Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 420
- 主要终点
- Umbilical Hernia Recurrence
研究概览
简要总结
The goal of this study is to see which of two types of mesh is better for fixing an umbilical hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever. The researchers will check if the hernia comes back, how it affects the patient's quality of life, and if there are any problems after the surgery during a three-year period.
详细描述
The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and postoperative complications in umbilical hernia repair. Patients will be randomized into one of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort. The hernia recurrence, quality of life and postoperative outcomes to determine if the two meshes are non-inferior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Primary umbilical hernia repair (UHR) [as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus]
- •Undergoing elective laparoscopic or open repair
- •Defect size of 1-4cm2
- •Centers for Disease Control and Prevention (CDC) class 1 & 2 wounds
排除标准
- 未提供
结局指标
主要结局
Umbilical Hernia Recurrence
时间窗: 3-years postoperatively
The rate of hernia recurrence 3-years postoperatively
次要结局
- Postoperative Outcomes - Length of stay(3-years postoperatively)
- Postoperative Outcome - 30-day readmission(30-days postoperatively)
- Mesh Related Complication - Mesh infection(1-year postoperatively)
- Postoperative Outcome - Seroma(3-years postoperatively)
- Postoperative Outcomes - Mortality(3-years postoperatively)
- Mesh Related Complication - Mesh excision(1-year postoperatively)
- Postoperative Outcome - Hematoma(3-years postoperatively)
- Postoperative Outcomes - Intra-abdominal abscess(3-years postoperatively)
- Postoperative Outcome - Wound cellulitis(3-years postoperatively)
- Postoperative Outcome - Wound infection(3-years postoperatively)
- Quality of Life (QOL)(3-years postoperatively)
- Postoperative Outcome - Superficial wound breakdown(3-years postoperatively)