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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, France
Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France
Percentage prolapse correction failure
Time frame: 12 months post-surgery
Percentage prolapse correction failure
Time frame: 24 months post-surgery
Percentage immediate postoperative failure
Time frame: 1 month post-surgery
Complications rate
Time frame: Peroperative and 1, 12 and 24 months post-surgery
Quality of life score
Time frame: 1, 12 and 24 months post-surgery
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