Surgical Technical SkillNCT01875679
Comprehensive Surgical Coaching
A study testing Comprehensive Surgical Coaching and Conventional Surgical Training in people with Surgical Technical Skill and Technical Errors in Surgery, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Technical Skill, Technical Errors in Surgery
- What is being tested?
- Comprehensive Surgical Coaching and Conventional Surgical Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Oct 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study
Who cannot join
- individuals with severe illnesses precluding performance in the OR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Coaching -Using Error Debriefing, Behavioral Modeling and Error Recognition to Enhance Surgical Skill
Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.
The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.
Read the detailed description
Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.
Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).
Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.
Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.
Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.
- Being tested
- Comprehensive Surgical Coaching, Conventional Surgical Training
- Keywords
- Surgical education, Deliberate practice, Debriefing, Behaviour modelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Surgical CoachingOther
Conventional Surgical TrainingOther
Surgical training as per participant's residency program
| Study group | Role | What they receive |
|---|---|---|
| Conventional residency training | Active comparator | This group will continue their regular surgical training without any specific intervention. Receives: Other: Conventional Surgical Training |
| Comprehensive Surgical Coaching (SCS) | Experimental | The participants will receive an analysis of the technical performance as observed on baseline recordings of the index procedure. Training needs will be identified and a personalized coaching concept will be designed. Coaching sessions will include video debriefing of the participant's performance (sample recordings will be submitted by the participant during the sessions) and video assisted behavioral modeling using examples of good and poor technical performance. Coaching will also target increasing awareness of weaknesses and potential pitfalls in surgical technical task execution (error recognition). Receives: Other: Comprehensive Surgical Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Technical Skill
Surgical skill measures as recorded on a procedure specific global rating scale, Objective Structured Assessment of Technical Skills (OSATS) and bariatric OSATS (BOSATS) scores and by tabulation of technical errors, Generic Error Rating Tool (GERT) observed during the index procedures.
Measured: After 8 weeks of participation
Secondary outcomes (1)
Learning curves
Development of skill and reduction of errors will be assessed in relation to number of procedures performed to obtain learning curves for each study group.
Surgical technical skill will be assessed by OSATS and BOSATS scales, errors will be recorded by GERT checklist
Measured: Throughout 8 weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Technical SkillStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teodor P Grantcharov, MD. PhD, Principal investigator, St. Michael's Hospital (Toronto, Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875679
- Sponsor's protocol ID
- CSC2013
- Status last verified
- May 2015
- First submitted
- 15 May 2013
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Coaching -Using Error Debriefing, Behavioral Modeling and Error Recognition to Enhance Surgical Skill
- ClinicalTrials.gov ID
- NCT01875679
- Acronym / sponsor ID
- CSC2013
- Keywords
- Surgical education, Deliberate practice, Debriefing, Behaviour modelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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.
Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.
The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.
Detailed description
Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.
Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).
Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.
Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.
Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional residency training | Active comparator | Other: Conventional Surgical TrainingThis group will continue their regular surgical training without any specific intervention. |
| Comprehensive Surgical Coaching (SCS) | Experimental | Other: Comprehensive Surgical CoachingThe participants will receive an analysis of the technical performance as observed on baseline recordings of the index procedure. Training needs will be identified and a personalized coaching concept will be designed. Coaching sessions will include video debriefing of the participant's performance (sample recordings will be submitted by the participant during the sessions) and video assisted behavioral modeling using examples of good and poor technical performance. Coaching will also target increasing awareness of weaknesses and potential pitfalls in surgical technical task execution (error recognition). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study
Key exclusion criteria (1 listed)
- individuals with severe illnesses precluding performance in the OR
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 |
|---|---|---|
| Comprehensive Surgical Coaching | Other | Comprehensive Surgical Coaching (SCS) |
| Conventional Surgical TrainingSurgical training as per participant's residency program | Other | Conventional residency training |
Primary outcome
Surgical Technical Skill
Time frame: After 8 weeks of participation
Surgical skill measures as recorded on a procedure specific global rating scale, Objective Structured Assessment of Technical Skills (OSATS) and bariatric OSATS (BOSATS) scores and by tabulation of technical errors, Generic Error Rating Tool (GERT) observed during the index procedures.
1 secondary outcome
Learning curves
Time frame: Throughout 8 weeks of participation
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 21 May 2015.
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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.
Teodor P Grantcharov, MD. PhD principal investigator
St. Michael's Hospital (Toronto, Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Surgical Coaching and Conventional Surgical Training in people with Surgical Technical Skill and Technical Errors in Surgery, run by Unity Health Toronto at 1 site in Canada.
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 1 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 21 May 2015. 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 Canada. 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?
Surgical Technical Skill (time frame: After 8 weeks of participation). 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 21 May 2015.