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Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Sacro-Spinous Support | Anterior sacro-spinous mesh implants supported patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Sacro-Spinous | Procedure | Anterior Sacro-Spinous |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change With Distance Between the Vaginal Apex and the Introitus | The change with distance measured by centimeters, between the vaginal apex and the introitus | One year |
| Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring | Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening. | one year |
| Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure | Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients suffering advanced pelvic organ prolapse with anterior predominance and apical supportive defect, reffered to mesh reconstruction.
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| Name | Affiliation | Role |
|---|---|---|
| Menahem Neuman, Prof. | Western Galilee MC | Principal Investigator |
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The study patients were retrieved out of the operated patients population during the study period.
44 patients with significant Pelvic Organ Prolapse requiring mesh reconstruction during 2011-2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Anterior Sacro-Spinos Support | Anterior Sacro-Spinous Support : |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anterior Sacro-Spinos Support | Anterior Sacro-Spinous Support : |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change With Distance Between the Vaginal Apex and the Introitus | The change with distance measured by centimeters, between the vaginal apex and the introitus | Posted | Mean | Full Range | centimeters | One year |
|
|
one year
Urinary tract injury, intestinal injury, nerve injury, bleeding, mesh exposure, infection,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anterior Sacro-Spinos Support | Anterior Sacro-Spinous Support : |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Menahem Neuman | Western Galilee MC | +972546444033 | mneuman@netvision.net.il |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring | Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening. | Posted | Number | participants | one year |
|
|
|
| Primary | Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure | Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure. | occurrence and severity of complication is recorded | Posted | Number | participants | one year |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
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