TEP Versus Open Repair of Sportsman's Hernia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial

Conditions
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Chronic Pain, Bone Marrow Oedema

Intervention / Treatment
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* Procedure: open repair
* Procedure: endoscopic TEP repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open repair<br>Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures | Procedure: open repair<br>* 2-0 sutures<br>|
| Active Comparator: Endoscopic TEP repair<br>Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh | Procedure: endoscopic TEP repair<br>* mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sports hernia, sportsman's hernia, chronic groin pain, open minimal repair, totally extraperitoneal endoscopic technique