Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score at 12 months after surgery
研究概览
简要总结
Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain.
This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included.
排除标准
- •Patients with bilateral or sliding inguinal hernia.
- •incarcerated or strangulated hernia
- •recurrent inguinal hernia
- •femoral hernia
- •patients unwilling to participate in the trial.
研究组 & 干预措施
Cyanoacrylate
mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®).
干预措施: Cyanoacryale (Procedure)
Suture
mesh fixation was done with polypropylene 2/0 sutures
干预措施: Suture (Procedure)
结局指标
主要结局
Pain score at 12 months after surgery
时间窗: 12 months after hernia repair
Pain assessed by visual pain scale from 0-10
次要结局
未报告次要终点
研究者
Sameh Emile
lecturer of surgery
Mansoura University