Medial and/or Anterior Genital Prolapse
Conditions
Keywords
prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
Brief summary
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.
Interventions
PROCEDUREfixation technique using a sterile synthetic liquid tissue glue: IFABOND™
Sponsors
Vitalitec
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage prolapse correction failure | 12 months post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| Percentage prolapse correction failure | 24 months post-surgery |
| Percentage immediate postoperative failure | 1 month post-surgery |
| Complications rate | Peroperative and 1, 12 and 24 months post-surgery |
| Quality of life score | 1, 12 and 24 months post-surgery |
Countries
France
Outcome results
None listed