Groin PainNCT00966589
Surgical or Conservative Treatment of Sportsman Hernia
A study testing laparoscopic hernioplasty (TEP) in people with Groin Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Groin Pain
- What is being tested?
- laparoscopic hernioplasty (TEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- severe groin pain lasting > 6 months
- sportsman hernia
Who cannot join
- other diagnosis ruled out by MRI and clinical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP)
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).
- Conditions
- Groin Pain
- Being tested
- laparoscopic hernioplasty (TEP)
- Keywords
- groin pain, sportsman hernia, osteitis pubis, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hernioplasty (TEP)Procedure or surgery
Also called laparoscopic surgery in groin pain, surgical treatment of sportsman hernia
Insertion of polypropylene mesh behind pubic bone
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Sham comparator | physiotherapy Receives: Procedure: laparoscopic hernioplasty (TEP) |
| surgery | Active comparator | laparoscopic hernioplasty (TEP) Receives: Procedure: laparoscopic hernioplasty (TEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of groin pain measured by visual analogue scale (VAS)
Measured: 1 year
Secondary outcomes (1)
Return to sport activities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Groin PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannu Paajanen, Kuopio University Hospital
- Investigators
- Hannu EK Paajanen, MD, PhD, Study director, Central Hospital of Mikkeli, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966589
- Sponsor's protocol ID
- KUH5204519
- Status last verified
- Mar 2010
- First submitted
- 21 Aug 2009
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP)
- ClinicalTrials.gov ID
- NCT00966589
- Acronym / sponsor ID
- KUH5204519
- Conditions
- Groin Pain
- Keywords
- groin pain, sportsman hernia, osteitis pubis, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | Sham comparator | Procedure: laparoscopic hernioplasty (TEP)physiotherapy |
| surgery | Active comparator | Procedure: laparoscopic hernioplasty (TEP)laparoscopic hernioplasty (TEP) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- severe groin pain lasting > 6 months
- sportsman hernia
Key exclusion criteria (1 listed)
- other diagnosis ruled out by MRI and clinical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic hernioplasty (TEP)Also: laparoscopic surgery in groin pain, surgical treatment of sportsman herniaInsertion of polypropylene mesh behind pubic bone | Procedure or surgery | conservative treatment, surgery |
Primary outcome
Decrease of groin pain measured by visual analogue scale (VAS)
Time frame: 1 year
1 secondary outcome
Return to sport activities
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 24350624Kuikka 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: 15472551 \[PubMed - indexed for MEDLINE\]Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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An Exercise-based Rehabilitation Program for a Recreational Long-distance Runner With Long-standing Groin Pain
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Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
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Effect of Anterior Iliac Block on Postoperative Analgesia and Patient Satisfaction in Inguinal Hernia Repair Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu EK Paajanen, MD, PhD study director
Central Hospital of Mikkeli, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic hernioplasty (TEP) in people with Groin Pain, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of groin pain measured by visual analogue scale (VAS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.