The objective of this study is to demonstrate the effectivity of TEP repair in the treatment of a sportman's hernia.
ID
Source
Brief title
Condition
- Other condition
- Therapeutic procedures and supportive care NEC
Synonym
Health condition
sportblessures
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The procentual difference in pain reduction between treatment of a sportman's
hernia with TEP repair and diagnostic endoscopy is based on VAS, MSQ and
exercise test scores measured pre- and postoperative and VRCS scores measured
postoperatively.
Secondary outcome
Quality of life: Euroqol, MOS SF-36, time until resumption of normal daily
activities and work measered with a Activities of Daily Life (ADL)
questionnaire.
Time after surgery until resumption of unristrected athletic activity, level of
athletic activity at the time of resumption (Tegner scale of activity), pain
during athletic activity (VAS).
Detection of recurring episodes of groin pain using anamnese and physical
examination at post-operative poli-clinic visits.
Background summary
The sportman's hernia is a common cause of prolonged injury and results in
significant reduction of sporting activity. In professional athletes this
injury is commonly treated with endoscopic inguinal hernia repair via the
totally extra peritoneal method, or TEP repair. Different studies have reported
high rates of return to unrestricted athletic activity after surgery. However,
the effect of a TEP repair has never been researched in a prospective and
randomised controlled trial. In this study patients are randomized in a
intervention group for TEP repair or in a control group for diagnostic
endoscopy of the groin region.
Study objective
The objective of this study is to demonstrate the effectivity of TEP repair in
the treatment of a sportman's hernia.
Study design
In a prospective, single-blinded, controlled trial, sporters clinically
diagnosed with sportman's hernia are randomised for TEP repair or diagnostic
endoscopy.
Intervention
The intervention consists of TEP repair compared to diagnostic endoscopy.
Study burden and risks
The risks of this study are the complications which may occur during surgery,
as consequence of the surgery itself or as as consequence of general
anaesthesia. The benefit of participation in the study is a speedy recovery and
resumption of sporting activity as a result of surgery.
Dr. Molewaterplein 50
3000 DR Rotterdam
Nederland
Dr. Molewaterplein 50
3000 DR Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Male subjects, age 18-50 years;
Undiagnosed groin pain for at least 3 months;
Pain in the groin region, worsening during athletic activity;
Signed informed consent.
Exclusion criteria
Professional athletes;
Bilateral groin pain;
Clinically recognizable inguinal hernia;
Patients with a history of scrotal hernia, inguinal hernia repair, prostatectomy, Pfannenstiehl's-incision, preperitoneal surgery or abdominal bladder surgery;
Patients with a contra-indication for endoscopy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12636.078.06 |