Clinical trial NCT02370407: Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms
Official title: Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms in Surgical Skill Naive Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Simulation Education
Keywords: surgical education
minimally invasive surgical procedures
laparoscopic simulation
robotic simulation
medical education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: This is a randomized controlled trial that will randomize medical students to practice on a robotic simulator or a laparoscopic simulator. The investigators will first obtain baseline data by having the study participants perform one task (peg transfer exercise) on a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA), and a similar task on a robotic trainer (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA). Participants will then be randomized to practice on the robotic simulator or practice on the laparoscopic trainer for at least 10 repetitions. After the participants complete 10 repetitions, they will be evaluated again on both the laparoscopic and robotic simulator using time to task completion and Mimi DV trainer motion metrics. Two expert laparoscopic and robotic surgeons will also evaluate participant performance using previously validated global rating scales for robotic and laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Time to Task Completion (Robotic Task)
timeFrame: 1 day of practice
measure: Global Rating Scale Score on the Laparoscopic Task
timeFrame: Study duration
measure: Global Rating Scale Score on the Robotic Task
timeFrame: Study duration
measure: Time to Task Completion on the Laparoscopic Task
timeFrame: 1 day of practice
Secondary outcomes:
measure: Economy of Motion on the Robotic Task
timeFrame: Study duration
measure: Instrument Out of View
timeFrame: through study completion
measure: Instrument Collisions
timeFrame: study duration
measure: Time Spent Using Excessive Force
timeFrame: study duration
measure: Workspace Range
timeFrame: study duration
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Chi Chiung Grace Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.