Clinical trial NCT03307824: Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy
Official title: A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: Laparoscopic Surgery
synthetic glue IFABONDTM
time of surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: duration of surgery
timeFrame: Day 0
Secondary outcomes:
measure: Percentage prolapse correction failure
timeFrame: at 1 months post-surgery
measure: Percentage prolapse correction failure
timeFrame: at 12 months post-surgery
measure: Percentage prolapse correction failure
timeFrame: at 24 months post-surgery
measure: complications
timeFrame: at day 0
measure: complications
timeFrame: at 1 months post-surgery
measure: complications
timeFrame: at 12 months post-surgery
measure: complications
timeFrame: at 24 months post-surgery
measure: pain
timeFrame: at day 0
measure: pain
timeFrame: at 1 months post-surgery
measure: pain
timeFrame: at 12 months post-surgery
measure: pain
timeFrame: at 24 months post-surgery
measure: quality of life
timeFrame: at 1 months post-surgery
measure: quality of life
timeFrame: at 1 months post-surgery
measure: quality of life
timeFrame: at 1 months post-surgery
measure: quality of life
timeFrame: at 1 months post-surgery
measure: quality of life
timeFrame: at 12 months post-surgery
measure: quality of life
timeFrame: at 12 months post-surgery
measure: quality of life
timeFrame: at 12 months post-surgery
measure: quality of life
timeFrame: at 12 months post-surgery
measure: quality of life
timeFrame: at 24 months post-surgery
measure: quality of life
timeFrame: at 24 months post-surgery
measure: quality of life
timeFrame: at 24 months post-surgery
measure: quality of life
timeFrame: at 24 months post-surgery
measure: sexuality score
timeFrame: at 1 months post-surgery
measure: sexuality score
timeFrame: at 12 months post-surgery
measure: sexuality score
timeFrame: at 24 months post-surgery
measure: percentage of dyspareunia
timeFrame: at 1 months post-surgery
measure: percentage of dyspareunia
timeFrame: at 12 months post-surgery
measure: percentage of dyspareunia
timeFrame: at 24 months post-surgery
measure: percentage of urinary incontinence
timeFrame: at 1 months post-surgery
measure: percentage of urinary incontinence
timeFrame: at 12 months post-surgery
measure: percentage of urinary incontinence
timeFrame: at 24 months post-surgery
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant
Study officials:
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant, HCL
name: Géry LAMBLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: