Ventral Hernia Prevention After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of ventral hernia
研究概览
简要总结
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
详细描述
Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.
PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •First transplantation
- •Signed Informed Consent
排除标准
- •Combined transplantation
- •Revisions after liver transplantation
- •Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
- •Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
- •Pregnant/lactating women
- •Known allergies to tetracycline hydrochloride and kanamycin sulfate
结局指标
主要结局
Incidence of ventral hernia
时间窗: 12 months after liver transplantation
Evaluated by ultra-sound imaging
次要结局
- Wound healing disorders(12 months after liver transplantation)
- Hematoma(12 months after liver transplantation)
- Seroma(12 months after liver transplantation)
- Infections(12 months after liver transplantation)