Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

Not Applicable

Recruiting

• Conditions: Surgery
• Interventions: Device: da Vinci Simulator; Device: Laparascopic training box

• Registration Number: NCT04989881
• Lead Sponsor: University Hospital, Geneva

Brief 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.

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 Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-04
• Study Start: 2021-09-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Medical student at the University of Geneva

Exclusion Criteria

• Previous laparoscopic experience
• Stereoblindness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Da Vinci Simulator	da Vinci Simulator	Participants will undergo a single session of training using the da Vinci Simulator
Laparascopic training box	Laparascopic training box	Participants will undergo a single session of training using a laparoscopic training box

Primary Outcome Measures

Name	Time	Method
FLS score post-training session	Up to 1 hour after the beginning of the exam 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.

Secondary Outcome Measures

Name	Time	Method
Times needed to perform training exercises	Up to 1 hour after the beginning of the training session	Time required to perform the training exercises will be measured in both groups (dry-lab laparoscopic box and da Vinci skills simulator)

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland