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The FEEDBACK Trial, a Randomized Controlled Trial

NCT ID: NCT01497782

Last Updated: 2011-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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

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Laparoscopic Proficiency

Keywords

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virtual reality, simulator, feedback, laparoscopy, training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Instructor feedback

Intervention Type OTHER

Intervention 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

Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jeanett Oestergaard

MD, PhD fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeanett Oestergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark

Locations

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Rigshospitalet, University Hospital of Copenhagen

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 19443914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16823649 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25139606 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23295321 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22373062 (View on PubMed)

Other Identifiers

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H-3-2010-082 FEEDBACK

Identifier Type: -

Identifier Source: org_study_id