Trial Outcomes & Findings for Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models (NCT NCT02895347)

Results Overview

GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Three weeks after orientation

Results posted on

2017-04-18

Participant Flow

Of the 40 subjects who consented to participate in the study, 4 subjects failed to complete study procedures and dropped out of the study. Reason for this included inability to attend the final assessment and subjects unwilling to perform the final study assessment on a live porcine model.

Participant milestones

Participant milestones
Measure	Control Group Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
Overall Study STARTED	20	20
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=20 Participants Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group n=20 Participants Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.	Total n=40 Participants Total of all reporting groups
Age, Continuous	25 years n=5 Participants	25 years n=7 Participants	25 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Three weeks after orientation

GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.

Outcome measures

Outcome measures
Measure	Control Group n=17 Participants Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group n=19 Participants Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
Global Evaluative Assessment of Robotic Skills (GEARS) Scale	15.25 units on a scale Standard Deviation 3.38	15.37 units on a scale Standard Deviation 2.51

PRIMARY outcome

Timeframe: Three weeks after orientation

time, measured in minutes, it took each participant to perform the suturing activity

Outcome measures

Outcome measures
Measure	Control Group n=17 Participants Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group n=19 Participants Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
Amount Time to Suture	9.9 minutes Standard Deviation 2.07	9.2 minutes Standard Deviation 2.65

PRIMARY outcome

Timeframe: assessed after the orientation and prior to the three week date for the final suturing assessment

time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.

Outcome measures

Outcome measures
Measure	Control Group n=19 Participants Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.	Experimental Group Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
Amount of Time to Achieve Proficiency	116 minutes Interval 53.0 to 209.0	—

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gaby Moawad

GWU Medical Faculty Associates

Phone: 202-741-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place