Abstract
Background The incidence of port site hernia (PSH) after laparoscopic surgery can reach up to 4 %. The fascial closure at the port site can be challenging in some cases.Methods A multi-center, prospective, open label study to evaluate a new integrated port closure system (Gordian TroClose™ 1200 by Gordian Surgical™), is presented.Results Fifty patients were enrolled in the study. All enrolled patients underwent laparoscopic surgery, during which at least one TroClose1200 device was used per patient. Patients were followed for two and six weeks and for one year. No port PSH related to TroClose 1200 device was diagnosed at one year of follow-up. One PSH was diagnosed at a non-TroClose1200 trocar site. The surgeons were very satisfied with the new device’s performance, with an average range of 4.8-5.0 out of 5.0 usability question being above 4.80 out of 5. No severe adverse events or device related adverse events were observed.Conclusions The TroClose 1200 is a simple, safe and friendly device that may reduce the incidence of port site hernia.