NCT00966589

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

August 21, 2009

Last Update Submit

March 7, 2017

Conditions

Groin Pain

Keywords

groin painsportsman herniaosteitis pubislaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

  • Return to sport activities

    1 year

Study Arms (2)

conservative treatment

SHAM COMPARATOR

physiotherapy

Procedure: laparoscopic hernioplasty (TEP)

surgery

ACTIVE COMPARATOR

laparoscopic hernioplasty (TEP)

Procedure: laparoscopic hernioplasty (TEP)

Interventions

laparoscopic hernioplasty (TEP)PROCEDURE

Insertion of polypropylene mesh behind pubic bone

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • other diagnosis ruled out by MRI and clinical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannu Paajanen

Mikkeli, Mikkeli, 50100, Finland

Location

Related Publications (1)

  • 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.

    PMID: 24350624DERIVED

Related Links

MeSH Terms

Interventions

tetraethylpyrazineLaparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hannu EK Paajanen, MD, PhD

    Central Hospital of Mikkeli, Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 27, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

March 9, 2017

Record last verified: 2010-03

Locations

FI(1)