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Completed
NCT06915155
Swing-Mesh™ Study (SMS).
Conditions: Inguinal Hernia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 323
Sponsor: Swissmed Hospital
Location: Swissmed Hospital Gdansk Gdańsk
Summary
This multicenter, prospective observational study aims to assess the safety and efficacy of the Swing-Mesh™ implant (THT BioScience™, distributed by B. Braun™, France) for laparoscopic-endoscopic inguinal hernia repair using TAPP or TEP techniques. Swing-Mesh™ is a lightweight, macroporous, three-dimensional mesh designed to conform anatomically to the myopectineal orifice without requiring fixation. Eligible adult patients undergoing elective repair will receive the implant. The primary endpoint is hernia recurrence within 6 months. Secondary endpoints include postoperative pain, groin discomfort, and early and late complications. The study will provide clinical evidence regarding the non-inferiority of this spatial, fixation-free mesh compared to standard devices in minimally invasive hernia surgery.
Eligibility Criteria
Inclusion Criteria:
* elective groin hernia repair
* age \> 18 years
* male and female patients can participate
* eligibility for laparoendoscopic repair
* signed written informed consent
Exclusion Criteria:
* age \
Source: ClinicalTrials.gov (NCT06915155). StuddyBuddy aggregates publicly available trial information.