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Clinical Trials/NCT01618994
NCT01618994
Completed
Not Applicable

Validation Study for Robotic Surgery Simulator

Atlantic Health System1 site in 1 country14 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Atlantic Health System
Enrollment
14
Locations
1
Primary Endpoint
Surgical Time
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
January 2012
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Blood Loss(End of cervical amputation)
  • Surgical Skill Rating(Within a month of the performed surgery)
  • Surgeon Console Biometrics(during surgery)
  • Novice Robotic Surgeon Data(Within a month of the performed surgery)

Study Sites (1)

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