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Completed

NCT Number: NCT00966589

Surgical or Conservative Treatment of Sportsman Hernia

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannu Paajanen

Mikkeli, 50100, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe groin pain lasting > 6 months
  • sportsman hernia

Exclusion criteria

  • other diagnosis ruled out by MRI and clinical examination

Treatment and study plan

laparoscopic hernioplasty (TEP)

Procedure

Insertion of polypropylene mesh behind pubic bone

Other names: laparoscopic surgery in groin pain, surgical treatment of sportsman hernia

Primary outcomes

  1. Decrease of groin pain measured by visual analogue scale (VAS)

    Time frame: 1 year

Secondary outcomes

  1. Return to sport activities

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2009
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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