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Active Not Recruiting
NCT07289802
Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair
Conditions: Hernia, Inguinal
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Swissmed Hospital
Location: Swissmed Hospital Gdansk
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 Criteria
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)
Source: ClinicalTrials.gov (NCT07289802). StuddyBuddy aggregates publicly available trial information.