Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01497782
Other study ID # H-3-2010-082 FEEDBACK
Secondary ID
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:

Read more »
Read more »

Study Design

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


Related Conditions & MeSH terms


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