Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh in patients with inguinal-related groin pain is effective.
ID
Bron
Verkorte titel
Aandoening
Inguinal-related groin pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh in patients with inguinal-related groin pain is effective.
Onderzoeksopzet
3 weeks, 30 days, 6 weeks and 12 weeks postoperative
Onderzoeksproduct en/of interventie
Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7910 |
| CCMO | NL70724.078.19 |
| OMON | NL-OMON49459 |