Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: da Vinci Simulator; Device: Laparascopic training box

Detailed 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 .

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pouya Iranmanesh, MD; Phone Number: +41795533205; Email: pouya.iranmanesh@hcuge.ch
• Study Contact Backup: Name: Kiana Shahinfar, MS; Phone Number: +41799192285; Email: kiana.shahinfar@etu.unige.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Geneva University Hospitals
    • Contact: Pouya Iranmanesh, MD; Phone Number: +41795533205; Email: pouya.iranmanesh@hcuge.ch
    • Principal Investigator: Pouya Iranmanesh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medical student at the University of Geneva

Exclusion Criteria:

• Previous laparoscopic experience
• Stereoblindness

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Da Vinci Simulator; Participants will undergo a single session of training using the da Vinci Simulator	Device: da Vinci Simulator; Single training session
Active Comparator: Laparascopic training box; Participants will undergo a single session of training using a laparoscopic training box	Device: Laparascopic training box; Single training session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Pouya Iranmanesh, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: University of Geneva

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: No