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

Civil Hospices of Lyon

Status

Completed

Conditions

Anterior Prolapse

Treatments

Device: Perigee® prosthesis

Procedure: Traditional surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00859417

2007.485/28

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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