules of improvement

Locations

Country Name City State
France 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 Occurrence of major adverse event During surgery or within 30 days after the operation
Primary Occurrence of death During surgery or within 30 days after the operation
Primary Occurrence of unplanned stay in critical/intensive care unit Within 30 days after the operation
Primary Occurrence of unplanned reoperation Within 30 days after the operation
Primary Occurrence of intraoperative and postoperative complications During surgery or within 30 days after the operation
Primary : Occurrence of avoidable hospital readmission for complication Within 30 days after the operation
Primary Operative time From skin incision to wound closure
Primary Length of stay From hospital admission to discharge, within 30 days after operation
Primary Hospitalization costs Within 30 days after the operation
Primary Surgeon well-being Throughout the study, Through study completion, an average of 1 year
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