Surgical EducationNCT01560494
Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery
A study testing STAC curriculum in people with Surgical Education, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Education
- What is being tested?
- STAC curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Jul 2010
- 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
- post graduate year 1 and 2 general surgical residents
- completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study
This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.
Read the detailed description
The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.
- Conditions
- Surgical Education
- Being tested
- STAC curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAC curriculumOther
The STAC curriculum consists of theoretical preparation, case-based learning, proficiency-based virtual reality training, laparoscopic box training, and operating room participation.
| Study group | Role | What they receive |
|---|---|---|
| STAC curriculum | Experimental | Not described Receives: Other: STAC curriculum |
| Conventional Curriculum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical skills
Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS)
Measured: 6 months
Secondary outcomes (1)
cognitive knowledge
Study participants will complete a multiple choice quiz designed to assess congitive knowledge relating to performing laparoscpoic cholecystectomy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2010
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 Surgical EducationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teodor Grantcharov, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560494
- Sponsor's protocol ID
- STAC
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Palter VN, Orzech N, Reznick RK, Grantcharov TP. Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial. Ann Surg. 2013 Feb;257(2):224-30. doi: 10.1097/SLA.0b013e31827051cd.
PubMed 23013806
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01560494
- Acronym / sponsor ID
- STAC
- Conditions
- Surgical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Mar 2012 (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.
This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.
Detailed description
The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAC curriculum | Experimental | Other: STAC curriculum |
| Conventional Curriculum | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- post graduate year 1 and 2 general surgical residents
- completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon
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 |
|---|---|---|
| STAC curriculumThe STAC curriculum consists of theoretical preparation, case-based learning, proficiency-based virtual reality training, laparoscopic box training, and operating room participation. | Other | STAC curriculum |
Primary outcome
Technical skills
Time frame: 6 months
Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS)
1 secondary outcome
cognitive knowledge
Time frame: 6 months
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 22 Mar 2012.
- Derived from this study: PubMed 23013806Palter VN, Orzech N, Reznick RK, Grantcharov TP. Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial. Ann Surg. 2013 Feb;257(2):224-30. doi: 10.1097/SLA.0b013e31827051cd.
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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 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 STAC curriculum in people with Surgical Education, 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 2 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 22 Mar 2012. 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?
Technical skills (time frame: 6 months). 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 NCT01560494, 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 22 Mar 2012.