Clinical trial NCT02011373: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
Official title: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medial and/or Anterior Genital Prolapse
Keywords: prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Vitalitec
First posted: 2013-12-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.


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: Percentage prolapse correction failure
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Percentage prolapse correction failure
timeFrame: 24 months post-surgery
measure: Percentage immediate postoperative failure
timeFrame: 1 month post-surgery
measure: Complications rate
timeFrame: Peroperative and 1, 12 and 24 months post-surgery
measure: Quality of life score
timeFrame: 1, 12 and 24 months post-surgery
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
city: Pierre-Bénite
country: France
facility: Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
name: Gery Lamblin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20.