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Slowly-resorbable TIGR® Matrix mesh for totally extraperitoneal (TEP) endoscopic reinforcement of inguinal-related groin pain.

Slowly-resorbable TIGR® Matrix mesh for totally extraperitoneal (TEP) endoscopic reinforcement of inguinal-related groin pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22090
Enrollment
40
Registered
2019-07-29
Start date
2019-10-01
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 i.e. “pain location in the inguinal canal region and tenderness of the inguinal canal”, that was not resolved with standard conservative treatment of at least 2 months, undergoing elective TEP procedure. - 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 is to determine the timespan until resuming full level of sport activity in athletes after TEP surgery with slowly-resorbable TIGR® mesh placement.

Secondary

MeasureTime frame
The secondary objectives are to measure the rate of chronic postoperative inguinal pain (CPIP), recurrences of inguinal-related groin pain and surgical site occurrences (SSO), defined as surgical site infection (SSI), seroma, hematoma, adhesions, fistula and foreign body reactions.

Contacts

Public ContactGijs de Smet

Erasmus MC, University Medical Center

g.h.j.desmet@erasmusmc.nl0107043683

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)