Swing-Mesh™ Study (SMS).

NCT06915155 | Active Not Recruiting

• 1 other identifier: SMS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

Mesh; Groin Hernia; Hernia; TAPP; TEP; Inguinal Hernia; Minimally Invasive Surgery; Laparoscopic Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Hernia recurrence rate within 6 months

  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

Secondary Outcomes (3)

• Postoperative pain intensity (Visual Analog Scale 0-10)

  7-10 days, 30 days, 3 months, and 6 months post-surgery

• Early and late postoperative complications

  Up to 6 months post-surgery

• Groin discomfort and foreign body sensation

  7-10 days, 30 days, 3 months, and 6 months post-surgery

Study Arms (1)

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.

Device: Swing-Mesh™

Interventions

Swing-Mesh™ DEVICE

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).

Also known as: THT BioScience mesh, 3D hernia mesh, SwingMesh, B. Braun mesh

Swing-Mesh™ Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• elective groin hernia repair
• age \> 18 years
• male and female patients can participate
• eligibility for laparoendoscopic repair
• signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Swissmed Hospital: lead

Study Sites (2)

Swissmed Hospital

Gdansk, Gdańsk, 80-215, Poland

Location

Swissmed Hospital

Gdansk, 80-280, Poland

Location

Related Publications (5)

• 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.

  PMID: 25398194 RESULT

• 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.

  PMID: 39945075 RESULT

• 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.

  PMID: 36229552 RESULT

• 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.

  PMID: 37862616 RESULT

• 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.

  PMID: 29330835 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mateusz Zamkowski, MD, PhD

  Swissmed Hospital

  STUDY CHAIR

• Maciej Śmietański, prof.

  Swissmed Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 7, 2025
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the study and publication of results
• Access Criteria: Requests must be made by qualified researchers with a methodologically sound proposal, subject to approval by the study investigators.

Locations

PL (2)