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.
Age 18 years or older
Primary unilateral or bilateral inguinal hernia
Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)
Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon
Age below 18 years
Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)
Contaminated or potentially contaminated surgical field
Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)
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.
Cohort
Prospective
3DMax MID Anatomical Mesh
DeviceImplantation 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.
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.
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.
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.
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.
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 during follow-up contacts.
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