Comparison of polypropylene versus polyester mesh in the Lichtenstein hernia repair with respect to chronic pain and inflammatory changes
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To compare the postoperative pain following Lichtenstein inguinal hernioplasty using polyester vs. polypropylene mesh
研究概览
简要总结
Inguinal hernias are the most common operative procedures performed by general surgeons. Various procedures described to improve outcome in terms of decrease chronic pain and recurrence. Lichtenstein hernia repair showed a significant reduction in recurrence and also chronic pain. Usage of lightweight mesh materials like polyester is found to reduce inguinal hernia pain as compared to polypropylene mesh and improve quality of life. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP.
Chronic pain is that pain which persists at the surgical site and nearby surrounding tissues 3 months after surgery. Despite adequate research chronic postoperative pain continues to be a significant problem in hernioplasty. Polyester mesh has a higher degree of connective tissue integration, it has less mesh contraction, less fibrous encapsulation and less stiffness around the mesh. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP, however, there is no significant difference between preoperative
level, 12 hr, 48hr, and 2weeks. The main reasons hypothesized for chronic groin pain are per-operative nerve damage, post-operative fibrosis, or mesh-related fibrosis. They have been classified as either neuropathic or non-neuropathic pain. The three nerves potentially involved are the Ilioinguinal Nerve (IIN), Iliohypogastric Nerve (IHN) and genital branch of the Genitofemoral Nerve (GFN). These nerves can be damaged either by trauma during dissection or retraction of tissues, or nerve entrapment from post-operative fibrosis, mesh-related fibrosis or sutures used to fix the mesh. Non-neuropathic causes are excessive scar formation resulting from prosthetic mesh reaction, the periosteal reaction from sutures or staples inserted into the pubic tubercle or due to rolled-up bulky mesh leading to mechanical pressure. Hereby we are conducting a study to compare the efficacy between polypropylene mesh and polyester mesh in terms of pain, inflammatory changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of age above 18 years with unilateral inguinal hernia presenting to PIMS undergoing surgery, willing to participate in this study.
排除标准
- •1.Patients with strangulated hernia, 2.Recurrent hernia.
结局指标
主要结局
To compare the postoperative pain following Lichtenstein inguinal hernioplasty using polyester vs. polypropylene mesh
时间窗: Post operatively after 1 week and after 3 months
次要结局
- 1. Assessment of inflammatory markers like [hsCRP, IL 6] in pre-op and postop at 12 hours(2.To document the duration of operative time, duration of hospital stay.)