Assessing the Swing-Mesh™ implant for inguinal hernia repair
Safety and Efficacy of the Swing-Mesh™ Implant (THT BioScience™, B. Braun™, France) in Laparoscopic-endoscopic Inguinal Hernia Repair - a Multicenter, Cohort, Prospective Observational Study.
This study is testing a new type of mesh implant for repairing inguinal hernias to see if it works as well as the standard options for adults having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swissmed Hospital Academic / other |
| Locations | 2 sites (Gdańsk and 1 other locations) |
| Trial ID | NCT06915155 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational study evaluates the safety and efficacy of the Swing-Mesh™ implant for laparoscopic-endoscopic inguinal hernia repair using TAPP or TEP techniques. The study aims to provide clinical evidence regarding the non-inferiority of this lightweight, macroporous, three-dimensional mesh compared to standard devices. Eligible adult patients undergoing elective repair will receive the implant, and the primary endpoint is hernia recurrence within 6 months, with secondary endpoints including postoperative pain and complications. The study will document surgical steps and follow-up outcomes to assess the mesh's performance in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years undergoing elective laparoscopic inguinal hernia repair.
Not a fit: Patients with emergency surgeries, recurrent hernias, or specific large scrotal hernias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in inguinal hernia repair with reduced recurrence rates and postoperative discomfort.
How similar studies have performed: Other studies have shown promise with similar three-dimensional mesh approaches, but this specific implant's efficacy is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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 \<18 years * emergency surgery (incarcerated hernia) * contaminated surgical field * recurrent hernia * extremely large scrotal hernias with the need of other abdominal compartment syndrome (ACS) preventive procedures (botulin injection, bowel resection, preoperative progressive pneumoperitoneum - PPP) * M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery
Where this trial is running
Gdańsk and 1 other locations
- Swissmed Hospital — Gdańsk, Poland (Recruiting)
- Swissmed Hospital — Gdańsk, Poland (Recruiting)
Study contacts
- Study coordinator: Mateusz Zamkowski, MD, PhD
- Email: zamek@gumed.edu.pl
- Phone: 504236036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.