Inguinal HerniaOPTIMUSNCT07836179
Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Swissmed Hospital at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Optomesh 3D
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2026to 1 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
LUX MED Szpital Gdańsk
Gdansk, 80-215
Mateusz Zamkowski, MD, PhD, +48504236036
About this study
Official title: Safety and Efficacy of the Optomesh® 3D Implant (TZMO S.A., Poland) in Laparoscopic-Endoscopic Inguinal Hernia Repair - A Multicenter, Prospective Observational Study (OPTIMUS Study)
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.
Read the detailed description
OPTIMUS is a prospective, multicenter, observational cohort study evaluating the safety and clinical performance of the Optomesh® 3D implant (TZMO S.A., Poland) in elective laparoendoscopic inguinal hernia repair. The study focuses on outcomes after transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair with mesh placement without additional fixation. Each participant will be followed for 12 months after surgery.
Optomesh® 3D is an anatomically shaped, non-absorbable polypropylene mesh intended for inguinal hernia repair. It is manufactured from transparent and blue monofilament polypropylene yarn and includes an orientation marker. Right-sided and left-sided variants are available in S/M and L sizes. The implant variant and size are selected according to the patient's anatomy.
Consecutive patients of both sexes undergoing elective repair with this implant will be considered for enrollment at participating surgical centers. Participation requires written informed consent and fulfillment of the study eligibility criteria. Collected data will include patient characteristics, body mass index, comorbidities, surgical approach, operative time, and implant size. Operative documentation will include video recordings or photographs of surgical steps. These materials will be coded and made available to investigators through a restricted-access platform. Study data will be stored in a secured database.
Follow-up assessments will take place at 7-10 days, 30 days, 3 months and 12 months after surgery. Telephone questionnaires will collect information on recurrence, pain, complications, groin discomfort, and foreign body sensation. Pain intensity will be assessed using a 0-10 visual analog scale. Chronic pain will be evaluated as pain persisting beyond 3 months, interfering with daily activities, and exceeding 4/10 on the pain scale. Early complications will be assessed within 30 days, with further complication assessment throughout the 12-month follow-up.
The primary outcome is inguinal hernia recurrence within 12 months after surgery. The primary analysis will estimate the 12-month recurrence rate, together with a 95% confidence interval. Outcomes will be interpreted in relation to historical benchmarks specified in the study protocol and statistical analysis plan. Additional analyses will describe changes in pain and other patient-reported symptoms over time and explore associations between outcomes and patient characteristics, surgical approach, and implant size.
- Conditions
- Inguinal Hernia
- Being tested
- Optomesh 3D
- 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
- Medical subject headings
- Hernia, Inguinal, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optomesh 3DDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optomesh 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery through 12 months after surgery.
Secondary outcomes (5)
Postoperative Groin Pain Intensity
Mean postoperative groin pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity. Results will be reported separately for each assessment time point.
Measured: 7-10 days, 30 days, 3 months and 12 months after surgery.
Chronic Postoperative Inguinal Pain
Percentage of participants with pain in the operated groin persisting for more than 3 months, interfering with daily activities, and exceeding 4 on the 0-10 Visual Analog Scale (VAS). A score of 0 represents no pain and 10 represents the worst imaginable pain. Results will be reported separately at each assessment.
Measured: 3 months and 12 months after surgery.
Early Postoperative Complications
Percentage of participants experiencing at least one early postoperative complication, including wound infection, hematoma, or seroma, within 30 days after surgery. The frequency of each complication type will also be reported separately.
Measured: From surgery through postoperative day 30.
Late Postoperative Complications
Percentage of participants with at least one late postoperative complication, including fistula or persistent or newly diagnosed seroma, occurring or persisting beyond postoperative day 30. The frequency of each complication type will also be reported separately.
Measured: Postoperative day 31 through 12 months after surgery.
Groin Discomfort
Percentage of participants reporting discomfort in the operated groin during follow-up telephone interviews. The presence or absence of discomfort will be recorded, and results will be reported separately for each assessment time point.
Measured: 7-10 days, 30 days, 6 months, and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Zamkowski, Swissmed Hospital
- Investigators
- Mateusz Zamkowski, MD, PhD, Study chair, LUX MED Hospital in Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836179
- Sponsor's protocol ID
- OPTIMUS
- Acronym
- OPTIMUS
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published OPTIMUS study results will be made available upon reasonable request. Shared data will include relevant demographic and operative characteristics, hernia recurrence within 12 months, postoperative pain, complications, groin discomfort, and foreign body sensation. A data dictionary will accompany the dataset. Data sharing will be consistent with participant consent and applicable data protection requirements.
Publications
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.
PubMed 41757330Zamkowski 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.
PubMed 42057962Zamkowski 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.
PubMed 36229552Zamkowski 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.
PubMed 39945075HerniaSurge 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.
PubMed 29330835Stabilini 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.
PubMed 37862616