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Inguinal pain in sportsmen


- candidate number16838
- NTR NumberNTR4568
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2014
- Secondary IDs
- Public TitleInguinal pain in sportsmen
- Scientific TitleInguinal pain in sportsmen
- ACRONYM
- hypothesisTreatment with the TEP technique reduces pain in athletes with (chronic) inguinal pain.
- Healt Condition(s) or Problem(s) studiedGroin pain, Inguinal Pain, Athletes
- Inclusion criteria1. Age > 18 years
2. No previous inguinal surgery
3. Inguinal pain during / after playing sports
4. Pain exists longer than 3 months and in professional sporters longer than 6 weeks
5. The patient does not benefit from physiotherapy
- Exclusion criteria1. Patients younger than 18 years
2. Previous inguinal surgery
3. Prooved other cause of inguinal pain
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2016
- Target number of participants100
- Interventions- Inguinal ultrasound
- X-pelvis/hip
- MRI
- Totally extraperitoneal patch (TEP) plasty
- Primary outcome- Pain score (NRS, numerous rating score)
- Secondary outcomeSecondary outcomes are resumption of sport (in frequency and intensity) measured preoperative and 1, 2, 3, 4, 5, 6 weeks and 3 months postoperative. Symptoms, pain, restrictions of daily living, restrictions in sports and groin-related Quality of Life is measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) preoperative, 1 week, 6 weeks and 3 months postoperative.
- Timepoints- Preoperative
- 1, 2, 3, 4, 5 and 6 weeks
- 3 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. C.E.H. Voorbrood
- CONTACT for SCIENTIFIC QUERIESDrs. J.P.J. Burgmans
- Sponsor/Initiator Diakonessenhuis Utrecht, The Netherlands., KNVB Sportmedisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryInguinal disruption is a condition of chronic inguinal pain in athletes, with an incidence of 0.5-6.2% causing many athletes being affected. Inguinal disruption is defined as groin pain where no obvious other pathology exists to explain the symptoms. Appropriate treatment is important for fast resumption of sport activities of the athlete and is aimed toward it specific pathology.
Management of inguinal disruption may start with conservative options (rehabilitation programs, physiotherapy). In case of on-going inguinal pain, surgical repair can be undertaken. The Totally Extraperitoneal Patch (TEP) technique ensures a comprehensive view to the hernia floor and its insertion area. Moreover, the preperitoneal approach is associated with less chronic postoperative pain and a fast recovery to daily activities.
Endoscopic TEP hernia repair with implantation of a lightweight mesh could therefore, be an appealing technique in athletes with inguinal disruption.

This study will provide a complete assessment of the inguinal area in athletes with chronic inguinal pain before and after treatment by the Totally Extraperitoneal Patch (TEP) technique. The study population are patients older than 18 years with inguinal pain during or after playing sports longer than 3 months without previous inguinal surgery and without benefits from physiotherapy.

The aim of this study is to analyze whether treatment with the Totally Extraperitoneal Prostetic technique (TEP) reduce inguinal pain in athletes (“inguinal disruption”)
- Main changes (audit trail)
- RECORD13-mrt-2014 - 15-okt-2014


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