Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal®

Abstract

Background AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO 2 recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO 2 insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO 2 insufflators in patients undergoing the most frequently performed laparoscopic procedures. Methods One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO 2 insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay. Results Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay. Conclusion This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO 2 insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).

Impact of insufflator/aspirator versus exclusive insufflator during robotic radical prostatectomy: a comparative prospective cohort study

“…Luketina et al 10 . showed in an randomized clinical trial (RCT) that the use of the AirSeal® system in cholecystectomy, colorectal surgery, and hernia repair did not reduce operative time and was associated with higher postoperative shoulder pain compared to standard CO 2 insufflator.…”

Using LAP PROTECTOR™ to prevent subcutaneous emphysema after robotic gastrectomy

“…Because RG is standardized to be performed with ve ports, other means must be considered for minimizing the risk of SE. The valveless insu ation system, AirSeal®, is becoming increasingly popular in robotic surgery because it maintains a stable-pressure pneumoperitoneum and performs continuous smoke evacuation [17,18]. However, the use of this device is also known to increase the risk of SE [15].…”

Use of current automatic smoke evacuation system in flexible gastrointestinal endoscopy: Its feasibility and potential usefulness

“…The surgical smoke generated by the energy‐based devices in flexible gastrointestinal (GI) endoscopic procedures, such as endoscopic submucosal dissection, obstructs the field of view and usually requires repeated manual suctions and insufflations by endoscopists 3–8 . In contrast, laparoscopic surgery already has systems that can automatically evacuate the smoke in the abdominal cavity, 9–11 and it has already been reported, including ours, that the automatic smoke evacuator provides a better field‐of‐view and further reduces the risk of exposure to harmful compounds, including carcinogenic substances 12–15 . Other reports have shown that surgical smoke contains viruses such as human papillomavirus, and the use of smoke evacuators is recommended for laser surgery 16,17 .…”