Surgical or Conservative Treatment of Sportsman Hernia
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Purpose
Five to ten percent of athletes and physical active adults are suffering chronic groin pain. The most common diagnoses are adductor tendinitis, sportsman hernia and osteitis pubis. Sportsman hernia is not a real hernia in the groin, but overuse injury of the groin muscles and tendons. No evidence-based treatment of this disabling condition has been found so far. Experimental surgical treatments are based on various hernioplasties. Laparoscopic extraperitoneal hernioplasty (TEP) is a mini-invasive and effective method to heal sportsman hernia in non-randomized cohorts.
| Condition | Intervention | Phase |
|---|---|---|
|
Groin Pain |
Procedure: laparoscopic hernioplasty (TEP) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP) |
- Decrease of groin pain measured by visual analogue scale (VAS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Return to sport activities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: conservative treatment
rest, physical treatment, corticosteroid injections, anti-inflammatory analgesics
|
Procedure: laparoscopic hernioplasty (TEP)
Insertion of polypropylene mesh behind pubic bone
Other Names:
|
|
Active Comparator: surgery
laparoscopic hernioplasty (TEP)
|
Procedure: laparoscopic hernioplasty (TEP)
Insertion of polypropylene mesh behind pubic bone
Other Names:
|
Detailed Description:
This prospective randomized study investigates the effect of active conservative treatment (rest, physical treatment, corticosteroid injections, anti-inflammatory analgesics) versus surgery (laparoscopic TEP) on the healing of sportsman hernia. Diagnosis of sportsman hernia is always based on careful clinical examination and magnetic resonance imaging. 25 patients with sportsman hernia are randomized into conservative treatment and 25 patients in surgery. The duration of follow-up is 1 year. The main end-point of treatments is disappearing of chronic groin pain (visual analogue scale, entering to sports).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- severe groin pain lasting > 6 months
- sportsman hernia
Exclusion Criteria:
- other diagnosis ruled out by MRI and clinical examination
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Hannu Paajanen, Central Hospital of Mikkeli, Finland |
| ClinicalTrials.gov Identifier: | NCT00966589 History of Changes |
| Other Study ID Numbers: | KUH5204519 |
| Study First Received: | August 21, 2009 |
| Last Updated: | March 10, 2010 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Kuopio University Hospital:
|
groin pain sportsman hernia osteitis pubis laparoscopic surgery |
Additional relevant MeSH terms:
|
Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013