An observational study in Inguinal Hernia, sponsored by Swissmed Hospital. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Swissmed Hospital · Observational
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.
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.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 323 is above the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Swissmed Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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™
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
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%.
Time frame: 6 months post-surgery
Postoperative pain intensity (Visual Analog Scale 0-10)
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.
Time frame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
Early and late postoperative complications
Assessment of complications such as wound infection, hematoma, and seroma within 30 days (early) and up to 6 months (late).
Time frame: Up to 6 months post-surgery
Groin discomfort and foreign body sensation
Patient-reported outcomes regarding groin discomfort and sensation of a foreign body during scheduled follow-up interviews.
Time frame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
Plan to share: Yes — De-identified individual participant data (e.g., recurrence outcomes, VAS scores) may be shared upon reasonable request, after publication of the study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Ran from Apr 2025 to primary completion in Aug 2025, 4 months.
Of 51 non-industry observational studies under Hernia, Inguinal, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 68. This study's 4 months is below that.
Counting every sponsor, half of 57 studies reached it within 18 months; a quarter within 9 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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