Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Evaluate postoperative complications of pain
研究概览
简要总结
Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.
详细描述
These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 93 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit.
- •They must provide signed written informed consent and agree to comply the study protocol
排除标准
- •Refusal to give informed consent. Refusal to participate giant inguinal hernias
研究组 & 干预措施
Rives technique
Rives technique for primary inguinal hernia
干预措施: Repair for primary inguinal hernia (Procedure)
Lichtenstein repair
Lichtenstein repair for primary inguinal hernia
干预措施: Repair for primary inguinal hernia (Procedure)
结局指标
主要结局
Evaluate postoperative complications of pain
时间窗: 7 days
The patients are clinically reviewed in the office within 7 days of discharge (pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
次要结局
- Evaluate the chronic pain(1 year)
- Evaluate the recurrences(1 year)
研究者
José Jacob Motos Micó
Principal Investigator
Hospital Siberia-Serena