A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- duration of surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IfabondTM
Use of the synthetic glue IfabondTM
干预措施: Synthetic glue IfabondTM (Device)
sutures
Glue-Free Suture Technique
干预措施: Glue-Free Suture Technique (Procedure)
结局指标
主要结局
duration of surgery
时间窗: Day 0
time of surgery in minutes (measured by chronometers)
次要结局
- Percentage prolapse correction failure(at 24 months post-surgery)
- complications(at 24 months post-surgery)
- pain(at 24 months post-surgery)
- percentage of dyspareunia(at 24 months post-surgery)
- sexuality score(at 24 months post-surgery)
- percentage of urinary incontinence(at 24 months post-surgery)
- quality of life(at 24 months post-surgery)