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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01405-48 | Other Identifier | ID-RCB |
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Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of anterior and apical prolapse. In order to provide an alternative to stapling system and sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy significantly reduces the time of surgery compared to the classic suture technique. The prospective, randomized, multicenter study therefore aims to compare the time of surgery when using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in laparoscopic sacrocolpopexy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IfabondTM | Experimental | Use of the synthetic glue IfabondTM |
|
| sutures | Active Comparator | Glue-Free Suture Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic glue IfabondTM | Device | Use of the synthetic glue IfabondTM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| duration of surgery | time of surgery in minutes (measured by chronometers) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage prolapse correction failure | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification | at 1 months post-surgery |
| Percentage prolapse correction failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Géry LAMBLIN, MD | Gynaecology Department, Hôpital Femme Mère Enfant, HCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecology Department, Hôpital Femme Mère Enfant | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Glue-Free Suture Technique |
| Procedure |
Suture Technique |
|
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
| at 12 months post-surgery |
| Percentage prolapse correction failure | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification | at 24 months post-surgery |
| complications | at day 0 |
| complications | at 1 months post-surgery |
| complications | at 12 months post-surgery |
| complications | at 24 months post-surgery |
| pain | assessed by visual analog scale (VAS) | at day 0 |
| pain | assessed by visual analog scale (VAS) | at 1 months post-surgery |
| pain | assessed by visual analog scale (VAS) | at 12 months post-surgery |
| pain | assessed by visual analog scale (VAS) | at 24 months post-surgery |
| quality of life | assessed by the questionnaires Short Form Health Survey-12 (SF-12) | at 1 months post-surgery |
| quality of life | assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20) | at 1 months post-surgery |
| quality of life | assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7) | at 1 months post-surgery |
| quality of life | assessed by the questionnaires Patient Global Impression of Improvement (PGI-I) | at 1 months post-surgery |
| quality of life | assessed by the questionnaires SF-12 | at 12 months post-surgery |
| quality of life | assessed by the questionnaires PFDI-20 | at 12 months post-surgery |
| quality of life | assessed by the questionnaires PFIQ-7 | at 12 months post-surgery |
| quality of life | assessed by the questionnaires PGI-I | at 12 months post-surgery |
| quality of life | assessed by the questionnaires SF-12 | at 24 months post-surgery |
| quality of life | assessed by the questionnaires PFDI-20 | at 24 months post-surgery |
| quality of life | assessed by the questionnaires PFIQ-7 | at 24 months post-surgery |
| quality of life | assessed by the questionnaires PGI-I | at 24 months post-surgery |
| sexuality score | assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12) | at 1 months post-surgery |
| sexuality score | assessed by the questionnaire PISQ-12 | at 12 months post-surgery |
| sexuality score | assessed by the questionnaire PISQ-12 | at 24 months post-surgery |
| percentage of dyspareunia | at 1 months post-surgery |
| percentage of dyspareunia | at 12 months post-surgery |
| percentage of dyspareunia | at 24 months post-surgery |
| percentage of urinary incontinence | at 1 months post-surgery |
| percentage of urinary incontinence | at 12 months post-surgery |
| percentage of urinary incontinence | at 24 months post-surgery |