Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

Surgery Clinical Trial

Official title:

Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989881
• Other study ID #: University of Geneva
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Geneva
• Contact: Pouya Iranmanesh, MD
• Phone: +41795533205
• Email: pouya.iranmanesh[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.

Description:

This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Medical student at the University of Geneva

Exclusion Criteria:

• Previous laparoscopic experience

• Stereoblindness

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• da Vinci Simulator
Single training session
• Laparascopic training box
Single training session

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLS score post-training session	This score is a composite outcome combining the time needed to finish the exercises and the proficiency in performing them (number of dropped objects, lack of movements precision, exercises rules violations, etc.). The score will go from 0 (worst score) to 800 (best score), with a passing score of 356.	Up to 1 hour after the beginning of the exam session.
Secondary	Times needed to perform training exercises	Time required to perform the training exercises will be measured in both groups (dry-lab laparoscopic box and da Vinci skills simulator)	Up to 1 hour after the beginning of the training session