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CompletedNCT00966589Updated Mar 9, 2017

Surgical or Conservative Treatment of Sportsman Hernia

An interventional study of laparoscopic hernioplasty (TEP) in Groin Pain, sponsored by Kuopio University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-03-09.

Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

  • Groin Pain

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Keywords

  • groin pain
  • sportsman hernia
  • osteitis pubis
  • laparoscopic surgery
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In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • severe groin pain lasting > 6 months
  • sportsman hernia

Exclusion criteria

Exclusion Criteria:

  • other diagnosis ruled out by MRI and clinical examination
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Sham comparator
    conservative treatment

    physiotherapy

    Procedure: laparoscopic hernioplasty (TEP)

  • Active comparator
    surgery

    laparoscopic hernioplasty (TEP)

    Procedure: laparoscopic hernioplasty (TEP)

Interventions

  • Procedurelaparoscopic hernioplasty (TEP)

    Insertion of polypropylene mesh behind pubic bone

    Also known as: laparoscopic surgery in groin pain, surgical treatment of sportsman hernia

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What researchers measure

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

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Study locations

1 site
  • Hannu Paajanen
    Mikkeli, 50100, Finland
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References and documents

Publications

  • Kuikka L, Hermunen H, Paajanen H. Effect of pubic bone marrow edema on recovery from endoscopic surgery for athletic pubalgia. Scand J Med Sci Sports. 2015 Feb;25(1):98-103. doi: 10.1111/sms.12158. Epub 2013 Dec 18. PubMed 24350624 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00966589
Lead sponsor
Kuopio University Hospital
Responsible party
Hannu Paajanen (Doctor, Kuopio University Hospital) — Principal investigator
First posted
Aug 27, 2009
Start date
Jan 2008
Primary completion
Jan 2010
Completion
Feb 2010
Last update
Mar 9, 2017

Study contacts

Hannu EK Paajanen, MD, PhD
study director · Central Hospital of Mikkeli, Finland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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