A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prolapse
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- duration of surgery
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
duration of surgery
Time Frame: Day 0
time of surgery in minutes (measured by chronometers)
Secondary Outcomes
- Percentage prolapse correction failure(at 24 months post-surgery)
- complications(at 24 months post-surgery)
- pain(at 24 months post-surgery)
- percentage of dyspareunia(at 24 months post-surgery)
- sexuality score(at 24 months post-surgery)
- quality of life(at 24 months post-surgery)
- percentage of urinary incontinence(at 24 months post-surgery)