Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

Overview

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.