Clinical trial NCT01618994: Validation Study for Robotic Surgery Simulator
Official title: Validation Study for Robotic Surgery Simulator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Robotic Simulator
EBL
Robotic Surgeons
Intuitive Surgical
simulation modules
benchmarks
Morristown Protocol
Study Surgeons
Control Surgeons
Expert Surgeons
dual-console daVinci system
blinded skill assessment
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2012-06-14
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecologic surgeons with no robotic experience

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.

Eligibility criteria: Inclusion Criteria:

* Must not have performed a da Vinci assisted surgery

Exclusion Criteria:

* prior experience on the da Vinci system or the robotic simulator

Primary outcomes:
measure: Surgical Time
timeFrame: At end of cervical amputation
Secondary outcomes:
measure: Blood Loss
timeFrame: End of cervical amputation
measure: Surgical Skill Rating
timeFrame: Within a month of the performed surgery
measure: Surgeon Console Biometrics
timeFrame: during surgery
measure: Novice Robotic Surgeon Data
timeFrame: Within a month of the performed surgery
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Patrick Culligan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlantic Health System
name: Charbel Salamon, MD
role: PRINCIPAL_INVESTIGATOR
References: