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Surgical or Conservative Treatment of Sportsman Hernia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966589
First Posted: August 27, 2009
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital
  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
Groin Pain Procedure: laparoscopic hernioplasty (TEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Hannu Paajanen, Kuopio University Hospital:

Primary Outcome Measures:
  • Decrease of groin pain measured by visual analogue scale (VAS) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Return to sport activities [ Time Frame: 1 year ]

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
Sham Comparator: conservative treatment
physiotherapy
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannu Paajanen, Doctor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00966589     History of Changes
Other Study ID Numbers: KUH5204519
First Submitted: August 21, 2009
First Posted: August 27, 2009
Last Update Posted: March 9, 2017
Last Verified: March 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hannu Paajanen, Kuopio University Hospital:
groin pain
sportsman hernia
osteitis pubis
laparoscopic surgery

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical