Randomized Control Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP (Total Extraperitoneal) Repair for Groin Hernias
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- acute post-operative pain with VAS
研究概览
简要总结
This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.
详细描述
consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia
排除标准
- •Patient preference for either fixation technique, refusal to participate, previous major lower abdominal surgery, concomitant surgical procedures other than hernia repair, and history of allergy to Histoacryl.
结局指标
主要结局
acute post-operative pain with VAS
时间窗: 6 hours after OP
次要结局
- Chronic pain VAS pain scale(6 months after OP)
- Questionnaire of complications(6 months after OP)
研究者
Yao-Chou Tsai, Principle investigator
Principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation