Port-site closure hernias are underdiagnosed and overly prevalent, reports neoSurgical Inc. The company has announced the start of a Postmarket Surveillance Study of its FDA-cleared device, neoClose®, comparing it against standard closure technique.
Laparoscopic abdominal surgery requires the creation of port sites in the abdomen, which are closed at the end of the procedure. Subsequent “trocar site hernia”, (TSH), 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 Lap surgery port sites closed each year. But recent studies have proposed a TSH rate of 26%, supporting the proposition that they have been hitherto underdiagnosed. Indeed another study, this time looking into TSH following laparoscopic or robotic Roux-en-Y gastric bypass, reported a 39.3% TSH rate at three years.
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.
The newly reported randomized study, based out of University of Texas Health Sciences Center at Houston, 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: Erik B. Wilson, MD, Professor of Surgery; Peter A. Walker, MD, Assistant Professor of Surgery; and, Shinil K. Shah, DO, Assistant Professor of Surgery.
“Surgeons in hospitals across the United States are rapidly adopting our neoClose® device. 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,” said Barry Russell, CEO of neoSurgical.
Source: neosurgical Ltd.