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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01282-39 | Other Identifier | ID-RCB number, ANSM |
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The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.
It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.
This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic sacropexy | Experimental | under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium. |
|
| vaginal mesh | Experimental | after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sacropexy | Procedure | under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium. |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity (Dindo Classification) | Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Specific complications | Comparison for the specific complications of sub-vesical mesh according to the route :
| 12 months |
| Medium-term tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe LUCOT, MD | CHRU de LILLE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sébatien BLANC | Annecy | 74374 | France | |||
| Hôpital Antoine Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29472143 | Result | Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19. |
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| ID | Term |
|---|---|
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| vaginal mesh | Procedure | after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory. |
|
|
Comparison of both techniques for the medium-term tolerance:
| 12 months |
| Clinical Efficiency | Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency:
| 12 months |
| Clamart |
| 92140 |
| France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| GCS Flandre Maritime | Grande-Synthe | 59760 | France |
| CH La Rochelle Service de Gynécologie Obstétrique | La Rochelle | 17019 | France |
| Hôpital BICETRE / Service de Gynécologie Obstétrique | Le Kremlin-Bicêtre | 94275 | France |
| CHRU de Lille - Service de Gynécologie médico chirurgicale | Lille | 59037 | France |
| CHU de Nîmes | Nîmes | 30029 | France |
| Groupe Hospitalier Diaconesses Croix St-Simon | Paris | 75571 | France |
| CHI Poissy-St-Germain / Service de gynécologie | Poissy | 78303 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| Hôpital de Hautepierre | Strasbourg | 67000 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |