Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery

May 5, 2016 updated by: Atlantic Health System
The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training
  • Completion of the online orientation to daVinci Surgical System

Exclusion Criteria:

  • Performance of any robotic surgical procedures as the console surgeon
  • Performance of any robotic simulator protocols
  • Any significant amount of time spent on a virtual reality robotic simulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mimic dV-Trainer
Other: Mimic dv-Trainer
Other: daVinci Skills Simulator
Other: daVinci Skills Simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: at time of supracervical hysterectomy
Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os.
at time of supracervical hysterectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Blood Loss
Time Frame: during the surgical procedure
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
during the surgical procedure
Surgical Skill Rating
Time Frame: following completion of the procedure
As measured by the global assessment tool for evaluation of intraoperative laparoscopic skills (GOALS) tool via video assessment. These ratings will be performed by a group of surgeons who are not involved in the study and are masked as to the identity of the study surgeons.
following completion of the procedure
Continued success with robotic surgery after participation in the study
Time Frame: during the 12 months following surgical procedure
The number of cases each participating resident performs as primary surgeon the 12 months after completion of the study will be recorded
during the 12 months following surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 574541-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Simulation for Preparation of Robotic Surgery

Clinical Trials on Mimic dv-Trainer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe