Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device

The aim of this study was to evaluate and compare a novel trocars-site closure device, the WECK EFx™ Endo Fascial Closure System (EFx) with the Carter-Thomason CloseSure System® (CT) for the closure of laparoscopic trocar site defects created by a 12-mm dilating trocar.

We created standardized laparoscopic trocars-site abdominal wall defects in cadaver models using a standard 12-mm laparoscopic dilating trocar. Trocar defects were closed in a randomized fashion using one of the two closure systems. We recorded time and number of attempts needed for complete defect closure. In addition, we recorded the ability to maintain pneumoperitoneum, endoscopic visualization, safety, security, and facility based on the surgeon's subjective evaluations. We compared outcomes for the EFx and CT closure systems.

We created 72 standardized laparoscopic trocars-site abdominal wall defects. The mean time needed for complete defect closure was 98.53 seconds (±28.9) for the EFx compared with 133.61 seconds (±54.61) for the CT (P<0.001). The mean number of attempts needed to achieve complete defect closure were 1.19 (1-3) for the EFx and 1.19 (1-2) for the CT (P=0.50). Mean scores for safety were 2.92 for EFx vs 2.19 for CT (P<0.001). Mean scores for facility were 2.97 vs 1.83 for EFx and CT, respectively (P<0.001). Mean scores for maintenance of pneumoperitoneum were 1.97 for EFx vs 2.33 for CT (P=0.022). No significant difference was observed between the EFx and the CT systems for endoscopic visualization (2.28 vs 2.50, P=0.080).

In this in vitro cadaver trial, the EFx was superior in terms of time needed to complete defect closure, safety, and facility. CT was superior in terms of maintenance of pneumoperitoneum. Both systems were equal in the number of attempts needed to complete the defect closure and endoscopic visualization.