EducationNCT01857180
Comprehensive Laparoscopic Curriculum for Medical Students
A study testing Curriculum in people with Education and Laparoscopic Surgery, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Education, Laparoscopic Surgery
- What is being tested?
- Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Aug 2012
- 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
- first and second year medical students
Who cannot join
- previous exposure to laparoscopy or laparoscopic simulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction of a Comprehensive Training Curriculum in Laparoscopic Surgery for Medical Students: a Randomized Trial.
Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Acknowledging this, several comprehensive curricula have been developed to teach basic skills as well as advanced laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to surgery no designated curricula have been developed to introduce medical students to the technique of laparoscopic surgery.
Participation in an introductory curriculum in laparoscopic surgery results in improved cognitive and technical performance compared to self-directed learning. The greater homogeneity and fewer dropouts amongst those in the curriculum group suggest that a structured curriculum is essential in ensuring standardization of clinically relevant training. An introductory curriculum for medical students should be delivered in a structured and standardized fashion prior to clinical exposure in order to maintain motivation and enhance learning.
- Conditions
- Education, Laparoscopic Surgery
- Being tested
- Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurriculumOther
| Study group | Role | What they receive |
|---|---|---|
| Curriculum | Experimental | Participants in the curriculum group took part in a structured, comprehensive curriculum consisting of a 1 hour didactic cognitive component, a 1 hour didactic non-technical (team-based skills) component, and 6 hours of structured technical skills practice in peg transfer, intracorporeal suture, and VR simulator tasks. Participants had the opportunity to ask questions and engage in discussion with experts after the didactic sessions, and received subjective feedback from circulating residents in addition to objective feedback in the technical skills tasks. Receives: Other: Curriculum |
| Self-directed | No intervention | Participants in the control (self-directed) group took part in 8 hours of self-directed learning with written materials for cognitive and non-technical skills components and unstructured surgical simulation practice of technical skills with only objective feedback from the simulator for the VR tasks or time for the peg transfer and intracorporeal suture tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Knowledge
Participants' basic laparoscopic knowledge was assessed regarding topics such as advantages and disadvantages, patient selection considerations, equipment, anesthesia, patient positioning, pneumoperitoneum, and post-op care. Assessment was by a multiple choice test.
Measured: 1 week
Team-based (non-technical) skills
Participants' attitudes towards team based skills, namely team structure, leadership, situational awareness, and communication were assessed by the Team-STEPPS Teamwork Attitudes Questionnaire (T-TAQ).
Measured: 1 week
Technical Skills
Participants' technical skills were assessed as they performed peg transfer, intracorporeal suture, and virtual reality simulator tasks (grasping, cutting, and clipping). Peg transfer and intracorporeal suture were assessed by time and errors, while VR tasks were assessed by the simulator's pre-set metrics.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857180
- Sponsor's protocol ID
- Med Student Lap Curriculum
- Status last verified
- Nov 2015
- First submitted
- 15 May 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Introduction of a Comprehensive Training Curriculum in Laparoscopic Surgery for Medical Students: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT01857180
- Acronym / sponsor ID
- Med Student Lap Curriculum
- Conditions
- Education, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 May 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.
Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Acknowledging this, several comprehensive curricula have been developed to teach basic skills as well as advanced laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to surgery no designated curricula have been developed to introduce medical students to the technique of laparoscopic surgery.
Participation in an introductory curriculum in laparoscopic surgery results in improved cognitive and technical performance compared to self-directed learning. The greater homogeneity and fewer dropouts amongst those in the curriculum group suggest that a structured curriculum is essential in ensuring standardization of clinically relevant training. An introductory curriculum for medical students should be delivered in a structured and standardized fashion prior to clinical exposure in order to maintain motivation and enhance learning.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curriculum | Experimental | Other: CurriculumParticipants in the curriculum group took part in a structured, comprehensive curriculum consisting of a 1 hour didactic cognitive component, a 1 hour didactic non-technical (team-based skills) component, and 6 hours of structured technical skills practice in peg transfer, intracorporeal suture, and VR simulator tasks. Participants had the opportunity to ask questions and engage in discussion with experts after the didactic sessions, and received subjective feedback from circulating residents in addition to objective feedback in the technical skills tasks. |
| Self-directed | No intervention | –Participants in the control (self-directed) group took part in 8 hours of self-directed learning with written materials for cognitive and non-technical skills components and unstructured surgical simulation practice of technical skills with only objective feedback from the simulator for the VR tasks or time for the peg transfer and intracorporeal suture tasks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- first and second year medical students
Key exclusion criteria (1 listed)
- previous exposure to laparoscopy or laparoscopic simulation
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 |
|---|---|---|
| Curriculum | Other | Curriculum |
Primary outcome
Cognitive Knowledge
Time frame: 1 week
Participants' basic laparoscopic knowledge was assessed regarding topics such as advantages and disadvantages, patient selection considerations, equipment, anesthesia, patient positioning, pneumoperitoneum, and post-op care. Assessment was by a multiple choice test.
Team-based (non-technical) skills
Time frame: 1 week
Participants' attitudes towards team based skills, namely team structure, leadership, situational awareness, and communication were assessed by the Team-STEPPS Teamwork Attitudes Questionnaire (T-TAQ).
Technical Skills
Time frame: 5 weeks
Participants' technical skills were assessed as they performed peg transfer, intracorporeal suture, and virtual reality simulator tasks (grasping, cutting, and clipping). Peg transfer and intracorporeal suture were assessed by time and errors, while VR tasks were assessed by the simulator's pre-set metrics.
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.
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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 Curriculum in people with Education and Laparoscopic 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 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?
Cognitive Knowledge (time frame: 1 week). The study lists 3 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 17 Nov 2015.