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Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator

NCT ID: NCT01615549

Last Updated: 2013-08-23

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.

Conditions

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Cholelithiasis Cholecystitis Cholecystolithiasis

Keywords

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Cholecystectomy Virtual reality device Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Free training

Group Type ACTIVE_COMPARATOR

Laparsocopic cholecystectomy

Intervention Type PROCEDURE

Perform laparsocopic cholecystectomy on a virtual reality devise

Proficiency-based training

Group Type EXPERIMENTAL

Laparsocopic cholecystectomy

Intervention Type PROCEDURE

Perform laparsocopic cholecystectomy on a virtual reality devise

Interventions

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Laparsocopic cholecystectomy

Perform laparsocopic cholecystectomy on a virtual reality devise

Intervention Type PROCEDURE

Other Intervention Names

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Key whole gall bladder surgery

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Specialist surgeons
* Performed more than five laparoscopic procedures
* Previous experience with a simulator
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin W von Websky, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgery

Dimitri A Raptis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgery

Pierre-Alain Clavien, MD, PhD

Role: STUDY_CHAIR

University Hospital, Zürich

Dieter Hahnloser, MD

Role: STUDY_DIRECTOR

University Hospital Zurich, Department of Surgery

Locations

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University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

University Hospital Zurich, Department of Surgery

Zurich, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

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Switzerland

Central Contacts

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Martin W von Websky, MD

Role: CONTACT

Email: [email protected]

Dimitri A Raptis, MD, MSc

Role: CONTACT

Phone: +41798820542

Email: [email protected]

Facility Contacts

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Oliver M Fisher, MD

Role: primary

Dimitri A Raptis, MD, MSc

Role: backup

References

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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.

Reference Type DERIVED
PMID: 23942532 (View on PubMed)

Other Identifiers

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SNSF 32003B-120722

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Simbionix 20120507

Identifier Type: -

Identifier Source: org_study_id