Chronic Pain Clinical Trial
— sports herniaOfficial title:
Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Hannu Paajanen | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital |
Finland,
Paajanen H, Brinck T, Hermunen H, Airo I. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia). Surgery. 2011 Jul;150(1):99-107. doi: 10.1016/j.surg.2011.02.016. Epub 2011 May 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain relief | 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. | 4 weeks | |
Secondary | time to training | Secondary end-points are time to resume low-level training and full-level training/competing, complications, one year follow-up and costs of surgery | 3 months |
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