EducationNCT01371136
Developing a Curriculum to Teach Laparoscopic Colorectal Surgery
A study testing curricular training in people with Education and Simulation, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Education, Simulation, Technical Skills Training
- What is being tested?
- curricular training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to May 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- resident in general surgery
- post graduate year (PGY) 2 or higher
- performed less than 10 laparoscopic colorectal procedures independently
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training. The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial. The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient. The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.
- Conditions
- Education, Simulation, Technical Skills Training, Laparoscopy
- Being tested
- curricular training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curricular trainingProcedure or surgery
Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.
| Study group | Role | What they receive |
|---|---|---|
| Curricular Trained | Experimental | Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver. Receives: Procedure: curricular training |
| conventional residency training | No intervention | These residents proceed through surgical residency training as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in operating room performance between intervention and control group
Surgical residents participating in the study will perform a laparoscopic right colectomy in the operating room. The procedure will be video-recorded through the laparoscopic camera. The videos will be given to a blinded expert in video assessment who will assess the technical proficiency of the resident using a validated global rating scale.
Measured: 5 months from intervention
Secondary outcomes (2)
Difference in cognitive knowledge between intervention and control group
Residents in both groups will complete a multiple choice test designed to assess the amount of cognitive knowledge they have relating to the technical steps of performing laparoscopic colorectal surgery
Measured: 5 months from the intervention
Difference in technical performance on the virtual reality simulator between intervention and control group residents
Study participants will complete the easy level of the virtual reality training portion of the curriculum
Measured: 5 months from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EducationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal College of Physicians and Surgeons of Canada
- Responsible party
- Principal investigator, Teodor Grantcharov, Unity Health Toronto
- Investigators
- Teodor P Grantcharov, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371136
- Sponsor's protocol ID
- SMH10-059
- Status last verified
- Nov 2015
- First submitted
- 8 Jun 2011
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Palter VN, Grantcharov TP. Development and validation of a comprehensive curriculum to teach an advanced minimally invasive procedure: a randomized controlled trial. Ann Surg. 2012 Jul;256(1):25-32. doi: 10.1097/SLA.0b013e318258f5aa.
PubMed 22664557
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Curriculum to Teach Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01371136
- Acronym / sponsor ID
- SMH10-059
- Conditions
- Education, Simulation, Technical Skills Training, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal College of Physicians and Surgeons of Canada
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Jun 2011 (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.
Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training. The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial. The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient. The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curricular Trained | Experimental | Procedure: curricular trainingResidents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver. |
| conventional residency training | No intervention | –These residents proceed through surgical residency training as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- resident in general surgery
- post graduate year (PGY) 2 or higher
- performed less than 10 laparoscopic colorectal procedures independently
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| curricular trainingResidents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver. | Procedure or surgery | Curricular Trained |
Primary outcome
Difference in operating room performance between intervention and control group
Time frame: 5 months from intervention
Surgical residents participating in the study will perform a laparoscopic right colectomy in the operating room. The procedure will be video-recorded through the laparoscopic camera. The videos will be given to a blinded expert in video assessment who will assess the technical proficiency of the resident using a validated global rating scale.
2 secondary outcomes
Difference in cognitive knowledge between intervention and control group
Time frame: 5 months from the intervention
Difference in technical performance on the virtual reality simulator between intervention and control group residents
Time frame: 5 months from intervention
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 17 Nov 2015.
- Derived from this study: PubMed 22664557Palter VN, Grantcharov TP. Development and validation of a comprehensive curriculum to teach an advanced minimally invasive procedure: a randomized controlled trial. Ann Surg. 2012 Jul;256(1):25-32. doi: 10.1097/SLA.0b013e318258f5aa.
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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
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curricular training in people with Education and Simulation, 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 3 inclusion and 0 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 17 Nov 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?
Difference in operating room performance between intervention and control group (time frame: 5 months from intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371136, which also lists 1 linked publication.
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 17 Nov 2015.