An observational study in Hernia, Inguinal, sponsored by Swissmed Hospital. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Swissmed Hospital · Observational
This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.
The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.
All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.
Laparoendoscopic techniques such as transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair are widely used for the treatment of inguinal hernia and are associated with faster recovery and lower rates of chronic pain compared with open repair in appropriately selected patients. Mesh reinforcement is a key component of these procedures. Three-dimensional, anatomically contoured meshes have been developed to improve conformability to the myopectineal orifice and to provide stable coverage of the inguinal region, potentially reducing the need for additional fixation and lowering the risk of chronic postoperative pain.
The 3DMax MID Anatomical Mesh (BD, USA) is a medium-weight, macroporous, pre-shaped polypropylene mesh designed specifically for inguinal hernia repair. Its three-dimensional configuration and recoil properties are intended to facilitate correct positioning and stable coverage of the inguinal anatomy during laparoendoscopic procedures.
This multicenter, prospective, observational cohort study will include consecutive adult patients undergoing elective TAPP or TEP inguinal hernia repair in participating centers, in whom the operating surgeon has decided to use the 3DMax MID Anatomical Mesh as part of routine practice. No randomization or control group is planned, and no interventions outside standard care will be performed.
Data will be collected from medical records and structured follow-up contacts (early postoperative check, approximately 30 days, 3 months and 12 months after surgery). The primary endpoint is hernia recurrence within 12 months. Secondary endpoints include postoperative pain, groin discomfort, foreign body sensation and early or late postoperative complications. Study data will be recorded in a standardized database and analyzed descriptively to characterize the safety profile and clinical performance of the 3DMax MID Anatomical Mesh in real-world practice.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's planned enrollment of 300 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.
Adult patients with primary unilateral or bilateral inguinal hernia undergoing elective laparoendoscopic (TAPP or TEP) repair with implantation of the 3DMax MID Anatomical Mesh in participating centers.
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.
Adult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique.
Device: 3DMax MID Anatomical Mesh
Implantation of a pre-shaped, medium-weight, macroporous polypropylene anatomical mesh (3DMax MID Anatomical Mesh, BD, USA) during elective laparoendoscopic inguinal hernia repair (TAPP or TEP) as part of routine clinical practice. No additional experimental procedures beyond standard surgical care are planned.
Also known as: 3DMax MID
Inguinal hernia recurrence rate at 12 months
Proportion of patients with clinically and/or imaging-confirmed inguinal hernia recurrence within 12 months after the index laparoendoscopic repair with 3DMax MID Anatomical Mesh.
Time frame: 12 months after index surgery
Postoperative pain intensity (VAS 0-10)
Postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS) during early and late follow-up. Chronic pain will be defined as VAS ≥4 persisting beyond 3 months after surgery.
Time frame: 7-10 days, 30 days, 3 months and 12 months after surgery
Early postoperative complications (≤30 days)
Incidence of early postoperative complications within 30 days after surgery, including wound infection, hematoma, seroma, urinary retention, bleeding, and other mesh- or procedure-related adverse events.
Time frame: Up to 30 days after surgery
Late postoperative complications (>30 days to 12 months)
Incidence of late postoperative complications occurring between 30 days and 6 months after surgery, including chronic groin pain, mesh-related complications, and reoperations in the operated groin.
Time frame: From >30 days to 12 months after surgery
Groin discomfort and foreign body sensation
Patient-reported groin discomfort, stiffness and foreign body sensation in the operated region, assessed using standardized questions or Likert-type scales (0-10) during follow-up contacts.
Time frame: 7-10 days, 30 days, 3 months and 12 months after surgery
Plan to share: Undecided
Ran from Feb 2026 to primary completion in Apr 2026, 2 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 2 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 active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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