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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04989881
Enrollment
100
Registered
2021-08-04
Start date
2021-09-15
Completion date
2025-06-30
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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 .

Interventions

DEVICEda Vinci Simulator

Single training session

DEVICELaparascopic training box

Single training session

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Medical student at the University of Geneva

Exclusion criteria

* Previous laparoscopic experience * Stereoblindness

Design outcomes

Primary

MeasureTime frameDescription
FLS score post-training sessionUp 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

MeasureTime frameDescription
Times needed to perform training exercisesUp to 1 hour after the beginning of the training sessionTime required to perform the training exercises will be measured in both groups (dry-lab laparoscopic box and da Vinci skills simulator)

Countries

Switzerland

Contacts

Primary ContactPouya Iranmanesh, MD
pouya.iranmanesh@hcuge.ch+41795533205
Backup ContactKiana Shahinfar, MS
kiana.shahinfar@etu.unige.ch+41799192285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026