Surgical or Conservative Treatment of Sportsman Hernia

Groin Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966589
• Other study ID #: KUH5204519
• Status: Completed
• Phase: N/A
• First received: August 21, 2009
• Last updated: March 7, 2017
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• severe groin pain lasting > 6 months

• sportsman hernia

Exclusion Criteria:

• other diagnosis ruled out by MRI and clinical examination

Related Conditions & MeSH terms

• Groin Pain
• Hernia

Intervention

Procedure:
• laparoscopic hernioplasty (TEP)
Insertion of polypropylene mesh behind pubic bone

Locations

Country	Name	City	State
Finland	Hannu Paajanen	Mikkeli

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of groin pain measured by visual analogue scale (VAS)		1 year
Secondary	Return to sport activities		1 year

External Links

•   PMID: 15472551 [PubMed - indexed for MEDLINE]