NCT07433439已完成不适用
Prophylactic Mesh Placement Reduces the Incidence of Incisional Hernia in HBP Surgery.
Juan Bellido-Luque.MD1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年7月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- image detected IH rate
研究概览
简要总结
he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is:
will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer?
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or older.
- •Elective conventional or extensive right subcostal laparotomy.
- •Two or more risk Factor for incisional hernia (IH): > 60 years, Body Mass Index > 27 kg/m2, Diabetes Mellitus, pulmonary/liver/renal disease, malignancy, preoperative chemotherapy, immunosuppression or smoking
- •Life expectancy of at least 12 months.
- •Signed informed consent with agreement to attend all study visits.
排除标准
- •Emergency surgery.
- •Previous right subcostal hernia or right subcostal incision.
- •Metastatic disease or irresectable malignancy identified during the surgery with life expectancy less than 12 months.
- •Active abdominal infection at the time of surgery
研究组 & 干预措施
Mesh group
Experimental
group in which a mesh is placed
干预措施: mesh placement (Procedure)
non mesh group
Active Comparator
group in which a mesh is not placed
干预措施: conventional abdominal wall closure without mesh (Other)
结局指标
主要结局
image detected IH rate
时间窗: 12 and 24 months
incisional hernia rate after 12 and 24 posoperative months
次要结局
- incision types(day 1 (surgical procedure))
- postoperative complications(3-6-12-24 postoperative months)
研究者
Juan Bellido-Luque.MD
medical doctor
Hospital Quiron Sagrado Corazon
研究点 (1)
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