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The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Traditional surgical method without prosthesis |
|
| 2 | Experimental | Surgical method with Perigee prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional surgery | Procedure | Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correction of prolapse 2 years after surgery | 24 months | |
| Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence | at 3,12, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MELLIER Georges, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital femme Mère Enfant | Bron | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24573358 | Result | Lamblin G, Van-Nieuwenhuyse A, Chabert P, Lebail-Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. Int Urogynecol J. 2014 Jul;25(7):961-70. doi: 10.1007/s00192-014-2344-7. Epub 2014 Feb 27. |
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| Perigee® prosthesis | Device | Surgical method with Perigee® prosthesis |
|
| Pain after surgery | 24 months |
| Duration of intervention | 24 months |