NCT01799577

Brief Summary

This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 3, 2014

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

February 13, 2013

Last Update Submit

December 31, 2013

Conditions

Diagnostic Self Evaluation

Keywords

laparoscopy, accuracy, duration

Outcome Measures

Primary Outcomes (1)

  • In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.

    We want to test the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model. 7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks in term of total task time and error number.

    15 days

Study Arms (1)

Gynecologist

Gynecologist can use laparoscopic surgery.

Procedure: Laparoscopic surgery

Interventions

Laparoscopic surgeryPROCEDURE

Two methods will be compare

Gynecologist

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Medical doctors

You may qualify if:

  • medical doctors

You may not qualify if:

  • disabled person (about arms or vision problems)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Trainig and Research Hospital

Istanbul, 12345, Turkey (Türkiye)

Location

Related Publications (1)

  • Usta TA, Ozkaynak A, Kovalak E, Ergul E, Naki MM, Kaya E. An assessment of the new generation three-dimensional high definition laparoscopic vision system on surgical skills: a randomized prospective study. Surg Endosc. 2015 Aug;29(8):2305-13. doi: 10.1007/s00464-014-3949-0. Epub 2014 Nov 21.

    PMID: 25414065DERIVED

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • TANER USTA, M.D.

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 27, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 3, 2014

Record last verified: 2013-12

Locations

TU(1)