Health TrialsbyHealthPanel

Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

ConditionInguinal Hernia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSwissmed Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age below 18 years.

Emergency surgery, including emergency repair of an incarcerated inguinal hernia.

Contaminated surgical field.

Recurrent inguinal hernia.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Optomesh 3D

    Device

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Optomesh 3D Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swissmed Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: