Procolle 2: Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IfabondTM Use of the synthetic glue IfabondTM |
Device: Synthetic glue IfabondTM
Use of the synthetic glue IfabondTM
|
| Active Comparator: sutures Glue-Free Suture Technique |
Procedure: Glue-Free Suture Technique
Suture Technique
|
Outcome Measures
Primary Outcome Measures
- duration of surgery [Day 0]
time of surgery in minutes (measured by chronometers)
Secondary Outcome Measures
- Percentage prolapse correction failure [at 1 months post-surgery]
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
- Percentage prolapse correction failure [at 12 months post-surgery]
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
- Percentage prolapse correction failure [at 24 months post-surgery]
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
- complications [at day 0]
- complications [at 1 months post-surgery]
- complications [at 12 months post-surgery]
- complications [at 24 months post-surgery]
- pain [at day 0]
assessed by visual analog scale (VAS)
- pain [at 1 months post-surgery]
assessed by visual analog scale (VAS)
- pain [at 12 months post-surgery]
assessed by visual analog scale (VAS)
- pain [at 24 months post-surgery]
assessed by visual analog scale (VAS)
- quality of life [at 1 months post-surgery]
assessed by the questionnaires Short Form Health Survey-12 (SF-12)
- quality of life [at 1 months post-surgery]
assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
- quality of life [at 1 months post-surgery]
assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
- quality of life [at 1 months post-surgery]
assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
- quality of life [at 12 months post-surgery]
assessed by the questionnaires SF-12
- quality of life [at 12 months post-surgery]
assessed by the questionnaires PFDI-20
- quality of life [at 12 months post-surgery]
assessed by the questionnaires PFIQ-7
- quality of life [at 12 months post-surgery]
assessed by the questionnaires PGI-I
- quality of life [at 24 months post-surgery]
assessed by the questionnaires SF-12
- quality of life [at 24 months post-surgery]
assessed by the questionnaires PFDI-20
- quality of life [at 24 months post-surgery]
assessed by the questionnaires PFIQ-7
- quality of life [at 24 months post-surgery]
assessed by the questionnaires PGI-I
- sexuality score [at 1 months post-surgery]
assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
- sexuality score [at 12 months post-surgery]
assessed by the questionnaire PISQ-12
- sexuality score [at 24 months post-surgery]
assessed by the questionnaire PISQ-12
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gynaecology Department, Hôpital Femme Mère Enfant | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Géry LAMBLIN, MD, Gynaecology Department, Hôpital Femme Mère Enfant, HCL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL16_0647
- 2017-A01405-48