Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

NCT ID: NCT04989881

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2025-06-30

Brief Summary

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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

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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 .

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Da Vinci Simulator

Participants will undergo a single session of training using the da Vinci Simulator

Group Type EXPERIMENTAL

da Vinci Simulator

Intervention Type DEVICE

Single training session

Laparascopic training box

Participants will undergo a single session of training using a laparoscopic training box

Group Type ACTIVE_COMPARATOR

Laparascopic training box

Intervention Type DEVICE

Single training session

Interventions

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da Vinci Simulator

Single training session

Intervention Type DEVICE

Laparascopic training box

Single training session

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medical student at the University of Geneva

Exclusion Criteria

* Previous laparoscopic experience
* Stereoblindness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Pouya Iranmanesh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pouya Iranmanesh, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Pouya Iranmanesh, MD

Role: CONTACT

+41795533205

Kiana Shahinfar, MS

Role: CONTACT

+41799192285

Facility Contacts

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Pouya Iranmanesh, MD

Role: primary

+41795533205

Other Identifiers

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University of Geneva

Identifier Type: -

Identifier Source: org_study_id

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