Effectiveness of a reusable low-cost balloon trocar dissection device in the creation of preperitoneal space during endoscopic surgery. An experimental study in swine.

PURPOSE: To evaluate a new, low-cost, reusable balloon trocar device for dissection of the preperitoneal space during endoscopic surgery. METHODS: Twenty swine (weight: 15-37 kg) were randomized to two groups, according to whether the preperitoneal space was created with a new balloon device manufactured by Bhio-Supply (group B) or with the commercially available OMSPDB 1000® balloon device manufactured by Covidien (group C). Quality and size of the created preperitoneal space, identification of anatomic structures, balloon dissection time, total procedure time, balloon resistance and internal pressure after insufflation with 300 mL of ambient air, balloon-related complications, and procedure cost were assessed. RESULTS: No significant differences in dissection time, total procedure time, or size of the created preperitoneal space were found between the groups. Balloons in group B had a significantly higher internal pressure compared to balloons in group C. None of the balloons ruptured during the experiment. Three animals in group C had balloon-related peritoneal lacerations. Despite a higher individual device cost, group B had a lower procedure cost over the entire experiment. CONCLUSION: The new balloon device is not inferior to the commercially available device in terms of the safety and effectiveness for creating a preperitoneal space in swine.