Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair
Not yet recruitingNCT07836179
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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)
- Conditions
- Interventions
- Device: Optomesh 3D
- Sponsor
- Swissmed Hospital
- Start date
- 2026-11-01
- Primary completion
- 2027-02-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07836179