Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

NCT07836179 | Not Yet Recruiting

• 1 other identifier: OPTIMUS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

OPTIMUS is an observational study assessing the safety and effectiveness of Optomesh 3D, a shaped surgical mesh used in planned keyhole surgery for a groin (inguinal) hernia. The mesh is placed without additional stitches, tacks, or glue to hold it in position. The study aims to include at least 300 patients from several hospitals. The main question is how often a hernia returns within 12 months after surgery. Researchers will also assess pain, postoperative complications, discomfort in the groin, and the feeling of having a foreign material in the operated area. Participants will provide written consent for the study. Information about their health and operation will be recorded. Follow-up information will be collected through telephone interviews at 7-10 days, 30 days, 3 months, and 12 months after surgery. The results will be assessed in relation to previously published findings on hernia repair.

Conditions

Inguinal Hernia

Keywords

optomesh 3d; OPTIMUS; Inguinal Hernia Repair; Polypropylene Mesh; Anatomically Shaped Mesh; Mesh Non-Fixation; Transabdominal Preperitoneal Repair (TAPP); Totally Extraperitoneal Repair (TEP); Hernia Recurrence; Chronic Postoperative Inguinal Pain; Postoperative Complications; Foreign Body Sensation

Outcome Measures

Primary Outcomes (1)

• Inguinal Hernia Recurrence Within 12 Months

  Percentage of participants reporting recurrence of an inguinal hernia at the operated site within 12 months after the index operation. Information on recurrence is collected through scheduled follow-up telephone interviews.

  From surgery through 12 months after surgery.

Secondary Outcomes (5)

• Postoperative Groin Pain Intensity

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

• Chronic Postoperative Inguinal Pain

  3 months and 12 months after surgery.

• Early Postoperative Complications

  From surgery through postoperative day 30.

• Late Postoperative Complications

  Postoperative day 31 through 12 months after surgery.

• Groin Discomfort

  7-10 days, 30 days, 6 months, and 12 months after surgery.

Study Arms (1)

Optomesh 3D Cohort

Consecutive patients undergoing elective laparoendoscopic inguinal hernia repair using Optomesh 3D without additional mesh fixation at participating centers. Surgery is performed using either the transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) approach as part of routine clinical care. Participants are followed prospectively for 12 months after surgery to assess hernia recurrence, postoperative pain, complications, groin discomfort, and foreign body sensation.

Device: Optomesh 3D

Interventions

Optomesh 3D DEVICE

Optomesh 3D (TZMO S.A., Poland) is an anatomically shaped, non-absorbable polypropylene mesh used for inguinal hernia repair. The implant is available in right-sided and left-sided variants and in S/M and L sizes. The mesh is placed in the preperitoneal space during TAPP or TEP repair without additional fixation using sutures, tacks, or glue. The implant variant and size are selected according to the patient's anatomy. Outcomes following mesh implantation are recorded prospectively in this observational study.

Optomesh 3D Cohort

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

Consecutive patients aged 18 years or older, of either sex, presenting to participating surgical centers for elective repair of a primary inguinal hernia. The study includes patients undergoing transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair using Optomesh 3D without additional mesh fixation as part of routine clinical care. Patients meeting the eligibility criteria and providing written informed consent will be enrolled and followed prospectively for 12 months after surgery.

You may qualify if:

• Age 18 years or older.
• Male or female patients scheduled for elective repair of a primary inguinal hernia.
• Eligibility for laparoendoscopic repair using the transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) approach.
• Planned use of Optomesh 3D without additional mesh fixation as part of routine clinical care.
• Written informed consent to participate in the study.

You may not qualify if:

• Age below 18 years.
• Emergency surgery, including emergency repair of an incarcerated inguinal hernia.
• Contaminated surgical field.
• Recurrent inguinal hernia.
• Extremely large scrotal hernias requiring additional measures to prevent abdominal compartment syndrome, such as botulinum toxin administration, progressive preoperative pneumoperitoneum, or bowel resection for volume reduction.
• M3 or combined M3+L1-L3 inguinal hernia according to the European Hernia Society (EHS) classification, confirmed intraoperatively.

Sponsors & Collaborators

• Swissmed Hospital: lead

Study Sites (1)

LUX MED Szpital Gdańsk

Gdansk, 80-215, Poland

Location

Related Publications (6)

• Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Putko M, Smietanski M. Mechanical stability of new-generation meshes for M3 inguinal hernia repair: experimental pressure chamber testing of SWING-Mesh and 3DMax MID Anatomical Mesh. Wideochir Inne Tech Maloinwazyjne. 2025 Oct 29;20(4):409-414. doi: 10.20452/wiitm.2025.17990. eCollection 2025 Dec 29.

  PMID: 41757330 BACKGROUND

• Zamkowski M, Bekarski M, Bialecki J, Chudek J, Dobkowski G, Franczak P, Grabias J, Golyski J, Kisielewski K, Kontek M, Krol A, Lavrynets V, Molasy B, Mitura K, Piatek-Czypionka D, Putko M, Ropel J, Rymkiewicz P, Saluk S, Sulkowski L, Wieczorek D, Wlodarczyk M, Wojcik M, Smietanski M. Early safety and effectiveness of new 3-dimensional lightweight SWING-Mesh in minimally-invasive inguinal hernia repair: a multicenter prospective observational study with 3-month follow-up. Wideochir Inne Tech Maloinwazyjne. 2026 Feb 3;21(1):29-36. doi: 10.20452/wiitm.2025.18012. eCollection 2026 Mar 31.

  PMID: 42057962 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, 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

• HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

  PMID: 29330835 BACKGROUND

• Stabilini C, van Veenendaal N, Aasvang E, Agresta F, Aufenacker T, Berrevoet F, Burgmans I, Chen D, de Beaux A, East B, Garcia-Alamino J, Henriksen N, Kockerling F, Kukleta J, Loos M, Lopez-Cano M, Lorenz R, Miserez M, Montgomery A, Morales-Conde S, Oppong C, Pawlak M, Podda M, Reinpold W, Sanders D, Sartori A, Tran HM, Verdaguer M, Wiessner R, Yeboah M, Zwaans W, Simons M. Update of the international HerniaSurge guidelines for groin hernia management. BJS Open. 2023 Sep 5;7(5):zrad080. doi: 10.1093/bjsopen/zrad080.

  PMID: 37862616 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Mateusz Zamkowski, MD, PhD

  LUX MED Hospital in Gdańsk

  STUDY CHAIR

Central Study Contacts

Mateusz Zamkowski, MD, PhD

CONTACT

+48 504 236 03; zamek@gumed.edu.pl

Dominika Łuczkowska

CONTACT

+48 668 720 015; d.p.luczkowska@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FEBS AWS

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data and supporting documents will be available from the date of publication of the primary study results and for 5 years following that publication.
• Access Criteria: Qualified researchers may request access by submitting a scientifically sound research proposal and analysis plan to the Sponsor-Investigator, Mateusz Zamkowski, at zamek@wp.eu. Requests will be reviewed for scientific merit, feasibility, and consistency with participant consent and data protection requirements. Following approval and agreement on the terms of use, the relevant de-identified dataset, data dictionary, and supporting documents will be provided through a secure transfer method.

Locations

PL (1)