Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
NCT ID: NCT02258230
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
194 participants
INTERVENTIONAL
2014-12-31
2018-03-31
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
TREATMENT
SINGLE
Study Groups
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2D mode LSC
2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
3D mode LSC
3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
2D mode PVR
2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
3D mode PVR
3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Interventions
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3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Eligibility Criteria
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Inclusion Criteria
And/Or
* Symptomatic cystocele (stage 2 or greater, point Aa or Ba \> -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair
Exclusion Criteria
* Inability to comprehend questionnaires
* Inability to give informed consent or to return for review
* Vaginal vault prolapse \< stage 2
* Unable to undergo general anesthesia
* More than 5 previous laparotomies
* Prior sacral colpopexy or vaginal mesh prolapse procedure
* Prior surgery involving the retropubic space
* Vaginal length less than 6 cm
18 Years
FEMALE
No
Sponsors
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International Urogynecology Associates
UNKNOWN
Olympus Corporation of the Americas
INDUSTRY
Responsible Party
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Principal Investigators
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Robert D Moore, DO
Role: PRINCIPAL_INVESTIGATOR
International Urogynecology Associates
Locations
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Beverly Hills Sunset Surgery Center
Los Angeles, California, United States
Northside Hospital
Atlanta, Georgia, United States
Countries
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Related Links
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International Urogynecology Associates' website
Other Identifiers
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4859
Identifier Type: -
Identifier Source: org_study_id
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