Status:
COMPLETED
Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Anterior Prolapse
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
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 appea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00859417
Start Date
September 1 2008
End Date
July 1 2013
Last Update
May 28 2019
Active Locations (1)
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1
Hôpital femme Mère Enfant
Bron, France, 69677