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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSwissmed Hospital

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

Treatment groups

300 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators