Surgical or Conservative Treatment of Sportsman Hernia
Primary Purpose
Groin Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
laparoscopic hernioplasty (TEP)
Sponsored by
About this trial
This is an interventional treatment trial for Groin Pain focused on measuring groin pain, sportsman hernia, osteitis pubis, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- severe groin pain lasting > 6 months
- sportsman hernia
Exclusion Criteria:
- other diagnosis ruled out by MRI and clinical examination
Sites / Locations
- Hannu Paajanen
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
conservative treatment
surgery
Arm Description
physiotherapy
laparoscopic hernioplasty (TEP)
Outcomes
Primary Outcome Measures
Decrease of groin pain measured by visual analogue scale (VAS)
Secondary Outcome Measures
Return to sport activities
Full Information
NCT ID
NCT00966589
First Posted
August 21, 2009
Last Updated
March 7, 2017
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00966589
Brief Title
Surgical or Conservative Treatment of Sportsman Hernia
Official Title
Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Groin Pain
Keywords
groin pain, sportsman hernia, osteitis pubis, laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conservative treatment
Arm Type
Sham Comparator
Arm Description
physiotherapy
Arm Title
surgery
Arm Type
Active Comparator
Arm Description
laparoscopic hernioplasty (TEP)
Intervention Type
Procedure
Intervention Name(s)
laparoscopic hernioplasty (TEP)
Other Intervention Name(s)
laparoscopic surgery in groin pain, surgical treatment of sportsman hernia
Intervention Description
Insertion of polypropylene mesh behind pubic bone
Primary Outcome Measure Information:
Title
Decrease of groin pain measured by visual analogue scale (VAS)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Return to sport activities
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe groin pain lasting > 6 months
sportsman hernia
Exclusion Criteria:
other diagnosis ruled out by MRI and clinical examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Organizational Affiliation
Central Hospital of Mikkeli, Finland
Official's Role
Study Director
Facility Information:
Facility Name
Hannu Paajanen
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24350624
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/sites/entrez
Description
PMID: 15472551 [PubMed - indexed for MEDLINE]
Learn more about this trial
Surgical or Conservative Treatment of Sportsman Hernia
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