Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Mortality after FLaPp® prosthesis
研究概览
简要总结
Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.
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
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic patients with midline Large incisional hernia
排除标准
- •lateral incisional hernias
- •collagen diseases
- •patients who recently have undergone chemotherapy and/or radiation therapy
- •patients with acquired immunodeficiency
结局指标
主要结局
Mortality after FLaPp® prosthesis
时间窗: One month
Rate of posoperative mortality after FLaPp® prosthesis
Evaluation of pain after FLaPp® prosthesis
时间窗: one month
Evaluation of postoperative pain through Visual Analague Scale
Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification
时间窗: one month
evaluation of feasibility of FLaPp® prosthesis in patients affected by LIH by the assessment of postoperative morbidity classified according to Clavien Dindo Classification
次要结局
- Patients' satisfatcion after FLaPp® prosthesis(36 months)
- incisional hernia recurrence at medium term(36 months)
研究者
Claudio Gambardella
Clinical Professor
University of Campania "Luigi Vanvitelli"