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| ID | Type | Description | Link |
|---|---|---|---|
| 27/2013 | Registry Identifier | 27/2013 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open repair | Experimental | Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures |
|
| Endoscopic TEP repair | Active Comparator | Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open repair | Procedure | 2-0 sutures |
| |
| endoscopic TEP repair |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannu EK Paajanen, MD, PhD | Contact | +358-40-5263101 | +358 | hannu.paajanen@kuh.fi |
| Name | Affiliation | Role |
|---|---|---|
| Hannu Paajanen, MD, PhD | Kuopio University Hospital, Kuopio, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannu Paajanen | Recruiting | Kuopio | 70600 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21549403 | Background | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
mesh |
|