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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-07-31

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.

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Detailed Description

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Conditions

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Anterior Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Traditional surgical method without prosthesis

Group Type ACTIVE_COMPARATOR

Traditional surgery

Intervention Type PROCEDURE

Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).

2

Surgical method with Perigee prosthesis

Group Type EXPERIMENTAL

Perigee® prosthesis

Intervention Type DEVICE

Surgical method with Perigee® prosthesis

Interventions

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Traditional surgery

Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).

Intervention Type PROCEDURE

Perigee® prosthesis

Surgical method with Perigee® prosthesis

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No