Background: The FloShield Air System® is a new device for laparoscopic surgery that utilizes a continuous dry CO2 gas flow over the scope to defog the lens and protect it from condensation, debris and smoke. We set out to compare the performance and efficiency of the device in terms of operative lens vision quality (OLVQ) with the reference technique (water + povidone-iodine (PVI) solution) during gynecologic laparoscopic surgery.
Materials and methods: We conducted a single-center randomized prospective study between March and June 2016 (Trials Database Registration NCT02702531) including 53 patients undergoing gynecologic laparoscopic surgery with water + PVI solution and 51 patients who underwent surgical procedures with the FloShield Air System. The primary outcome measure was the number of laparoscope removals during surgery. Secondary outcome measures were the time to clean, assessment of the quality of vision, the correlation between the laparoscopic surgical complexity and outcomes, and cost effectiveness.
Results: Overall, the mean patient age was 43.2 years (range 22-86) and body mass index 24.8 (range 16.8-42.7). The mean number of endoscope removals during surgery was 7.0 (range 0-37) in the water + PVI solution arm and 2.8 (range 0-12) in the FloShield Air System® arm. The number of removals was significantly lower in the FloShield arm (p < 0.001). No difference in time to clean, quality of vision, level of laparoscopic procedure complexity, or cost was observed between the groups.
Conslusions: The FloShield Air System® resulted in fewer laparoscopic lens removals than the water + PVI solution solution, but that there was no difference in quality of vision, cleaning time or cost, especially for the more complex surgery.
Keywords: Gynecologic endoscopic surgery; Lens vision quality; Randomized trial.