Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy (Procolle 2)

Civil Hospices of Lyon

Status

Completed

Conditions

Prolapse

Treatments

Procedure: Glue-Free Suture Technique

Device: Synthetic glue IfabondTM

Study type

Interventional

Funder types

Other

Identifiers

NCT03307824

69HCL16_0647

2017-A01405-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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