Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Conditions
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Medial and/or Anterior Genital Prolapse

Intervention / Treatment
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* Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFABOND<br> | Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage prolapse correction failure |  | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage prolapse correction failure |  | 24 months post-surgery | 
| Percentage immediate postoperative failure |  | 1 month post-surgery | 
| Complications rate |  | Peroperative and 1, 12 and 24 months post-surgery | 
| Quality of life score |  | 1, 12 and 24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue