Ruzica-Rosalia Luketina, MD1, Michael Knauer, MD, PhD2, Hrvoje Luketina3, Oliver Owen Koch, MD, PhD1, Gernot KOhler1, Klaus Emmanuel, Prof, MD1. 1Sisters of Charity Hospital Linz, 2Kantonsspital St. Gallen, 3Charite Medical University Berlin
Aims: AirSeal® is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO2 recirculation during laparoscopic surgery. Comparison data to standard CO2 pressure pneumoperitoneum insufflators is scarce. The aim of this study was to evaluate potential advantages of AirSeal® compared to a standard CO2 insufflator.
Methods: Between January 2013 and January 2014, patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized using a web-based randomization system to the AirSeal® (group A) or standard pressure CO2 insufflator (group S) approach. Primary outcome measures were operative time and level of postoperative shoulder-tip pain by using the visual analog score (VAS). Secondary outcomes were the evaluation of immunological values through blood tests, anaesthesiological parameters, surgical side effects and length of hospital stay.
Results: A total of 198 patients were randomized into group A (n =101) and group S (n = 97). There was no difference between the two groups regardless regarding indication for operation. Five patients in group A and no patients from group S were converted to an open procedure (p=0.06). There was no significant difference in operative time (80.82 ± 36.38 group A vs. 80.33 ± 43.59 group S, p=0.434). The VAS for pain was significantly lower in the group S on first postoperative day compared with the group A (1.14 ± 1.93 vs. 2.28 ± 2.55, p = 0.001). There was a significant difference in postoperative tidal volume and respiratory minute volume between the groups (p=0.013; p=0.025). There was no significant difference in length of hospital stay and surgical side effects.
Conclusion: In this first randomized trial, AirSeal® had no advantages regarding operating time and was not superior regarding shoulder-tip pain in laparoscopic surgery compared to standard CO2 insufflators. Therefore we cannot recommend AirSeal® for elective surgical procedures to replace standard CO2 insufflation systems.
Registration number: NCT01740011 (http://www.clinical trials.gov)