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ID
Source
Brief title
Health condition
Inguinal-related groin pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Rationale: Inguinal-related groin pain is a frequent complaint among athletes. Surgical treatment options include endoscopic totally extraperitoneal (TEP) procedure with mesh. The most frequently used method for surgical treatment is with non-resorbable synthetic mesh. Slowly-resorbable synthetic mesh offers possible advantages over non-resorbable synthetic mesh in the form of a lower incidence of chronic postoperative inguinal pain (CPIP).
Objective: The primary objective is to assess the timespan until resuming full level of sport activity in athletes after TEP surgery with slowly-resorbable TIGR mesh placement for inguinal-related groin pain.
The secondary objectives are to measure the rate of 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.
Study design: Prospective, multicentre, single-arm trial.
Study population: Patients 18 years or older, with inguinal-related groin pain undergoing TEP treatment.
Intervention: Included patients will undergo endoscopic TEP procedure for inguinal-related groin pain. During this procedure a slowly-resorbable TIGR® Matrix mesh will be implanted instead of a non-resorbable polypropylene mesh, which is used in current standard practice.
Main study parameters/endpoints: The primary endpoint is the timespan (in weeks) until resuming full level of sport activity in athletes (in frequency and intensity).
The secondary endpoints will be the rate of CPIP using the Inguinal Pain Questionnaire (IPQ) and the Copenhagen Hip and Groin Outcome Score (HAGOS), recurrences of inguinal-related groin pain, SSI, seroma, hematoma, adhesions, fistula and foreign body reactions.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The potential benefits of this fully resorbable mesh compared to the non-resorbable meshes are a possible reduced risk of seroma formation, infection, persistent pain, CPIP and mesh contractures. A higher recurrence rate may be a potential risk of this product compared to non-resorbable mesh.
Study objective
Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh in patients with inguinal-related groin pain is effective.
Study design
3 weeks, 30 days, 6 weeks and 12 weeks postoperative
Intervention
Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7910 |
| CCMO | NL70724.078.19 |
| OMON | NL-OMON49459 |