Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department.
The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura Approximation device and fixation of mesh with tacks over the closed defect.
Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months.

Primary Umbilical Hernia

Umbilical Hernia

the use of the study device during a laparoscopic surgery

Su2ura Approximation Device

repairing primary umbilical hernia in a laparoscopic procedure using the study device.

Laparoscopic hernia repair surgery

Ziv Medical Center

Barzilai Medical Center

Splošna bolnišnica Izola (General Hospital Izola)

Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device

AEs and SADEs will be documented and reviewed to assess the safety of the device

During follow-up period patients with reaccuring hernia will be documented and reviewed to assess the efficacy of this device

During follow-up period patients satisfaction will be followed and documented and reviewed to assess the efficacy of this device

During follow-up period patients with tissue bulging will be documented and reviewed to assess the efficacy of this device

During follow-up period patients with seroma will be documented and reviewed to assess the efficacy of this device

Anchora Medical

All recruited patients will undergo a laparoscopic hernia repair procedure using the Su2ura Approximation Device.

pneumoperitoneum/triglyceride

Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device

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