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Clinical Trials in Poland / NCT07289802
Active, not recruiting Observational

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

NCT07289802 · tracked via the Priya Life Science Poland tracker
Sponsor
Swissmed Hospital
Phase
Observational
Started
2026-02-01
Last updated
2026-09-18

Condition(s) studied

Hernia, Inguinal

Investigational drug(s) / intervention(s)

3DMax MID Anatomical Mesh

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Inguinal hernia recurrence rate at 12 months — 12 months after index surgery
    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.

Trial sites (1)

FacilityCityRegionStatus
Swissmed Hospital Gdansk Poland

More Swissmed Hospital trials in Poland

Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair Recruiting
Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07289802 on ClinicalTrials.gov ↗ ← All trials in Poland