NCT04538768Unknown不适用
Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Buccheri La Ferla Hospital, Palermo2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
研究概览
简要总结
The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.
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
- •patients > 18 y.o.
- •stomal closure
- •elective surgery
排除标准
- •patients < 18 y.o.
- •emergency surgery
结局指标
主要结局
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
时间窗: 1 week to 18 months after surgery
the outcome 1 will be assessed through clinical examination during follow up time. when the suspicion of incisional hernia will be hypothesized the patients will be conducted to perform US of the abdomen and CT scan of the abdomen if strictly required to confirm the suspicion.
次要结局
- rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.(1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery)
- rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.(1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery)
- rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.(1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery)
- surgical operation time in P4HB mesh placement group vs direct fascia suture group.(intraoperative)
- length of hospital stay in P4HB mesh placement group vs direct fascia suture group.(From the starting date of the study until the date of its completion, assessed up to 18 months")
- assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.(18 months after surgery.)
- cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.(through study completion, an average of 1 year .)
研究者
Leo Licari
Principal Investigator
Buccheri La Ferla Hospital, Palermo
研究点 (2)
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