NCT01137305

Brief Summary

Background and hypothesis: Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Thus to hypothesize soft skills predicting surgical performance in a VR- setting. Method: A prospective randomized controlled single center educational trial was carried out to evaluate the impact of structured VR- training and defined soft skills such as self- efficacy, stress- coping and motivation on VR- performance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
Last Updated

June 17, 2010

Status Verified

June 1, 2010

Enrollment Period

7 months

First QC Date

June 2, 2010

Last Update Submit

June 16, 2010

Conditions

Keywords

Virtual realitysurgical trainingHealth Care [N]

Outcome Measures

Primary Outcomes (1)

  • VR- performance after training

    Outcome measurement comprised defined parameters of VR- performance including "time to complete task", economy of instrument motion" and "tissue damage" within the most complex module "diathermy cutting" as primary endpoint.

    Three months

Interventions

Prospective randomization if 50 subjects to either three months of structured VR- training or no training; basic VR- skills assessment and a serial assessment of defined soft skills: self- efficacy, stress- coping and motivation prior to randomization; basic VR- skills measured within seven modules of the VR- simulator LapSim®: "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting" in different levels of difficulty- medium and hard referring to "time to complete task", "economy of instrument motion" and "tissue damage"; intervention group: sessions of 45 minutes each twice a week for three months; control group: no training

Also known as: Educational trial within surgical trainees

Eligibility Criteria

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

You may qualify if:

  • surgical residency not exceeding the first year of surgical training
  • limited experience in MIS (camera navigation in laparoscopic cholecystectomies only)
  • informed consent to study procedures and publication of anonymized data

You may not qualify if:

  • surgical residency exceeding the first year of surgical training
  • experience in MIS exceeding camera navigation in laparoscopic cholecystectomies
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Iyad Hassan, MD

    Department of Visceral-, Thoracic- and Vascular Surgery, Philipps- University Marburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 4, 2010

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

June 17, 2010

Record last verified: 2010-06