An observational study in Inguinal Hernia, sponsored by Swissmed Hospital. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Swissmed Hospital · Observational
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.
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.
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.
Exclusion Criteria:
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
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.
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.
Time frame: From surgery through 12 months after surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7-10 days, 30 days, 6 months, and 12 months after surgery.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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