Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Study Details
Study Description
Brief Summary
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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. |
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
|
Active Comparator: 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. |
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
|
Active Comparator: 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. |
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
|
Active Comparator: 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. |
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
|
Outcome Measures
Primary Outcome Measures
- Operative Times [Intraoperative]
Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.
Secondary Outcome Measures
- Complications [Intraoperative up to 6 weeks post procedure]
Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy
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:
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Age less than 18 years
-
Inability to comprehend questionnaires
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Inability to give informed consent or to return for review
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Vaginal vault prolapse < stage 2
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Unable to undergo general anesthesia
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More than 5 previous laparotomies
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Prior sacral colpopexy or vaginal mesh prolapse procedure
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Prior surgery involving the retropubic space
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Vaginal length less than 6 cm
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beverly Hills Sunset Surgery Center | Los Angeles | California | United States | 90069 |
2 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
Sponsors and Collaborators
- Olympus Corporation of the Americas
- International Urogynecology Associates
Investigators
- Principal Investigator: Robert D Moore, DO, International Urogynecology Associates
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 4859