Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- pain relief
研究概览
简要总结
Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis is that laparoscopic technique is less painfull than open surgery for repair of sportsman's hernia.
详细描述
Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia. The results of the operative treatment from single centers are reported to be good to excellent in between 70 - 90% of patients with the most promising results reported using an open minimal repair (OMR) technique. There are no randomized trials comparing open versus laparoscopic techniques regarding time for recovery and relief of pain. The aim of this randomized study is to compare the effectiveness of OMR technique in local or spinal anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free from intractable groin pain during sports activity or daily work four weeks after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males/females professional or non-professional athletes
- •age 18-50 years
- •unilateral or bilateral groin pain lasting > 6 weeks
- •physical examination and MRI indicating sportsman's hernia
- •pain above inguinal ligament in the deep inguinal ring
- •grade I-II edema at pubic symphysis on MRI scan is allowed
排除标准
- •patients not willing to participate
- •inguinal or femoral hernia
- •MRI reveals other major pathology
- •former surgery to the actual groin
- •allergy to polypropylene or other contra-indication to surgery
研究组 & 干预措施
Open repair
Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures
干预措施: open repair (Procedure)
Endoscopic TEP repair
Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh
干预措施: endoscopic TEP repair (Procedure)
结局指标
主要结局
pain relief
时间窗: 4 weeks
The primary endpoint is number of patients having relief of pain during sports activity (VAS scores 0-20, range 0-100) at four weeks after surgery.
次要结局
- time to training(3 months)
研究者
Hannu Paajanen
Professor of Surgery
Kuopio University Hospital