Prolapse
Conditions
Keywords
Laparoscopic Surgery, synthetic glue IFABONDTM, time of surgery
Brief summary
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.
Interventions
DEVICESynthetic glue IfabondTM
Use of the synthetic glue IfabondTM
PROCEDUREGlue-Free Suture Technique
Suture Technique
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 | Description |
|---|---|---|
| duration of surgery | Day 0 | time of surgery in minutes (measured by chronometers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications | at day 0 | — |
| pain | at day 0 | assessed by visual analog scale (VAS) |
| quality of life | at 1 months post-surgery | assessed by the questionnaires Short Form Health Survey-12 (SF-12) |
| Percentage prolapse correction failure | at 1 months post-surgery | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification |
| percentage of dyspareunia | at 1 months post-surgery | — |
| percentage of urinary incontinence | at 1 months post-surgery | — |
| sexuality score | at 1 months post-surgery | assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12) |
Countries
France
Outcome results
None listed