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SloWly-resorbable TIGR® Matrix mesh For totally extraperitoneal (TEP) endoscopic reinforcemenT of inguinal-related groin pain, a pilot study

SloWly-resorbable TIGR® Matrix mesh For totally extraperitoneal (TEP) endoscopic reinforcemenT of inguinal-related groin pain, a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22732
Enrollment
45
Registered
2021-04-06
Start date
2021-06-30
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Inguinal-related groin pain

Interventions

Sponsors

Novus Scientific AB, Uppsala Sweden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Athletes with inguinal-related groin pain, as defined in the Doha agreement (6) i.e. “pain location in the inguinal canal region and tenderness of the inguinal canal”, that was not sufficient resolved with standard conservative treatment of at least 2 months, undergoing elective TEP procedure. - Frequency sports activity >2 / week. - Age = 18 years. - Signed informed consent by patient.

Exclusion criteria

Exclusion criteria: - Inguinal or femoral hernia. - Previous inguinal hernia surgery. - Patient with clearly more complaints due to an adductor-related groin pain instead of the inguinal-related groin pain as examined by clinician after 2 months of conservative treatment. - Existing CPIP. - Nerve entrapment as assessed by clinician. - Referred spinal pain. - Apophysitis or avulsion fracture of pelvic bone in the groin area. - Disorders to the hip joint or bursitis. - Intra-abdominal disorders including urologic, gynecologic or bowel pathology.

Design outcomes

Primary

MeasureTime frame
The primary objective of current pilot study is evaluate safety in terms of mesh related complications

Secondary

MeasureTime frame
The efficacy of slowly-resorbable TIGR mesh by measuring pain reduction during exercise on the numeric rating scale, sport resumption, physical functioning, CPIP and recurrences of inguinal-related groin pain

Contacts

Public ContactFloris den Hartog

Erasmus MC

f.denhartog@erasmusmc.nl+31 10 704 36 84

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)