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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00350-39 | Other Identifier | ID-RCB |
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Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue.
Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study.
The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anterior sacrospinofixation with autologous tissue | patients with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evolution of patient symptoms | Other | evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement of symptoms | percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3) | at Month 2 |
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Inclusion Criteria:
Exclusion Criteria:
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patients over 18 years old with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned.
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| Name | Affiliation | Role |
|---|---|---|
| Géry LAMBLIN, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | 69500 | France |
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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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