Laparoscopic ProficiencyFeedbackNCT01497782
The FEEDBACK Trial, a Randomized Controlled Trial
A study testing Instructor feedback in people with Laparoscopic Proficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Proficiency
- What is being tested?
- Instructor feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jan 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical student at Copenhagen University with passed bachelor degree
- Signed informed consent
Who cannot join
- Prior experience with surgical virtual reality simulators
- > 3 independent laparoscopic procedures
- Not fluent in the Danish language
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, University Hospital of Copenhagen
Copenhagen, Copenhagen, 2100
About this study
Official title: Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial
With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator.
The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.
Read the detailed description
For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear. Throughout the last decade several studies have found a positive effect on the learning curve as well as improvement of basic psychomotor skills in the operating room after VR training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from simple basic skills training to full procedures such as a cholecystectomy or salpingectomy. Despite the now well-established advantages of VR simulators, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training in the surgical education. This is mainly due to lack of knowledge concerning the time and human resources/cost needed to train novice surgeons to an adequate level.
This randomized trial investigates whether instructor feedback is pivotal for the trainee when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor feedback consists of standardized feedback for ten minutes and with a maximum of three optional feedback sessions; the trainees (in the intervention group) decides them selves when they want a feedback session. The trainees in both the control group and the intervention group have to reach a predefined proficiency level on the VR simulator within 8 weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different learning approaches, e.g. a self-directed approach and an independent approach.
The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark. Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours annually)
- Conditions
- Laparoscopic Proficiency
- Being tested
- Instructor feedback
- Keywords
- virtual reality, simulator, feedback, laparoscopy, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructor feedbackOther
Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
| Study group | Role | What they receive |
|---|---|---|
| Instructor feedback | Experimental | Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. Receives: Other: Instructor feedback |
| No instructor feedback | No intervention | Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitions
Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator
Measured: 8 weeks
Secondary outcomes (1)
Time
Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic ProficiencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Principal investigator, Jeanett Oestergaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jeanett Oestergaard, MD, Principal investigator, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497782
- Sponsor's protocol ID
- H-3-2010-082 FEEDBACK
- Acronym
- Feedback
- Status last verified
- Dec 2011
- First submitted
- 20 Dec 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802.
PubMed 19443914Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T, Ottesen B. Objective assessment of gynecologic laparoscopic skills using the LapSimGyn virtual reality simulator. Surg Endosc. 2006 Sep;20(9):1460-6. doi: 10.1007/s00464-005-0745-x. Epub 2006 Jul 3.
PubMed 16823649Bjerrum F, Maagaard M, Led Sorensen J, Rifbjerg Larsen C, Ringsted C, Winkel P, Ottesen B, Strandbygaard J. Effect of instructor feedback on skills retention after laparoscopic simulator training: follow-up of a randomized trial. J Surg Educ. 2015 Jan-Feb;72(1):53-60. doi: 10.1016/j.jsurg.2014.06.013. Epub 2014 Aug 16.
PubMed 25139606Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
PubMed 23295321Oestergaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Soerensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial. BMC Med Educ. 2012 Feb 28;12:7. doi: 10.1186/1472-6920-12-7.
PubMed 22373062
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01497782
- Acronym / sponsor ID
- Feedback / H-3-2010-082 FEEDBACK
- Conditions
- Laparoscopic Proficiency
- Keywords
- virtual reality, simulator, feedback, laparoscopy, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 22 Dec 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.
With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator.
The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.
Detailed description
For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear. Throughout the last decade several studies have found a positive effect on the learning curve as well as improvement of basic psychomotor skills in the operating room after VR training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from simple basic skills training to full procedures such as a cholecystectomy or salpingectomy. Despite the now well-established advantages of VR simulators, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training in the surgical education. This is mainly due to lack of knowledge concerning the time and human resources/cost needed to train novice surgeons to an adequate level.
This randomized trial investigates whether instructor feedback is pivotal for the trainee when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor feedback consists of standardized feedback for ten minutes and with a maximum of three optional feedback sessions; the trainees (in the intervention group) decides them selves when they want a feedback session. The trainees in both the control group and the intervention group have to reach a predefined proficiency level on the VR simulator within 8 weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different learning approaches, e.g. a self-directed approach and an independent approach.
The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark. Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours annually)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructor feedback | Experimental | Other: Instructor feedbackIntervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. |
| No instructor feedback | No intervention | –Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical student at Copenhagen University with passed bachelor degree
- Signed informed consent
Key exclusion criteria (3 listed)
- Prior experience with surgical virtual reality simulators
- > 3 independent laparoscopic procedures
- Not fluent in the Danish language
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 |
|---|---|---|
| Instructor feedbackIntervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. | Other | Instructor feedback |
Primary outcome
Repetitions
Time frame: 8 weeks
Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator
1 secondary outcome
Time
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
- Background: PubMed 19443914Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802.
- Background: PubMed 16823649Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T, Ottesen B. Objective assessment of gynecologic laparoscopic skills using the LapSimGyn virtual reality simulator. Surg Endosc. 2006 Sep;20(9):1460-6. doi: 10.1007/s00464-005-0745-x. Epub 2006 Jul 3.
- Derived from this study: PubMed 25139606Bjerrum F, Maagaard M, Led Sorensen J, Rifbjerg Larsen C, Ringsted C, Winkel P, Ottesen B, Strandbygaard J. Effect of instructor feedback on skills retention after laparoscopic simulator training: follow-up of a randomized trial. J Surg Educ. 2015 Jan-Feb;72(1):53-60. doi: 10.1016/j.jsurg.2014.06.013. Epub 2014 Aug 16.
- Derived from this study: PubMed 23295321Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
- Derived from this study: PubMed 22373062Oestergaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Soerensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial. BMC Med Educ. 2012 Feb 28;12:7. doi: 10.1186/1472-6920-12-7.
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.
Jeanett Oestergaard, MD principal investigator
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructor feedback in people with Laparoscopic Proficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2011. 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 Denmark. 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?
Results are not available in the source record.
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?
Repetitions (time frame: 8 weeks). 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 NCT01497782, which also lists 5 linked publications.
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 Dec 2011.