Validation Study for Robotic Surgery Simulator

This study has been completed.
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01618994
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Procedure: Performing robotic supracervical hysterectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation Study for Robotic Surgery Simulator

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • Surgical Time [ Time Frame: At end of cervical amputation ] [ Designated as safety issue: No ]
    As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation


Secondary Outcome Measures:
  • Blood Loss [ Time Frame: End of cervical amputation ] [ Designated as safety issue: No ]
    As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume

  • Surgical Skill Rating [ Time Frame: Within a month of the performed surgery ] [ Designated as safety issue: No ]
    All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet

  • Surgeon Console Biometrics [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    As measured by controller movements and grip

  • Novice Robotic Surgeon Data [ Time Frame: Within a month of the performed surgery ] [ Designated as safety issue: No ]
    Descriptive Operative data of surgeons who did not participate in robotic simulator training


Enrollment: 14
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gynecologic surgeons with no robotic experience

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618994

Locations
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Intuitive Surgical
Investigators
Principal Investigator: Patrick Culligan, MD Atlantic Health System
Principal Investigator: Charbel Salamon, MD Atlantic Health System
  More Information

No publications provided

Responsible Party: Jodie Komar, Patrick Culligan, MD, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01618994     History of Changes
Other Study ID Numbers: R11-01-018
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
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:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014