Study Results
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View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2013-11-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
3D laparoscopy
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System
The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
Interventions
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Storz 3D Laparoscopy System
The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
FEMALE
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Jon I. Einarsson
Division Chair, Minimally Invasive Gynecology
Principal Investigators
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Jon Einarsson, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Sarah L Cohen, MD, MPH
Role: STUDY_DIRECTOR
Brigham and Women's Hospital
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Odense University Hospital
Odense, , Denmark
Countries
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References
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Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
Ajao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6.
Other Identifiers
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3DRCT
Identifier Type: -
Identifier Source: org_study_id
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