Comparison of da Vinci Simulator vs LapSim Simulator

Laparoscopy Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03079908
• Other study ID #: Simulator study
• Status: Withdrawn
• Phase: N/A
• First received: February 23, 2017
• Last updated: March 11, 2018
• Start date: August 15, 2017
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopy Training
• Robotic Surgery Training

Intervention

Other:
• da Vinci Skills Simulator®
Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation
• LapSim®
Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation
• Dry lab box laparoscopic training
No initial simulator training. Dry lab box laparoscopic Training only.

Locations

Country	Name	City	State
Switzerland	Luzern Kantonsspital Luzern	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)