Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy

A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy

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.

Inclusion Criteria:

• Woman aged 18 years or more
• Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse Quantification (POP-Q) classification (hysterocele and/or cystocele) requiring surgical correction
• Patient requesting surgery for the trouble caused by the prolapse

Exclusion Criteria:

• Prolapse of POP-Q stage <III or without functional impact
• Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc.
• Impaired lower-limb range of motion preventing positioning for surgery
• Pregnancy or intended pregnancy during study period
• Evolutive or latent infection or signs of tissue necrosis on clinical examination
• Non-controlled diabetes (glycated haemoglobin >8%)
• Treatment impacting immune response (immunomodulators), ongoing or within previous month
• History of pelvic region radiation therapy, at any time
• History of pelvic cancer
• Non-controlled evolutive spinal pathology
• Known hypersensitivity to one of the implant components (polypropylene)
• Cyanoacrylate hypersensitivity
• Formaldehyde hypersensitivity
• Inability to understand information provided
• No national health insurance cover; prisoner, or ward of court