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

  • STATUS
    Recruiting
  • End date
    Nov 20, 2023
  • participants needed
    54
  • sponsor
    Hospices Civils de Lyon
Updated on 25 January 2021
brimonidine tartrate ophthalmic solution
sacrocolpopexy
cystocele
uterine prolapse

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.

Details
Condition Ptosis, Genitourinary Prolapse, prolapse, prolapses
Treatment Synthetic glue IfabondTM, Glue-Free Suture Technique
Clinical Study IdentifierNCT03307824
SponsorHospices Civils de Lyon
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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