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OpenTrials
Completed

NCT Number: NCT01618994

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

About this study

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:

  • Blood loss- 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- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
  • Surgeon console biometrics- As measured by controller movements and grips
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must not have performed a da Vinci assisted surgery

Exclusion criteria

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

Treatment and study plan

Performing robotic supracervical hysterectomy

Procedure

All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy

Primary outcomes

  1. Surgical Time

    Time frame: At end of cervical amputation

    As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation

Secondary outcomes

  1. Blood Loss

    Time frame: End of cervical amputation

    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

    Time frame: Within a month of the performed surgery

    All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet

  3. Surgeon Console Biometrics

    Time frame: during surgery

    As measured by controller movements and grip

  4. Novice Robotic Surgeon Data

    Time frame: Within a month of the performed surgery

    Descriptive Operative data of surgeons who did not participate in robotic simulator training

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Collaborators

  • Intuitive Surgical

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2012
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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