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.

inclusion criteria
among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
Gallbladder with surrounding organs due to gallbladder inflammation
Patients over 19 years of age
First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used as before and during surgery.

among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
Gallbladder with surrounding organs due to gallbladder inflammation
Patients over 19 years of age
Sencond-generation cephalosporin (Shincef inj., 750mg, Cefuroxime sodium, Shin-poong pharm.co.) was used as before and during surgery.

Cholecystitis, Acute

Method of operation
Surgery was started under general anesthesia
A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.
Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
The trocar was removed and the skin was sutured
On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)

Laparoscopic cholecystectomy

Department of HBP Surgery, Seoul St. Mary's hospital

Empirical Antibiotics in Acute Inflammatory Gallbladder Disease

Results of Surgical Management According to the Type of Empirical Antibiotics in Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial

Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and the second-generation cephalosporin.

The duration between the operation day and the day of discharge

pneumoperitoneum/phosphatase

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

Empirical Antibiotics in Acute Inflammatory Gallbladder Disease

Kidney Function After Pneumoperitoneum and Analgesia

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