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Sportsmen, TEP repair versus Endoscopy trial

Sportsmen, TEP repair versus Endoscopy trial - SporTEr trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29790
Enrollment
80
Registered
2006-07-13
Start date
2006-01-09
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sportblessures dilated internal ring sportman's hernia

Interventions

The intervention consists of TEP repair compared to diagnostic endoscopy.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)