SurgeryTopSurgeonsNCT04532658
Evaluation of Coaching Impact on Surgical Outcomes
A study testing Coaching program in people with Surgery, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery
- What is being tested?
- Coaching program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,791 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults needing a surgery who are operated by one of the participating surgeons
Who cannot join
- Age < 18 years old
- Absence of surgical procedure
- Palliative care
- Organ transplantation
- Refusal for personal data sharing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- Coaching program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching programBehavioural
- Charting system for outcomes feedback
- Profiling of individual surgeon
- Modules of improvement
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Surgeons randomly assigned to the intervention arm Receives: Behavioral: Coaching program |
| Control arm | No intervention | Surgeons randomly assigned to the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major adverse event
Measured: During surgery or within 30 days after the operation
Occurrence of death
Measured: During surgery or within 30 days after the operation
Occurrence of unplanned stay in critical/intensive care unit
Measured: Within 30 days after the operation
Occurrence of unplanned reoperation
Measured: Within 30 days after the operation
Occurrence of intraoperative and postoperative complications
Measured: During surgery or within 30 days after the operation
: Occurrence of avoidable hospital readmission for complication
Measured: Within 30 days after the operation
Operative time
Measured: From skin incision to wound closure
Length of stay
Measured: From hospital admission to discharge, within 30 days after operation
Hospitalization costs
Measured: Within 30 days after the operation
Surgeon well-being
Measured: Throughout the study, Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Feb 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,791 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532658
- Sponsor's protocol ID
- TOPSURGEONS_2020
- Acronym
- TopSurgeons
- Status last verified
- Jul 2025
- First submitted
- 20 Aug 2020
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program
- ClinicalTrials.gov ID
- NCT04532658
- Acronym / sponsor ID
- TopSurgeons / TOPSURGEONS_2020
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,791 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Coaching programSurgeons randomly assigned to the intervention arm |
| Control arm | No intervention | –Surgeons randomly assigned to the control arm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults needing a surgery who are operated by one of the participating surgeons
Key exclusion criteria (5 listed)
- Age < 18 years old
- Absence of surgical procedure
- Palliative care
- Organ transplantation
- Refusal for personal data sharing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching program* Charting system for outcomes feedback * Profiling of individual surgeon * Modules of improvement | Behavioural | Intervention arm |
Primary outcome
Occurrence of major adverse event
Time frame: During surgery or within 30 days after the operation
Occurrence of death
Time frame: 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
Occurrence of unplanned reoperation
Time frame: Within 30 days after the operation
Occurrence of intraoperative and postoperative complications
Time frame: During surgery or within 30 days after the operation
: Occurrence of avoidable hospital readmission for complication
Time frame: Within 30 days after the operation
Operative time
Time frame: From skin incision to wound closure
Length of stay
Time frame: From hospital admission to discharge, within 30 days after operation
Hospitalization costs
Time frame: Within 30 days after the operation
Surgeon well-being
Time frame: Throughout the study, Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching program in people with Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major adverse event (time frame: During surgery or within 30 days after the operation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.