Status:
ACTIVE_NOT_RECRUITING
Swing-Mesh™ Study (SMS).
Lead Sponsor:
Swissmed Hospital
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18+ years
Brief 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 ingu...
Detailed Description
Laparoscopic techniques such as TAPP and TEP are currently recommended as the standard approach for inguinal hernia repair due to faster recovery, reduced postoperative pain, and lower complication ra...
Eligibility Criteria
Inclusion
- elective groin hernia repair
- age \> 18 years
- male and female patients can participate
- eligibility for laparoendoscopic repair
- signed written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06915155
Start Date
April 7 2025
End Date
August 30 2026
Last Update
December 5 2025
Active Locations (2)
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1
Swissmed Hospital
Gdansk, Gdańsk, Poland, 80-215
2
Swissmed Hospital
Gdansk, Poland, 80-280