NCT01618994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

June 11, 2012

Last Update Submit

June 8, 2017

Conditions

Pelvic Organ Prolapse

Keywords

Robotic SimulatorEBLRobotic SurgeonsIntuitive Surgicalsimulation modulesbenchmarksMorristown ProtocolStudy SurgeonsControl SurgeonsExpert Surgeonsdual-console daVinci systemblinded skill assessment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Arms (3)

Expert Surgeons

Gynecologic robotic surgeons, each averaging \>75 robotic cases per year

Procedure: Performing robotic supracervical hysterectomy

Study Surgeons

Gynecologic surgeons who are completely naive to robotics

Procedure: Performing 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

Interventions

Performing robotic supracervical hysterectomyPROCEDURE

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

Control SurgeonsExpert SurgeonsStudy Surgeons

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gynecologic surgeons with no robotic experience

You may qualify if:

  • Must not have performed a da Vinci assisted surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Culligan, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

  • Charbel Salamon, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 14, 2012

Study Start

April 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(1)