Comparison of da Vinci Simulator vs LapSim Simulator

NCT ID: NCT03079908

Last Updated: 2018-03-13

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-06-30

Brief Summary

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Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects

Detailed Description

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Conditions

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Laparoscopy Training Robotic Surgery Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Da Vinci Skills Simulator®

Participants in this group will undergo robotic virtual reality surgical simulator training (Da Vinci Mimics) and will subsequently be evaluated on a dry lab laparoscopic box

Group Type EXPERIMENTAL

da Vinci Skills Simulator®

Intervention Type OTHER

Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation

LapSim®

Participants in this group will undergo laparoscopic virtual reality surgical simulator Training (LapSim) and will subsequently be evaluated on a dry lab laparoscopic box

Group Type ACTIVE_COMPARATOR

LapSim®

Intervention Type OTHER

Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation

Dry lab box laparoscopic training

Participants in this group will undergo dry lab box laparoscopic training only

Group Type PLACEBO_COMPARATOR

Dry lab box laparoscopic training

Intervention Type OTHER

No initial simulator training. Dry lab box laparoscopic Training only.

Interventions

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da Vinci Skills Simulator®

Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation

Intervention Type OTHER

LapSim®

Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation

Intervention Type OTHER

Dry lab box laparoscopic training

No initial simulator training. Dry lab box laparoscopic Training only.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy medical students aged 20 to 30 years old

Exclusion Criteria

* No prior surgical, laparoscopic or robotic experience
* No previously known severe learning disability or mental deficiency
* No handicap limiting the usage of one or both upper limb(s)
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Pouya Iranmanesh

Oberarzt (Senior Resident), Dr. med (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Scheiwiller, MD

Role: STUDY_DIRECTOR

Luzerner Kantonsspital Luzern, Switzerland

Locations

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Luzern Kantonsspital Luzern

Lucerne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Simulator study

Identifier Type: -

Identifier Source: org_study_id

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