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

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). Resorbable meshes are relatively novel and have not yet been used for this indication in this population. Therefore, currently data on safety, effectiveness, and feasibility of this product in a prophylactic setting should be evaluated. This study aims to evaluate safety, effectiveness, and feasibility, and to provide the first estimates to assess feasibility and necessity of future randomized trials.
Objective: The primary objective of current pilot study is evaluate safety in terms of mesh related complications. Secondary, 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 will be evaluated. However, outcomes will be exploratory and not conclusive.
Study design: Single armed prospective pilot study.
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 safety of placement of the synthetic, slowly-resorbable TIGR® Matrix mesh in patients with inguinal-related groin pain undergoing TEP procedure in terms of intra-operative and postoperative complications.
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.

Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh in patients with inguinal-related groin pain is effective.

3 weeks, 30 days, 6 weeks and 12 weeks postoperatively

Totally extraperitoneal endoscopic reinforcement with slowly-resorbable TIGR Matrix mesh