NCT01497782

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 22, 2011

Status Verified

December 1, 2011

Enrollment Period

6 months

First QC Date

December 20, 2011

Last Update Submit

December 21, 2011

Conditions

Laparoscopic Proficiency

Keywords

virtual reality, simulator, feedback, laparoscopy, training

Outcome Measures

Primary Outcomes (1)

  • Repetitions

    Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator

    8 weeks

Secondary Outcomes (1)

  • Time

    8 weeks

Study Arms (2)

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.

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.

Interventions

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.

Instructor feedback

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student at Copenhagen University with passed bachelor degree
  • Signed informed consent

You may not qualify if:

  • Prior experience with surgical virtual reality simulators
  • \> 3 independent laparoscopic procedures
  • Not fluent in the Danish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, University Hospital of Copenhagen

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 19443914BACKGROUND

  • Larsen 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.

    PMID: 16823649BACKGROUND

  • Bjerrum 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.

    PMID: 25139606DERIVED

  • Strandbygaard 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.

    PMID: 23295321DERIVED

  • Oestergaard 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.

    PMID: 22373062DERIVED

Study Officials

  • Jeanett Oestergaard, MD

    Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD fellow

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

December 22, 2011

Record last verified: 2011-12

Locations

DK(1)