- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532658
Evaluation of Coaching Impact on Surgical Outcomes (TopSurgeons)
July 8, 2025 updated by: Hospices Civils de Lyon
Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20791
Phase
- Not Applicable
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
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-
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Lyon, France
- Hospices Civils de Lyon
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-
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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
Surgeons randomly assigned to the intervention arm
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No Intervention: Control arm
Surgeons randomly assigned to the control arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of major adverse event
Time Frame: During surgery or within 30 days after the operation
|
During surgery or within 30 days after the operation
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Occurrence of death
Time Frame: During surgery or within 30 days after the operation
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During surgery or within 30 days after the operation
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Occurrence of unplanned stay in critical/intensive care unit
Time Frame: Within 30 days after the operation
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Within 30 days after the operation
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|
Occurrence of unplanned reoperation
Time Frame: Within 30 days after the operation
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Within 30 days after the operation
|
|
Occurrence of intraoperative and postoperative complications
Time Frame: During surgery or within 30 days after the operation
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During surgery or within 30 days after the operation
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|
: Occurrence of avoidable hospital readmission for complication
Time Frame: Within 30 days after the operation
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Within 30 days after the operation
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Operative time
Time Frame: From skin incision to wound closure
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From skin incision to wound closure
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Length of stay
Time Frame: From hospital admission to discharge, within 30 days after operation
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From hospital admission to discharge, within 30 days after operation
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Hospitalization costs
Time Frame: Within 30 days after the operation
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Within 30 days after the operation
|
|
Surgeon well-being
Time Frame: Throughout the study, Through study completion, an average of 1 year
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Throughout the study, Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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 (Actual)
February 1, 2019
Primary Completion (Actual)
January 31, 2024
Study Completion (Actual)
January 31, 2025
Study Registration Dates
First Submitted
August 20, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2025
Last Update Submitted That Met QC Criteria
July 8, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- TOPSURGEONS_2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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