Anterior Prolapse Clinical Trial
Official title:
PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.
| NCT number | NCT00859417 |
| Other study ID # | 2007.485/28 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2008 |
| Est. completion date | July 2013 |
| Verified date | November 2013 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 78 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital femme Mère Enfant | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
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: 1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery | 12 months | ||
| Secondary | Correction of prolapse 2 years after surgery | 24 months | ||
| Secondary | Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence | at 3,12, 24 months | ||
| Secondary | Pain after surgery | 24 months | ||
| Secondary | Duration of intervention | 24 months |