Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

Study Overview
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Brief Summary
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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.

Official Title
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PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

Conditions
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Anterior Prolapse

Intervention / Treatment
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* Procedure: Traditional surgery
* Device: Perigee® prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 18 years old Genital anterior prolapse requiring surgical correction and with stage III or IV in the classification of Pelvic Organ Prolapse - Quantification or POP-Q Ability to understand the information and to sign a consent form Patients wishing an intervention because of the inconvenience caused by the prolapse. Exclusion Criteria: Prolapse stage <III in the classification POP-Q, and prolapse without functional inconvenience Progressive or latent infection, or signs of tissue necrosis in the clinical examination Troubles resulting in an unacceptable risk of post-surgery complications investigated at the interview with the patient (disorders of blood clotting, immune system disorders, progressive diseases….) Mobility of the lower limbs reduced (not permitting the positioning for the surgery) Pregnancy or any desire of pregnancy during the study, within two years Pelvic surgery in the last 6 months Patients who have had radiotherapy of the pelvic area in an irrespective time A history of pelvic cancer Known hypersensitivity to any component of the prosthesis (polypropylene) Uncontrolled diabetes (HbA1c> 8%) Treatment modifying the immune response (immuno-modulators), current or stopped for less than one month Inability to understand the information and to sign a consent A person not subject to social security, deprived of freedom, or under legal guardian

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Traditional surgical method without prosthesis | Procedure: Traditional surgery<br>* Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).<br>|
| Experimental: 2<br>Surgical method with Perigee prosthesis | Device: Perigee® prosthesis<br>* Surgical method with Perigee® prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Pain after surgery |  | 24 months | 
| Duration of intervention |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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correction of anterior prolapse, prosthetic trans-obturator way kit, randomized study