Validation Study for Robotic Surgery Simulator

Pelvic Organ Prolapse Clinical Trial

Official title:

Validation Study for Robotic Surgery Simulator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618994
• Other study ID #: R11-01-018
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 8, 2017
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must not have performed a da Vinci assisted surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
United States	Morristown Medical Center	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Surgeon Console Biometrics	As measured by controller movements and grip	during surgery
Secondary	Novice Robotic Surgeon Data	Descriptive Operative data of surgeons who did not participate in robotic simulator training	Within a month of the performed surgery