NCT04989881

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

April 7, 2021

Last Update Submit

May 15, 2024

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Times needed to perform training exercises

    Up to 1 hour after the beginning of the training session

Study Arms (2)

Da Vinci Simulator

EXPERIMENTAL

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

Device: da Vinci Simulator

Laparascopic training box

ACTIVE COMPARATOR

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

Device: Laparascopic training box

Interventions

da Vinci SimulatorDEVICE

Single training session

Da Vinci Simulator
Laparascopic training boxDEVICE

Single training session

Laparascopic training box

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student at the University of Geneva

You may not qualify if:

  • Previous laparoscopic experience
  • Stereoblindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

RECRUITING

Study Officials

  • Pouya Iranmanesh, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pouya Iranmanesh, MD

CONTACT

+41795533205pouya.iranmanesh@hcuge.ch

Kiana Shahinfar, MS

CONTACT

+41799192285kiana.shahinfar@etu.unige.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2021

First Posted

August 4, 2021

Study Start

September 15, 2021

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)