Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair - Multicenter, Prospective Observational Study

N/ANot Yet RecruitingNCT07289802

Swissmed Hospital300 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * 3DMax MID Anatomical Mesh planned for use as part of routine clinical care * Ability and willingness to provide written informed consent Exclusion Criteria: * 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) * Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required * Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 during follow-up contacts.