Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01618994
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study for Robotic Surgery Simulator
Sponsor:
Atlantic Health System
Organization:
Study Overview
Official Title:
Validation Study for Robotic Surgery Simulator
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to determine whether completing a rigorous simulation protocol could provide novice robotic surgeons with actual advanced surgical skills in an operating room setting.
Detailed Description:
Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.
Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.
Secondary Outcome measures:
1. Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
2. Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
3. Surgeon console biometrics- As measured by controller movements and grips
4. Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.
Methods: To create the simulator protocol, 5 robotic surgeons (each averaging \>75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability \>5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.
We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.
Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.
Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.
Secondary Outcome measures:
1. Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
2. Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
3. Surgeon console biometrics- As measured by controller movements and grips
4. Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.
Methods: To create the simulator protocol, 5 robotic surgeons (each averaging \>75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability \>5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.
We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.
Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: