Comparative Study of Staples Versus Polypropylene Sutures for Mesh Fixation in Lichenstein's Tension-free Inguinal Hernia Repair in Terms of Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Postoperative pain (VAS score)
研究概览
简要总结
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.
详细描述
Inguinal hernia repair is one of the most common general surgical procedures worldwide. The standard method for mesh fixation during Lichtenstein tension-free hernioplasty uses polypropylene sutures. However, skin staples have recently been introduced as a faster and potentially less painful alternative. This randomized controlled trial compares both methods in terms of postoperative pain, measured using the Visual Analogue Scale (VAS), and operative time.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 20 to 60 years.
- •Patients undergoing elective Lichtenstein tension-free mesh repair for unilateral, uncomplicated inguinal hernia (direct or indirect).
- •Body Mass Index (BMI) between 19 and 30 kg/m².
- •ASA physical status I, II, or III.
- •Patients willing to participate and provide informed consent.
排除标准
- •Diabetic patients (on medical records).
- •Bilateral or recurrent inguinal hernia.
- •Complicated hernia (irreducible, obstructed, or strangulated).
- •Patients unwilling to participate or who fail to complete follow-up.
研究组 & 干预措施
Staples for mesh fixation
Mesh secured with stainless steel staples during Lichenstein tension-free inguinal hernioplasty
干预措施: Staples for mesh fixation (Procedure)
Polypropylene Suture Group
Mesh secured with polypropylene sutures during Lichensteins tension-free inguinal hernioplasty
干预措施: Polypropylene suture for mesh fixation (Procedure)
结局指标
主要结局
Postoperative pain (VAS score)
时间窗: Postoperative day 1, day 7 and day 30
Pain intensity will be measured using the Visual Analogue Scale (VAS 0-10)
次要结局
- Operative time (minutes)(During Surgery (intraoperative period))
研究者
Asna Ursani
MBBS, FCPS Trainee
Jinnah Postgraduate Medical Centre