Comparison of da Vinci Simulator vs LapSim Simulator

Comparison of the da Vinci Skills Simulator and the LapSim Laparoscopy Simulator for Conventional Laparoscopic Skills Improvement: a Prospective, Randomized Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Laparoscopy Training; Robotic Surgery Training
• Intervention / Treatment: Other: da Vinci Skills Simulator®; Other: LapSim®; Other: Dry lab box laparoscopic training

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern, Switzerland, 6000
    • Luzern Kantonsspital Luzern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: da Vinci Skills Simulator®; Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation
Active Comparator: 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	Other: LapSim®; Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation
Placebo Comparator: Dry lab box laparoscopic training; Participants in this group will undergo dry lab box laparoscopic training only	Other: Dry lab box laparoscopic training; No initial simulator training. Dry lab box laparoscopic Training only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercises times	Time to realize each training exercise as well as the final evaluation exercise	Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objects drops	Number of time objects were unwillingly dropped during each training exercise as well as the final evaluation exercise	Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Objects out of view	Number of times one or both instruments or objects used for the exercises were out of the viewing field during each training exercise as well as the final evaluation exercise	Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Instruments collisions	Number of collisions between the different instruments used to perform each training exercise as well as the final evaluation exercise	Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)

Collaborators and Investigators

• Sponsor: Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital
• Investigators: Study Director: Andreas Scheiwiller, MD, Luzerner Kantonsspital Luzern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Training; Surgery; Virtual reality; Laparoscopy; Simulation; Robotic Surgery; Da Vinci
• Other Study ID Numbers: Simulator study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes