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Clinical Studies

LiVac successfully completed its first clinical trial in December 2013.

news-2The trial was conducted across two hospitals and involved ten patients undergoing laparoscopic reduced port (3 port) cholecystectomy, gastric fundoplication and gastric banding, as well as single port cholecystectomy.

The liver was successfully retracted using the LiVac Retractor in all operations, which were video-recorded and independently monitored. Each patient had normal liver ultrasound the day after surgery, with no clinically significant liver function test derangements and no device-related adverse events.

European Association for Endoscopic Surgery

In July 2016, Dr. Philip Gan attended EAES in Amsterdam and upon review of the program was pleasantly surprised to find another video session that focused on independent surgeon experience with the LiVac retractor in Germany and Austria.

The study describes the application of the LiVac retractor in over 20 cases, in which the LiVac was used as the sole device for liver retraction across a range of surgical procedures. In all cases the LiVac Retractor System was “easy to apply and provided good exposure of the operative field”.

Independent Publications

Obesity Surgery, July 2016

Intraabdominal Trocar-Free Vacuum Liver Retractor for Laparoscopic Sleeve Gastrectomy (Video)

Benzing, C., Krenzien, F., Junghans, T. et al. OBES SURG (2016) 26: 1654. doi:10.1007/s11695-016-2245-6

Abstract

PURPOSE:
Retraction of the liver is essential in laparoscopic sleeve gastrectomy. Recently, a new internal liver retractor, the LiVac® device, has been introduced. The current video report (run-time 7:26 min) seeks to demonstrate the efficacy and safety of the LiVac® trocar-free liver retractor in laparoscopic sleeve gastrectomy.

MATERIALS AND METHODS:
The LiVac® retractor is inserted besides an abdominal trocar and uses the vacuum system of the operating room without the need for specific devices. The liver is retracted without the need of an assistant or extra trocars.

RESULTS:
The present case is a laparoscopic sleeve gastrectomy in a 30-year-old woman with morbid obesity (BMI 45.3 kg/m(2)). The LiVac® retractor provided an excellent view of the operative field. No problems or device-related complications occured during the procedure.

CONCLUSIONS:
The LiVac liver retractor was easy to applicate in the presented case and provided a good exposure of the operative field.

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Obesity Surgery, October 2016

One-Anastomosis Jejunal Interposition with Gastric Remnant Resection (Branco-Zorron Switch) for Severe Recurrent Hyperinsulinemic Hypoglycemia after Gastric Bypass for Morbid Obesity

Zorron, R., Branco, A., Sampaio, J. et al. OBES SURG (2016). doi:10.1007/s11695-016-2410-y

Abstract

BACKGROUND:
The anatomical and physiological changes after Roux-en-Y gastric bypass for morbid obesity can lead to severe hyperinsulinemic hypoglycemia with neuroglycopenia in a small percentage of patients. The exact physiologic mechanism is not completely understood. Surgical reversal to the original anatomy and distal or total pancreatectomy are current therapeutic options to reverse the hypoglycemic effect, with substantial associated morbidity. Our group reports a pilot clinical series of a novel surgical technique using one-anastomosis jejunal interposition with gastric remnant resection (Branco-Zorron Switch).

METHODS:
Patients with severe symptomatic hyperinsulinemic hypoglycemia refractory to conservative therapy were treated using the technique. The procedure started with resection of the remnant stomach close to pylorus. The alimentary limb was sectioned at 20 cm from the gastrojejunal anastomosis, and the rest of the alimentary limb was resected until the Y-Roux anastomosis. A hand-sutured anastomosis was then performed with the proximal alimentary limb and the remnant antrum.

RESULTS:
Four patients were successfully submitted to the procedure with reversal of the symptomatology and normalization of insulin levels, postprandial glucose levels, and oral glucose tolerance test, with a mean follow-up of 24.3 months. Mean operative time was 188 min, and patients recovered without postoperative complications.

CONCLUSION:
Patients suffering from severe hyperinsulinemic hypoglycemia after gastric bypass may be efficiently treated by this innovative procedure, avoiding extreme surgical therapy such as pancreatectomy or restoring the gastric anatomy, while still maintaining sustained weight loss. Studies with larger series and longer follow-up are still needed to define the role of this therapy in managing this entity.

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Surgical Innovation, February 2017

Intra-abdominal Trocar-Free Vacuum Liver Retractor for Upper-Gastrointestinal Surgery

Benzing, C., Weiss, H., Krenzien, F., Biebl, M., Pratschke, J., Zorron, R. SURG INNOV (2017)

Abstract

BACKGROUND:
In laparoscopic upper-gastrointestinal (GI) surgery, an adequate retraction of the liver is crucial. Especially in single-port surgery and obese patients, problems may occur during liver retraction. The current study seeks to evaluate the efficacy and safety of the LiVac trocar-free liver retractor in laparoscopic upper-GI surgery.

METHODS:
The present study is a nonrandomized dual-center clinical series describing our preliminary results using the LiVac system for liver retraction. The primary end points of the present study included the effectiveness and safety of the LiVac device as well as complications and documentation of problems with the device during surgery.

RESULTS:
The device was used in 11 patients for simple and complex laparoscopic procedures. The mean age of the study population was 59.6 years (SD = 20.6; range = 30-84). There were 6 female and 5 male patients with a mean body mass index (BMI) of 31.9 kg/m2 (SD = 8.1; range = 26.0-45.3). The efficacy of the device was excellent in all cases, reducing the number of trocars needed. There were no device-related complications.

CONCLUSION:
The LiVac liver retractor is easy to use and provides a good exposure of the operative field in upper-GI laparoscopic surgery, even in obese patients with a high BMI.

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