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| Name | Class |
|---|---|
| Vitalitec | UNKNOWN |
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Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFABOND | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage prolapse correction failure | 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage prolapse correction failure | 24 months post-surgery | |
| Percentage immediate postoperative failure | 1 month post-surgery | |
| Complications rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gery Lamblin, MD | Gynaecology Department, Hôpital Femme Mère Enfant, Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecology Department, Hôpital Femme Mère Enfant | Bron | 69677 | France | |||
| Gynaecology Department, HĂ´pital de la Croix-Rousse, Hospices Civils de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33742249 | Result | Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20. |
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| Peroperative and 1, 12 and 24 months post-surgery |
| Quality of life score | 1, 12 and 24 months post-surgery |
| Lyon |
| 69004 |
| France |
| Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69495 | France |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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