NCT02370407

Brief Summary

This is a randomized controlled trial that will randomize 40 surgical skill naive medical students to practice on a robotic simulator or laparoscopic simulator after first completing a baseline evaluation on both surgical simulation platforms. Medical students will be evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess transferability of skills between the surgical simulation platforms.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

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

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 28, 2017

Completed
Last Updated

August 28, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

November 25, 2014

Results QC Date

May 23, 2017

Last Update Submit

July 26, 2017

Conditions

Surgical Simulation Education

Keywords

surgical educationminimally invasive surgical procedureslaparoscopic simulationrobotic simulationmedical education

Outcome Measures

Primary Outcomes (4)

  • Time to Task Completion (Robotic Task)

    Primary outcome will be time to task completion (seconds) on the robotic task

    1 day of practice

  • Global Rating Scale Score on the Laparoscopic Task

    Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.

    Study duration

  • Global Rating Scale Score on the Robotic Task

    A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.

    Study duration

  • Time to Task Completion on the Laparoscopic Task

    Time to task completion (seconds) on the laparoscopic task

    1 day of practice

Secondary Outcomes (5)

  • Economy of Motion on the Robotic Task

    Study duration

  • Instrument Out of View

    through study completion

  • Instrument Collisions

    study duration

  • Time Spent Using Excessive Force

    study duration

  • Workspace Range

    study duration

Study Arms (2)

Laparoscopic simulator

EXPERIMENTAL

20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA).

Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)

Mimic da Vinci robotic simulator

EXPERIMENTAL

20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA).

Device: Mimic da Vinci robotic simulator

Interventions

a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)DEVICE

10 repetitions of practice on laparoscopic simulator.

Laparoscopic simulator
Mimic da Vinci robotic simulatorDEVICE

10 repetitions of practice on Mimic da Vinci robotic simulator.

Mimic da Vinci robotic simulator

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical students with no prior laparoscopic or robotic experience in clinical or practice setting

You may not qualify if:

  • Prior laparoscopic or robotic experience in clinical setting or in practice setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Orlando MS, Thomaier L, Abernethy MG, Chen CCG. Retention of laparoscopic and robotic skills among medical students: a randomized controlled trial. Surg Endosc. 2017 Aug;31(8):3306-3312. doi: 10.1007/s00464-016-5363-2. Epub 2017 Jan 11.

    PMID: 28078455DERIVED

Limitations and Caveats

We modified three previously validated scales to create a 35-point scale to evaluate participants; therefore, the validity of these scales may have been impacted.

Results Point of Contact

Title
Dr. Lauren Thomaier
Organization
Johns Hopkins University
lthomai1@jhmi.edu
410-955-6710

Study Officials

  • Chi Chiung Grace Chen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

February 24, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 28, 2017

Results First Posted

August 28, 2017

Record last verified: 2017-07