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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00258-39 | Other Identifier | ID-RCB number, ANSM |
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The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.
The secondary objectives of this study are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic sacrocolpopexy | Other | laparoscopic sacrocolpopexy |
|
| vaginal mesh surgery | Other | vaginal mesh surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sacrocolpopexy | Other |
| ||
| vaginal mesh surgery |
| Measure | Description | Time Frame |
|---|---|---|
| PFDI-20 score | The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe LUCOT, MD, | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sébatien BLANC | Annecy | 74374 | France | |||
| Hôpital Antoine Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23618743 | Background | Lucot JP, Fritel X, Debodinance P, Bader G, Cosson M, Giraudet G, Collinet P, Rubod C, Fernandez H, Fournet S, Lesavre M, Deffieux X, Faivre E, Trichot C, Demoulin G, Jacquetin B, Savary D, Botchorichvili R, Campagne Loiseau S, Salet-Lizee D, Villet R, Gadonneix P, Delporte P, Ferry P, Aucouturier JS, Thirouard Y, de Tayrac R, Fatton B, Wagner L, Nadeau C, Wattiez A, Garbin O, Youssef Azer Akladios C, Thoma V, Baulon Thaveau E, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Fauconnier A; GROG (groupe de recherche en gynecologie et obstetrique). [PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. J Gynecol Obstet Biol Reprod (Paris). 2013 Jun;42(4):334-41. doi: 10.1016/j.jgyn.2013.03.012. Epub 2013 Apr 22. French. | |
| 29472143 |
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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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| Other |
|
| 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 |
| 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |