Sportsman's Groin HerniaNCT01752387
The Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players
An observational study of Sportsman's Groin Hernia, run by HaEmek Medical Center, Israel.
Trial summary
The purpose of this study is to compare the surgical treatment for sportsman's hernia in our department to the current literature. Our hypothesis is that combined solution for the two major problems that cause pain in this syndrome - repair the weakness in the posterior wall of the inguinal canal with "tension free"… Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sportsman's Groin Hernia
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Aug 2012
- Phase
- Observational
- 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: soccer players with groin pain
Who may be able to join
- Soccer players who reffered to our clinic
- soccer players diagnosed with sportsman's hernia
- Failure of conservative treatment
- Underwent conventional surgery for sportsman's hernia in our department
- Completed the follow-up in our clinic
- age : 14-40
- male and female
Who cannot join
- soccer players who were diagnosed of had there surgery in other places
- soccer players who recover after conservative treatment
About this study
Official title: A Study, Based on Medical Record and Questionnaire, Investigate the Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players -Results of the Follow-up in Our Department and a Comparison the Medical Literature
The purpose of this study is to compare the surgical treatment for sportsman's hernia in our department to the current literature. Our hypothesis is that combined solution for the two major problems that cause pain in this syndrome - repair the weakness in the posterior wall of the inguinal canal with "tension free" technique (mesh repair) and reducing the muscle strain on the abdominal wall by cutting, partially, the tendon of the external oblique muscle, will shorten the time to return to full physical activity in soccer players.
- Conditions
- Sportsman's Groin Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
time to return to full physical activity
Measured: 2 month
Secondary outcomes (1)
pain after the surgery
Measured: 1 week, 2 weeks and 4-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJun 2006
- Primary completionJan 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sportsman's Groin HerniaStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752387
- Sponsor's protocol ID
- EMC-0133-12
- Status last verified
- Nov 2012
- First submitted
- 2 Dec 2012
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study, Based on Medical Record and Questionnaire, Investigate the Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players -Results of the Follow-up in Our Department and a Comparison the Medical Literature
- ClinicalTrials.gov ID
- NCT01752387
- Acronym / sponsor ID
- EMC-0133-12
- Conditions
- Sportsman's Groin Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Dec 2012 (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.
The purpose of this study is to compare the surgical treatment for sportsman's hernia in our department to the current literature. Our hypothesis is that combined solution for the two major problems that cause pain in this syndrome - repair the weakness in the posterior wall of the inguinal canal with "tension free" technique (mesh repair) and reducing the muscle strain on the abdominal wall by cutting, partially, the tendon of the external oblique muscle, will shorten the time to return to full physical activity in soccer players.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- soccer players with groin pain
Key inclusion criteria (7 listed)
- Soccer players who reffered to our clinic
- soccer players diagnosed with sportsman's hernia
- Failure of conservative treatment
- Underwent conventional surgery for sportsman's hernia in our department
- Completed the follow-up in our clinic
Key exclusion criteria (2 listed)
- soccer players who were diagnosed of had there surgery in other places
- soccer players who recover after conservative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to return to full physical activity
Time frame: 2 month
1 secondary outcome
pain after the surgery
Time frame: 1 week, 2 weeks and 4-6 month
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 12 Jun 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sportsman's Groin Hernia, run by HaEmek Medical Center, Israel.
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 7 inclusion and 2 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 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
time to return to full physical activity (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2015.