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

Taeho Hong

Professor

Seoul St. Mary's Hospital

laparotomy intervention with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall.
V-Loc 180 (ref VLOCL0024, lot. A1D0899)

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PP mesh was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia.
Other names: V-Loc 180 (ref VLOCL0024, lot. A1D0899) PR Parietene mesh Tyco (ref. PP3030, lot. SIK00587)

A surgical scar was performed on the abdominal linea alba and carried out deeply for entering into the abdominal cavity. In five rabbits (BPR21-BPR25). A 2x2cm2 BP intraperitoneal mesh was then be inserted with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut.

Five rabbits (R26-R30) will be used as control group.

Hernia of Abdominal Wall

Incisional Hernia

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall.

BP selfstanding felt

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PR (polypropylene) prosthesis was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia

PP mesh

Laparotomy on the linea alba carried out deeply for entering into the abdominal cavity, a 2x2cm2 BP sample implantation with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut

BP intraperitoneal mesh

observational intervention in 5 rabbits with the same body weight and the same age will be observed and will be feeded in the same way of the BP device intraperitoneal implanted group

control group

Carbon nanotubes toxicology and effects on metabolism and immunological modification in vitro and in vivo

prot. C26A10HCNR, founding of 35000€ Prof Lucio D'Ilario, Prof. Andrea Martinelli, Dott. Massimo Chiaretti , prot letter 0003306 project n° 304P25, interfaculty Chemistry Dep, General Surgery Paride Stefanini Dep.

National Health Institute (ISS Istituto Superiore di Sanità), Viale Regina Elena 299

"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"

The Buckypaper as a New Device in the Treatment of Some Solid Cancer and Hematopoietic System Tumors and as a New Fixing Device for Prosthetic Surgery. In Vivo Study on Effects of BP Implantation, Preliminary to Human Surgical Applications

Durability (in months) without recurrence of hernia and incisional hernia of surgical device.

Ability (number of mm displacement from the point of implantation at 12 weeks after BP implantation) of the BP as bio-adhesive tape for prosthetic materials to avoid displacement of implanted prosthesis.

toxicology of BP measured as number of BP fragments in bioptic samples of Bowman capsule of the nephron at 12 weeks

antineoplastic activity of BP device in the treatment of some solid cancer and hematopoietic system tumors: this item is measured ex vivo as the ability of BP to inhibit tumor cell replication (number of viable tumor cells in cultures after 48 hours of exposition to BP)

toxicology of BP measured as modifications of values (delta) of creatinine, transaminasis and PT, PTT, fibinogen in blood samples from the T0 to 12 weeks.

seroma/potassium

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

Empirical Antibiotics in Acute Inflammatory Gallbladder Disease

"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"

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