Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Inguinal Hernia Recurrence Within 12 Months — From surgery through 12 months after surgery.
  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.

Trial sites (1)

More Swissmed Hospital trials in Poland