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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy

Conditions
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Prolapse

Intervention / Treatment
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* Device: Synthetic glue IfabondTM
* Procedure: Glue-Free Suture Technique


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IfabondTM<br>Use of the synthetic glue IfabondTM | Device: Synthetic glue IfabondTM<br>* Use of the synthetic glue IfabondTM<br>|
| Active Comparator: sutures<br>Glue-Free Suture Technique | Procedure: Glue-Free Suture Technique<br>* Suture Technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgery | time of surgery in minutes (measured by chronometers) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage prolapse correction failure | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification | at 1 months post-surgery | 
| Percentage prolapse correction failure | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification | at 12 months post-surgery | 
| Percentage prolapse correction failure | A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification | at 24 months post-surgery | 
| complications |  | at day 0 | 
| complications |  | at 1 months post-surgery | 
| complications |  | at 12 months post-surgery | 
| complications |  | at 24 months post-surgery | 
| pain | assessed by visual analog scale (VAS) | at day 0 | 
| pain | assessed by visual analog scale (VAS) | at 1 months post-surgery | 
| pain | assessed by visual analog scale (VAS) | at 12 months post-surgery | 
| pain | assessed by visual analog scale (VAS) | at 24 months post-surgery | 
| quality of life | assessed by the questionnaires Short Form Health Survey-12 (SF-12) | at 1 months post-surgery | 
| quality of life | assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20) | at 1 months post-surgery | 
| quality of life | assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7) | at 1 months post-surgery | 
| quality of life | assessed by the questionnaires Patient Global Impression of Improvement (PGI-I) | at 1 months post-surgery | 
| quality of life | assessed by the questionnaires SF-12 | at 12 months post-surgery | 
| quality of life | assessed by the questionnaires PFDI-20 | at 12 months post-surgery | 
| quality of life | assessed by the questionnaires PFIQ-7 | at 12 months post-surgery | 
| quality of life | assessed by the questionnaires PGI-I | at 12 months post-surgery | 
| quality of life | assessed by the questionnaires SF-12 | at 24 months post-surgery | 
| quality of life | assessed by the questionnaires PFDI-20 | at 24 months post-surgery | 
| quality of life | assessed by the questionnaires PFIQ-7 | at 24 months post-surgery | 
| quality of life | assessed by the questionnaires PGI-I | at 24 months post-surgery | 
| sexuality score | assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12) | at 1 months post-surgery | 
| sexuality score | assessed by the questionnaire PISQ-12 | at 12 months post-surgery | 
| sexuality score | assessed by the questionnaire PISQ-12 | at 24 months post-surgery | 
| percentage of dyspareunia |  | at 1 months post-surgery | 
| percentage of dyspareunia |  | at 12 months post-surgery | 
| percentage of dyspareunia |  | at 24 months post-surgery | 
| percentage of urinary incontinence |  | at 1 months post-surgery | 
| percentage of urinary incontinence |  | at 12 months post-surgery | 
| percentage of urinary incontinence |  | at 24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Surgery, synthetic glue IFABONDTM, time of surgery