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Gastric bypass neoclose study

neoSurgical begins gastric bypass neoclose study

neoClose (Credit: neoSurgical)
neoSurgical begins postmarket surveillance study of neoClose vs. standard of care for closing port site incisions in laparoscopic and robotic surgeries

neoSurgical has that it has begun a Postmarket Surveillance Study of its FDA-cleared device, neoClose, at University of Texas Health Sciences Center at Houston, TX. The randomised study will compare neoClose against the standard of care for closure in a bariatric surgery gastric bypass population of 70 adults aged 18-70 years with BMI>35. Principal investigators include: Drs Erik B Wilson, Professor of Surgery; Peter A Walker, Assistant Professor of Surgery and Shinil K Shah, Assistant Professor of Surgery.

Laparoscopic abdominal surgery requires small incisions or ‘port sites’ in the abdomen. The port site must be closed after laparoscopic surgery and although laparoscopic surgery itself is minimally invasive, ‘herniation’ (the protrusion of abdominal tissue through the port site after closure (commonly referred to as “trocar site hernia (TSH), among doctors), can lead to morbidity due to small bowel strangulation, for example, or nerve and vessel entrapment, resulting in infection, bleeding and pain.

Until 2014, TSH complications were thought to occur at a reported rate of about 1-6% among the six million laparoscopic surgery port sites closed each year. However, in a clinical study (Comajuncosas, J, et al. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg. 2014 Jan; 207(1):-6), nearly 26% of patients were diagnosed with TSHs. Thus, TSHs have been grossly under-diagnosed.

Following the Comajuncosas study, a second published study (Scozzari et al. High incidence of trocar site hernia after laparoscopic or robotic Roux-en-Y gastric bypass. SurgEndosc. 2014 Oct; 28(10):2890-8), the total trocar site hernia rate was 39.3% at three years.

Most recently a third, multi-institutional study (Holihan JL et al. Adverse events after Ventral Hernia repair: The vicious Cycle of complications, JACS 2015) revealed that hernia occurrence can lead to a repetitive cycle of repeat procedures and complications.

The standard for port site closure has been closed loop suture. Now, there’s neoClose, which works by the use of a Vector X closure, approximating the tissue together and tying into place for a secure closure with up to 75% less tension compared to standard closed loop suture.

neoClose is approved for sale in the US and Europe and designed to be the new standard for Lap surgery port site closure, a potential US$300 million opportunity. The company’s neoClose system for port site closure has now been used more than 7,000 times in hospitals across the US.

neoClose delivers two absorbable AutoAnchor into the abdominal wall, both consisting of a suture and an anchor. The sutures are knotted at the end of a procedure, facilitating approximation of the incision (Figure 1).

Figure 1: neoClose Overview (Credit: neoSurgical)

neoClose’ method of approximation (Vector X) is associated with reduced tension at wound sites compared to more traditional methods of closed loop approximation (Figure 2). According to the company, closed loop approximation in the lower abdomen is associated with a 5% risk of clinically significant pain due to nerve injury. neoClose has the potential to lower this risk, due to reduced tension.

Figure 2: Less Stress with neoClose means potential to reduce complications from port site closure following lap surgery. Sources - 1. Shin JH, Howard FM. Abdominal wall nerve injury during laparoscopic gynecologic surgery: incidence, risk factors, and treatment outcomes. J Minim Invasive Gynecol. 2012 Aug;19(4):448–53. 2. Nawaz Z, Bentley G. Surgical incisions and principles of wound healing. Basic Ski. 2011 Feb;29(2):59–62. 3. Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009;2(3):146–58. 4. Independent Study completed by the National University of Ireland, Galway. Data on file at neoSurgical. (Credit: neoSurgical)

The company believes that minimising wound tension contributes to a suitable environment for optimal wound healing, as over-tightened sutures can lead to tissue necrosis and excessive tissue overlap, which results in reduced tensile strength in the healed tissue.

“Surgeons in hospitals across the US are rapidly adopting our neoClose device,” said Barry Russell, CEO of neoSurgical. “This Postmarket Surveillance Study is intended to build our clinical evidence behind neoClose and to begin to establish the superiority of neoClose versus the standard of care for closing port sites — a standard that absolutely must be improved to enhance patient outcomes and safety.”

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