Clinical trial NCT06915155: Swing-Mesh™ Study (SMS).
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inguinal Hernia
Keywords: Mesh
Groin Hernia
Hernia
TAPP
TEP
Inguinal Hernia
Minimally Invasive Surgery
Laparoscopic Hernia Repair
Lead sponsor: Swissmed Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective laparoscopic-endoscopic inguinal hernia repair using the Swing-Mesh™ implant. The study population includes adult patients of both sexes who meet the inclusion criteria and do not have any of the specified exclusion criteria. Participants will be recruited from surgical centers in Poland.

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 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.

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 rates compared to open surgery.

To address the limitations of flat meshes in minimally invasive procedures, three-dimensional implants have been developed. These are better suited to the anatomical structure of the myopectineal orifice (MPO), reducing the risk of mesh migration without the need for fixation.

Swing-Mesh™ is a new lightweight, macroporous 3D implant introduced to the Polish market in 2025. Its structure is based on thermally modified polypropylene fibers, eliminating the need for rigid stabilizing rings. The implant is suitable for both right- and left-sided hernias.

The aim of this study is to assess the safety and clinical performance of Swing-Mesh™ in real-world settings. The primary endpoint is the hernia recurrence rate within 6 months. Secondary outcomes include postoperative pain, early and late complications, and patient-reported groin discomfort.

This is a prospective, multicenter, observational cohort study. Consecutive patients undergoing elective laparoscopic inguinal hernia repair will be enrolled after providing informed consent. The Swing-Mesh™ (15×11 cm or 16×12 cm) will be implanted without fixation. Selected surgical steps will be documented (photo/video), anonymized, and stored on a secure research platform.

Follow-up will be conducted at 7-10 days, 30 days, 3 months, and 6 months postoperatively. Data will be collected via structured telephone interviews or in-person visits, as needed.

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 \<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

Primary outcomes:
measure: Hernia recurrence rate within 6 months
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Postoperative pain intensity (Visual Analog Scale 0-10)
timeFrame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
measure: Early and late postoperative complications
timeFrame: Up to 6 months post-surgery
measure: Groin discomfort and foreign body sensation
timeFrame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Swissmed Hospital
city: Gdańsk
country: Poland
facility: Swissmed Hospital
Study officials:
affiliation: Swissmed Hospital
name: Mateusz Zamkowski, MD, PhD
role: STUDY_CHAIR
affiliation: Swissmed Hospital
name: Maciej Śmietański, prof.
role: STUDY_DIRECTOR
References:
citation: Bittner R, Montgomery MA, Arregui E, Bansal V, Bingener J, Bisgaard T, Buhck H, Dudai M, Ferzli GS, Fitzgibbons RJ, Fortelny RH, Grimes KL, Klinge U, Kockerling F, Kumar S, Kukleta J, Lomanto D, Misra MC, Morales-Conde S, Reinpold W, Rosenberg J, Singh K, Timoney M, Weyhe D, Chowbey P; International Endohernia Society. Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society). Surg Endosc. 2015 Feb;29(2):289-321. doi: 10.1007/s00464-014-3917-8. Epub 2014 Nov 15. No abstract available.
citation: Zamkowski M, S Mietanski M, Franczak P, Gorski D, Grabias J, Janik M, Krol A, Mitura K, Medras O, Nawacki L, Romanczuk M, Rymkiewicz P, Saluk S, Sroczynski P, Sulkowski L, Wieczorek D, Wlodarczyk M. MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial. Ann Surg. 2025 Jun 1;281(6):921-927. doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.
citation: Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.
citation: Stabilini C, van Veenendaal N, Aasvang E, Agresta F, Aufenacker T, Berrevoet F, Burgmans I, Chen D, de Beaux A, East B, Garcia-Alamino J, Henriksen N, Kockerling F, Kukleta J, Loos M, Lopez-Cano M, Lorenz R, Miserez M, Montgomery A, Morales-Conde S, Oppong C, Pawlak M, Podda M, Reinpold W, Sanders D, Sartori A, Tran HM, Verdaguer M, Wiessner R, Yeboah M, Zwaans W, Simons M. Update of the international HerniaSurge guidelines for groin hernia management. BJS Open. 2023 Sep 5;7(5):zrad080. doi: 10.1093/bjsopen/zrad080.
citation: HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.