Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe pain at 3 and 6 months after surgery.
研究概览
简要总结
The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.
Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.
Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 years and older.
- •Patients with a definite diagnosis of unilateral primary inguinal hernia.
- •Patients and their families were informed about the study protocol and agreed to participate in the study.
排除标准
- •Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
- •Patients with previous history of lower abdominal surgery.
- •Patients with contraindications to anaesthesia.
- •Patients with contraindications to laparoscopic surgery.
- •Failure to follow up patients as scheduled.
- •Patients with abdominal infections.
- •Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.
结局指标
主要结局
Incidence of moderate to severe pain at 3 and 6 months after surgery.
时间窗: 3 and 6 months after surgery.
Visual analogue scale (VAS) was used to score the postoperative pain at 3 and 6 months. The score ranges from 0 (no pain) to 10 (most severe pain).
次要结局
- Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.(3 and 6 months after surgery.)