The FEEDBACK Trial, a Randomized Controlled Trial

Laparoscopic Proficiency Clinical Trial

— Feedback  

Official title:

Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01497782
• Other study ID #: H-3-2010-082 FEEDBACK
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 20, 2011
• Last updated: December 21, 2011
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 99
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Medical student at Copenhagen University with passed bachelor degree

• Signed informed consent

Exclusion Criteria:

• Prior experience with surgical virtual reality simulators

• > 3 independent laparoscopic procedures

• Not fluent in the Danish language

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Laparoscopic Proficiency

Intervention

Other:
• Instructor feedback
Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.

Locations

Country	Name	City	State
Denmark	Rigshospitalet, University Hospital of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sørensen 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. Epub 2006 Jul 3. — View Citation

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. Erratum in: BMJ. 2009;338. doi: 10.1136/bmj.b2074. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repetitions	Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator	8 weeks	No
Secondary	Time	Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator.	8 weeks	No