Sikkerhet og effekt av Swing-Mesh ™ -implantatet (THT Bioscience ™, B. Braun ™, Frankrike) i laparoskopisk-endoskopisk inguinal brokkreparasjon-et multisenter, kohort, prospektiv observasjonsstudie. (SMS)
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Gdansk, Polen, 80-280
- Swissmed Hospital
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Gdańsk
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Gdansk, Gdańsk, Polen, 80-215
- Swissmed Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Swing-Mesh™ Cohort
Patients undergoing elective laparoscopic-endoscopic inguinal hernia repair (TAPP or TEP) using the Swing-Mesh™ implant without fixation. Follow-up is conducted at 7-10 days, 30 days, 3 months, and 6 months to assess recurrence, pain, complications, and groin discomfort. |
A lightweight, macroporous, three-dimensional polypropylene mesh implant developed by THT BioScience™ and distributed by B. Braun™, used in laparoscopic-endoscopic inguinal hernia repair without fixation. The mesh is designed to conform to the anatomical shape of the myopectineal orifice and is available in two sizes (15×11 cm or 16×12 cm).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Hernia recurrence rate within 6 months
Tidsramme: 6 months post-surgery
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Incidence of clinically or radiologically confirmed inguinal hernia recurrence during a 6-month follow-up period. Expected recurrence rate: 2-4%. |
6 months post-surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative pain intensity (Visual Analog Scale 0-10)
Tidsramme: 7-10 days, 30 days, 3 months, and 6 months post-surgery
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Evaluation of postoperative pain using the Visual Analog Scale (VAS) at specified time points. Chronic pain defined as pain ≥4/10 persisting beyond 3 months. |
7-10 days, 30 days, 3 months, and 6 months post-surgery
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Early and late postoperative complications
Tidsramme: Up to 6 months post-surgery
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Assessment of complications such as wound infection, hematoma, and seroma within 30 days (early) and up to 6 months (late). |
Up to 6 months post-surgery
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Groin discomfort and foreign body sensation
Tidsramme: 7-10 days, 30 days, 3 months, and 6 months post-surgery
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Patient-reported outcomes regarding groin discomfort and sensation of a foreign body during scheduled follow-up interviews. |
7-10 days, 30 days, 3 months, and 6 months post-surgery
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Mateusz Zamkowski, MD, PhD, Swissmed Hospital
- Studieleder: Maciej Śmietański, prof., Swissmed Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SMS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data (e.g., recurrence outcomes, VAS scores) may be shared upon reasonable request, after publication of the study results.
IPD-delingstidsramme
After completion of the study and publication of results
Tilgangskriterier for IPD-deling
Requests must be made by qualified researchers with a methodologically sound proposal, subject to approval by the study investigators.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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