Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Carolinas Comfort Scale values
研究概览
简要总结
At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical or/and radiological diagnosed primary inguinal hernia
- •TEP or TAPP surgical methods
排除标准
- •Recurrent hernias
- •Patients with previous groin operations on same side
- •Pregnant women
- •Patients who did not accept to participate in the study
- •ASA score of 3 or higher,
结局指标
主要结局
Carolinas Comfort Scale values
时间窗: 6 month
Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
Recurrence rates
时间窗: 6 month
Differences in recurrence rates in patients who use whole meshes and those who use split meshes.
次要结局
- Recurrence rates(6 month)
研究者
Erol Aydın
General Surgeon
Istanbul Training and Research Hospital