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

Status

Completed

Conditions

Intervention / Treatment

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

      • Lyon, France
        • 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 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
  • Charting system for outcomes feedback
  • Profiling of individual surgeon
  • Modules of improvement
No Intervention: Control arm
Surgeons randomly assigned to the control arm

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

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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