NCT00860483

Brief Summary

The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

March 10, 2009

Last Update Submit

December 3, 2012

Conditions

Brain Function

Keywords

Comparison of experienced and novice laparoscopic surgeons

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic experience

    2010

Study Arms (1)

observational

NO INTERVENTION

This is an observational study. no intervention occurs in subjects. their performance in a laparoscopic trainer is observed and correlated with brain activity

Other: observational

Interventions

observationalOTHER

PET Scan

observational

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Urology resident or fellow at Long-Island Jewish Hospital
  • Urology attending surgeon with previous laparoscopic experience
  • Medical Student Research Fellow with no previous laparoscopic experience
  • Right hand dominant subjects
  • No known neorologic defect reported by the subject -

You may not qualify if:

  • Left-hand dominant subjects
  • Self-reported neurologic defect reported by the subject -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Louis R. Kavoussi, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Urology

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 12, 2009

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

November 1, 2009

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)