NCT02011373已完成不适用
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Percentage prolapse correction failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
IFABOND
Experimental
干预措施: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ (Procedure)
结局指标
主要结局
Percentage prolapse correction failure
时间窗: 12 months post-surgery
次要结局
- Percentage immediate postoperative failure(1 month post-surgery)
- Percentage prolapse correction failure(24 months post-surgery)
- Quality of life score(1, 12 and 24 months post-surgery)
- Complications rate(Peroperative and 1, 12 and 24 months post-surgery)
研究者
研究点 (6)
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