About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 3DMax MID Anatomical Mesh