Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Postoperative administration of analgesics
研究概览
简要总结
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.
详细描述
Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.
The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open inguinal hernioplasty in patients over 18 years old
排除标准
- •Patient refusal
- •Laparoscopic surgery
- •Reintervention surgery
- •Urgent surgery
- •Cyanoacrylate allergy
- •Administration of intraoperative local anesthetics
- •Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.
结局指标
主要结局
Postoperative administration of analgesics
时间窗: 6 months
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Postoperative pain assessed by visual numeric scale
时间窗: 6 months
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
次要结局
- Hernia recurrence(6 months)
- Hematoma(1 month)
研究者
Justyna Drewniak Jakubowska
Surgeon
Hospital Universitario de Móstoles