Surgical or Conservative Treatment of Sportsman Hernia

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00966589
First received: August 21, 2009
Last updated: March 10, 2010
Last verified: March 2010
  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)

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Decrease of groin pain measured by visual analogue scale (VAS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • laparoscopic surgery in groin pain
  • surgical treatment of sportsman hernia
Active Comparator: surgery
laparoscopic hernioplasty (TEP)
Procedure: laparoscopic hernioplasty (TEP)
Insertion of polypropylene mesh behind pubic bone
Other Names:
  • laparoscopic surgery in groin pain
  • surgical treatment of sportsman hernia

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
Criteria

Inclusion Criteria:

  • severe groin pain lasting > 6 months
  • sportsman hernia

Exclusion Criteria:

  • other diagnosis ruled out by MRI and clinical examination
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00966589

Locations
Finland
Hannu Paajanen
Mikkeli, Finland, 50100
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Hannu EK Paajanen, MD, PhD Central Hospital of Mikkeli, Finland
  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

ClinicalTrials.gov processed this record on October 20, 2014