Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- pain one month after surgery
研究概览
简要总结
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.
详细描述
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:
Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.
The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
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
- Double (Participant, Outcomes Assessor)
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
- •adult patients diagnosed with uncomplicated primary inguinal hernia
- •mentally healthy patients
- •patients without preoperative groin pain
- •patients eligible for outpatient surgery
排除标准
- •patients with different surgical diagnosis
研究组 & 干预措施
Elliptical domed mesh technique
84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
干预措施: Elliptical domed mesh technique (Procedure)
Lichtenstein technique
84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
干预措施: Elliptical domed mesh technique (Procedure)
结局指标
主要结局
pain one month after surgery
时间窗: one month
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain three months after surgery
时间窗: three months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain six months after surgery
时间窗: six months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
次要结局
- dysesthesia one month after surgery(one month)
- dysesthesia three months after surgery(three months)
- dysesthesia six months after surgery(six months)