Validation Study for Robotic Surgery Simulator

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.

Inclusion Criteria:

- Must not have performed a da Vinci assisted surgery

Exclusion Criteria:

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