Validation Study for Robotic Surgery Simulator

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Performing robotic supracervical hysterectomy

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gynecologic surgeons with no robotic experience

Description

Inclusion Criteria:

• Must not have performed a da Vinci assisted surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Expert Surgeons; Gynecologic robotic surgeons, each averaging >75 robotic cases per year	Procedure: Performing robotic supracervical hysterectomy; All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
Study Surgeons; Gynecologic surgeons who are completely naive to robotics	Procedure: Performing robotic supracervical hysterectomy; All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
Control Surgeons; Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator	Procedure: Performing robotic supracervical hysterectomy; All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Time	As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation	At end of cervical amputation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume	End of cervical amputation
Surgical Skill Rating	All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet	Within a month of the performed surgery
Surgeon Console Biometrics	As measured by controller movements and grip	during surgery
Novice Robotic Surgeon Data	Descriptive Operative data of surgeons who did not participate in robotic simulator training	Within a month of the performed surgery

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Collaborators: Intuitive Surgical
• Investigators: Principal Investigator: Charbel Salamon, MD, Atlantic Health System

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 14, 2012

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: R11-01-018