Surgical or Conservative Treatment of Sportsman Hernia

Study Overview
=================
Brief Summary
-----------------
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.

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).

Official Title
-----------------
Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP)

Conditions
-----------------
Groin Pain

Intervention / Treatment
-----------------
* Procedure: laparoscopic hernioplasty (TEP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe groin pain lasting > 6 months sportsman hernia Exclusion Criteria: other diagnosis ruled out by MRI and clinical examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: conservative treatment<br>physiotherapy | Procedure: laparoscopic hernioplasty (TEP)<br>* Insertion of polypropylene mesh behind pubic bone<br>* Other names: surgical treatment of sportsman hernia;|
| Active Comparator: surgery<br>laparoscopic hernioplasty (TEP) | Procedure: laparoscopic hernioplasty (TEP)<br>* Insertion of polypropylene mesh behind pubic bone<br>* Other names: surgical treatment of sportsman hernia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of groin pain measured by visual analogue scale (VAS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to sport activities |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
groin pain, sportsman hernia, osteitis pubis, laparoscopic surgery