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| Name | Class |
|---|---|
| International Urogynecology Associates | UNKNOWN |
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Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D mode LSC | Active Comparator | 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. |
|
| 3D mode LSC | Active Comparator | 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. |
|
| 2D mode PVR | Active Comparator | 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. |
|
| 3D mode PVR | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D mode of the 3D Laparoscopic Video System | Device | Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Times | Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure. | Intraoperative up to 6 weeks post procedure |
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Inclusion Criteria:
And/Or
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Moore, DO | International Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Sunset Surgery Center | Los Angeles | California | 90069 | United States | ||
| Northside Hospital |
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| Label | URL |
|---|---|
| International Urogynecology Associates' website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2022 | |
| Reset | Feb 14, 2022 |
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| 2D mode of the 3D Laparoscopic Video System | Device | Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope. |
|
| Atlanta |
| Georgia |
| 30342 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2022 | Feb 14, 2022 |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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