Chronic Painsports herniaNCT01876342
TEP Versus Open Repair of Sportsman's Hernia
A study testing open repair and endoscopic TEP repair in people with Chronic Pain and Bone Marrow Oedema, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Pain, Bone Marrow Oedema
- What is being tested?
- open repair and endoscopic TEP repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2013to Dec 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- males/females professional or non-professional athletes
- age 18-50 years
- unilateral or bilateral groin pain lasting > 6 weeks
- physical examination and MRI indicating sportsman's hernia
- pain above inguinal ligament in the deep inguinal ring
- grade I-II edema at pubic symphysis on MRI scan is allowed
Who cannot join
- patients not willing to participate
- inguinal or femoral hernia
- MRI reveals other major pathology
- former surgery to the actual groin
- allergy to polypropylene or other contra-indication to surgery
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Hannu Paajanen
Kuopio, 70600
Hannu EK Paajanen, MD, PhD, +358-40-5263101 ext. +358, hannu.paajanen@kuh.fi
Hannu EK Paajanen, MD, PhD
About this study
Official title: Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis is that laparoscopic technique is less painfull than open surgery for repair of sportsman's hernia.
Read the detailed description
Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia. The results of the operative treatment from single centers are reported to be good to excellent in between 70 - 90% of patients with the most promising results reported using an open minimal repair (OMR) technique. There are no randomized trials comparing open versus laparoscopic techniques regarding time for recovery and relief of pain. The aim of this randomized study is to compare the effectiveness of OMR technique in local or spinal anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free from intractable groin pain during sports activity or daily work four weeks after surgery.
- Conditions
- Chronic Pain, Bone Marrow Oedema
- Being tested
- open repair, endoscopic TEP repair
- Keywords
- sports hernia, sportsman's hernia, chronic groin pain, open minimal repair, totally extraperitoneal endoscopic technique
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open repairProcedure or surgery
2-0 sutures
endoscopic TEP repairProcedure or surgery
mesh
| Study group | Role | What they receive |
|---|---|---|
| Open repair | Experimental | Open minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures Receives: Procedure: open repair |
| Endoscopic TEP repair | Active comparator | Totally Endoscopic extraperitoneal repair (TEP)using lightweight mesh Receives: Procedure: endoscopic TEP repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
The primary endpoint is number of patients having relief of pain during sports activity (VAS scores 0-20, range 0-100) at four weeks after surgery.
Measured: 4 weeks
Secondary outcomes (1)
time to training
Secondary end-points are time to resume low-level training and full-level training/competing, complications, one year follow-up and costs of surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
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 Chronic 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
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 Paajanen, MD, PhD, Principal investigator, Kuopio University Hospital, Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876342
- Sponsor's protocol ID
- 27/2013
- Other IDs
- 27/2013
- Acronym
- sports hernia
- Status last verified
- Aug 2018
- First submitted
- 9 Jun 2013
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Paajanen H, Brinck T, Hermunen H, Airo I. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia). Surgery. 2011 Jul;150(1):99-107. doi: 10.1016/j.surg.2011.02.016. Epub 2011 May 5.
PubMed 21549403
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total ExtraPeritoneal (TEP) Versus Open Minimal Suture Repair for Treatment of Sportsman's Hernia/Athletic Pubalgia: A Randomized Multi-center Trial
- ClinicalTrials.gov ID
- NCT01876342
- Acronym / sponsor ID
- sports hernia / 27/2013
- Conditions
- Chronic Pain, Bone Marrow Oedema
- Keywords
- sports hernia, sportsman's hernia, chronic groin pain, open minimal repair, totally extraperitoneal endoscopic technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jun 2013 (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.
Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis is that laparoscopic technique is less painfull than open surgery for repair of sportsman's hernia.
Detailed description
Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia. The results of the operative treatment from single centers are reported to be good to excellent in between 70 - 90% of patients with the most promising results reported using an open minimal repair (OMR) technique. There are no randomized trials comparing open versus laparoscopic techniques regarding time for recovery and relief of pain. The aim of this randomized study is to compare the effectiveness of OMR technique in local or spinal anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free from intractable groin pain during sports activity or daily work four weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open repair | Experimental | Procedure: open repairOpen minimal repair (OMR) of Sportsman's hernia using 2-0 continuous sutures |
| Endoscopic TEP repair | Active comparator | Procedure: endoscopic TEP repairTotally Endoscopic extraperitoneal repair (TEP)using lightweight mesh |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- males/females professional or non-professional athletes
- age 18-50 years
- unilateral or bilateral groin pain lasting > 6 weeks
- physical examination and MRI indicating sportsman's hernia
- pain above inguinal ligament in the deep inguinal ring
Key exclusion criteria (5 listed)
- patients not willing to participate
- inguinal or femoral hernia
- MRI reveals other major pathology
- former surgery to the actual groin
- allergy to polypropylene or other contra-indication to surgery
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 |
|---|---|---|
| open repair2-0 sutures | Procedure or surgery | Open repair |
| endoscopic TEP repairmesh | Procedure or surgery | Endoscopic TEP repair |
Primary outcome
pain relief
Time frame: 4 weeks
The primary endpoint is number of patients having relief of pain during sports activity (VAS scores 0-20, range 0-100) at four weeks after surgery.
1 secondary outcome
time to training
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 21549403Paajanen H, Brinck T, Hermunen H, Airo I. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia). Surgery. 2011 Jul;150(1):99-107. doi: 10.1016/j.surg.2011.02.016. Epub 2011 May 5.
- Individual participant dataSharing planned: Undecided
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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 Paajanen, MD, PhD principal investigator
Kuopio University Hospital, Kuopio, 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 open repair and endoscopic TEP repair in people with Chronic Pain and Bone Marrow Oedema, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannu EK Paajanen, MD, PhD (+358-40-5263101 ext. +358, hannu.paajanen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: 4 weeks). 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 NCT01876342, 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 14 Aug 2018.