Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Incidence of post-operative pain and its intensity using VAS Scale
研究概览
简要总结
The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.
详细描述
Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.
Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •All patients with primary inguinal hernia
- •Signed consent
排除标准
- •Recurrent hernia
- •Emergency procedure
- •Patient not willing to participate
结局指标
主要结局
Incidence of post-operative pain and its intensity using VAS Scale
时间窗: 12 Months
Assessment will be made using Visual Analogue Scale (VAS).
次要结局
- Rate of foreign body sensation - Subjective feeling of discomfort in the groin(12 Months)
- Duration of surgery(Day of surgery)
- Hernia recurrence rate(12 Months)
- Post-operative complications(12 Months)
- Incidence of Treatment-Emergent Adverse Events [Safety](12 Months)