Trial Outcomes & Findings for Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms (NCT NCT02370407)
NCT ID: NCT02370407
Last Updated: 2017-08-28
Results Overview
Primary outcome will be time to task completion (seconds) on the robotic task
COMPLETED
NA
40 participants
1 day of practice
2017-08-28
Participant Flow
Participant milestones
| Measure |
Laparoscopic Simulator
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).
a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator.
|
Mimic da Vinci Robotic Simulator
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).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms
Baseline characteristics by cohort
| Measure |
Laparoscopic Simulator
n=20 Participants
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).
a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator.
|
Mimic da Vinci Robotic Simulator
n=20 Participants
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).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 day of practicePrimary outcome will be time to task completion (seconds) on the robotic task
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Time to Task Completion (Robotic Task)
|
120 seconds
Standard Deviation 42
|
71 seconds
Standard Deviation 23
|
PRIMARY outcome
Timeframe: Study durationGlobal 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.
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Global Rating Scale Score on the Laparoscopic Task
|
22.5 units on a scale
Standard Deviation 3.8
|
16.3 units on a scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Study durationA 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.
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Global Rating Scale Score on the Robotic Task
|
16.9 units on a scale
Standard Deviation 5.4
|
23.5 units on a scale
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: 1 day of practiceTime to task completion (seconds) on the laparoscopic task
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Time to Task Completion on the Laparoscopic Task
|
100 seconds
Standard Deviation 29
|
158 seconds
Standard Deviation 65
|
SECONDARY outcome
Timeframe: Study duration(cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Economy of Motion on the Robotic Task
|
241 cm
Standard Deviation 57
|
161 cm
Standard Deviation 35
|
SECONDARY outcome
Timeframe: through study completionAutomatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Instrument Out of View
|
3.06 seconds
Standard Deviation 3.3
|
0.91 seconds
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: study durationAutomatically recorded data on the Mimic DV trainer which records number of collisions
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Instrument Collisions
|
2.8 number of events
Standard Deviation 4.3
|
1.1 number of events
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: study durationAutomatically recorded data on the Mimic DV trainer (seconds)
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Time Spent Using Excessive Force
|
0.28 seconds
Standard Deviation 0.58
|
0.24 seconds
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: study durationAutomatically recorded data on the Mimic DV trainer consisting of workspace range (cm, this is the widest range traveled by the 2 instruments, one in each hand), and number of peg drops
Outcome measures
| Measure |
Laparoscopic Group
n=20 Participants
Training on laparoscopic platform resulted in improved performance on laparoscopic and robotic task
|
Robotic Group
n=20 Participants
Training on robotic platform resulted in improved performance on laparoscopic and robotic task
|
|---|---|---|
|
Workspace Range
|
9.41 cm
Standard Deviation 2.3
|
9.34 cm
Standard Deviation 2.5
|
Adverse Events
Laparoscopic Simulator
Mimic da Vinci Robotic Simulator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place