Surgical or Conservative Treatment of Sportsman Hernia

NCT ID: NCT00966589

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Groin Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conservative treatment

physiotherapy

Group Type SHAM_COMPARATOR

laparoscopic hernioplasty (TEP)

Intervention Type PROCEDURE

Insertion of polypropylene mesh behind pubic bone

surgery

laparoscopic hernioplasty (TEP)

Group Type ACTIVE_COMPARATOR

laparoscopic hernioplasty (TEP)

Intervention Type PROCEDURE

Insertion of polypropylene mesh behind pubic bone

Interventions

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laparoscopic hernioplasty (TEP)

Insertion of polypropylene mesh behind pubic bone

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic surgery in groin pain surgical treatment of sportsman hernia

Eligibility Criteria

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Inclusion Criteria

* severe groin pain lasting \> 6 months
* sportsman hernia

Exclusion Criteria

* other diagnosis ruled out by MRI and clinical examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hannu Paajanen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannu EK Paajanen, MD, PhD

Role: STUDY_DIRECTOR

Central Hospital of Mikkeli, Finland

Locations

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Hannu Paajanen

Mikkeli, Mikkeli, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 24350624 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/sites/entrez

PMID: 15472551 \[PubMed - indexed for MEDLINE\]

Other Identifiers

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KUH5204519

Identifier Type: -

Identifier Source: org_study_id

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