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

NCT07289802 | Not Yet Recruiting

• 1 other identifier: 3DMID-PL
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hernia, Inguinal

Keywords

Hernia; Mesh; Inguinal Hernia; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after index surgery

Secondary Outcomes (4)

• Postoperative pain intensity (VAS 0-10)

  7-10 days, 30 days, 3 months and 12 months after surgery

• Early postoperative complications (≤30 days)

  Up to 30 days after surgery

• Late postoperative complications (>30 days to 12 months)

  From >30 days to 12 months after surgery

• Groin discomfort and foreign body sensation

  7-10 days, 30 days, 3 months and 12 months after surgery

Study Arms (1)

3DMax MID TAPP/TEP

Adult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique.

Device: 3DMax MID Anatomical Mesh

Interventions

3DMax MID Anatomical Mesh DEVICE

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.

Also known as: 3DMax MID

3DMax MID TAPP/TEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with primary unilateral or bilateral inguinal hernia undergoing elective laparoendoscopic (TAPP or TEP) repair with implantation of the 3DMax MID Anatomical Mesh in participating centers.

You may qualify if:

• 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
• DMax MID Anatomical Mesh planned for use as part of routine clinical care
• Ability and willingness to provide written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swissmed Hospital: lead

Related Publications (4)

• Zamkowski M, S Mietanski M, Franczak P, Gorski D, Grabias J, Janik M, Krol A, Mitura K, Medras O, Nawacki L, Romanczuk M, Rymkiewicz P, Saluk S, Sroczynski P, Sulkowski L, Wieczorek D, Wlodarczyk M. MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial. Ann Surg. 2025 Jun 1;281(6):921-927. doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.

  PMID: 39945075 BACKGROUND

• Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.

  PMID: 36229552 BACKGROUND

• Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.

  PMID: 37670376 BACKGROUND

• Mateusz Zamkowski, Agnieszka Tomaszewska, Izabela Lubowiecka, Krzysztof Karbowski, Michał Putko, Maciej Śmietański. Mechanical stability of new-generation meshes for M3 inguinal hernia repair: experimental pressure chamber testing of SWING-Mesh® and 3DMax™ MID Anatomical Mesh DOI: 10.20452/wiitm.2025.17990 Published online: October 29, 2025

  BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hernia; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Maciej Śmietański, Prof.

  LUX MED Hospital in Gdańsk

  STUDY CHAIR

• Mateusz Zamkowski, MD, PhD

  LUX MED Hospital in Gdańsk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Zamkowski, MD, PhD

CONTACT

22 543 33 60; zamek@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12