NCT01615549

Brief Summary

Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.

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
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2004

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

10.7 years

First QC Date

May 23, 2012

Last Update Submit

August 22, 2013

Conditions

CholelithiasisCholecystitisCholecystolithiasis

Keywords

CholecystectomyVirtual reality deviceTraining

Outcome Measures

Primary Outcomes (1)

  • Time to extract the gall bladder.

    The time to extract the gall bladder on a virtual simulator is typically 10 minutes. However this varies according to the settings of the difficulty chosen on the virtual reality software. This is a continuous variable measuring the duration for a trainee surgeon to extract the gall bladder (measured in seconds). The start point is the beginning of the exercise and the finishing point is once the gall bladder is completely resected (gall bladder mobilized and the cystic duct and artery dissected and ligated).

    10 minutes in average

Secondary Outcomes (3)

  • Serious intra-operative complications

    10 minutes in average

  • Safe cautery

    10 minutes in average

  • Total path length of right instrument

    10 minutes in average

Study Arms (2)

Free training

ACTIVE COMPARATOR
Procedure: Laparsocopic cholecystectomy

Proficiency-based training

EXPERIMENTAL
Procedure: Laparsocopic cholecystectomy

Interventions

Laparsocopic cholecystectomyPROCEDURE

Perform laparsocopic cholecystectomy on a virtual reality devise

Also known as: Key whole gall bladder surgery
Free trainingProficiency-based training

Eligibility Criteria

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

You may qualify if:

  • Surgical novices (trainees / residents)
  • Performed less than five laparoscopic procedures
  • No previous simulator experience

You may not qualify if:

  • Specialist surgeons
  • Performed more than five laparoscopic procedures
  • Previous experience with a simulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

University Hospital Zurich, Department of Surgery

Zurich, CH-8091, Switzerland

ACTIVE NOT RECRUITING

Related Publications (1)

  • von Websky MW, Raptis DA, Vitz M, Rosenthal R, Clavien PA, Hahnloser D. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial. World J Surg. 2013 Nov;37(11):2534-41. doi: 10.1007/s00268-013-2175-6.

    PMID: 23942532DERIVED

MeSH Terms

Conditions

CholelithiasisCholecystitisCholecystolithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Martin W von Websky, MD

    University Hospital Zurich, Department of Surgery

    PRINCIPAL INVESTIGATOR

  • Dimitri A Raptis, MD, MSc

    University Hospital Zurich, Department of Surgery

    PRINCIPAL INVESTIGATOR

  • Pierre-Alain Clavien, MD, PhD

    University Hospital, Zürich

    STUDY CHAIR

  • Dieter Hahnloser, MD

    University Hospital Zurich, Department of Surgery

    STUDY DIRECTOR

Central Study Contacts

Martin W von Websky, MD

CONTACT

martin@websky.de

Dimitri A Raptis, MD, MSc

CONTACT

+41798820542dimitri.raptis@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

June 8, 2012

Study Start

April 1, 2004

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

CH(2)