A Prospective Randomized Trial on comparison of standard CO2 Pressure Pneumoperitoneum Insufflators versus AirSeal®

Abstract

Background The insufflation system is one of the most significant components of laparoscopic surgery procedures. Standard CO2 insufflators are being replaced by Airseal® insufflators, which are valveless and allow continuous smoke evacuation. It is also believed that AirSeal® insufflators maintain the stability of the pneumoperitoneum. However, little experimental data comparing the two insufflating systems are available. A randomized controlled trial was conducted to compare these two systems. This study used the data from this trial to understand and explain the relationship between laparoscopy and postoperative shoulder tip pain. Methods A total of 198 patients were randomly allocated into AirSeal® (Group A) and Standard CO2 insufflation (Group S). These patients were selected to undergo laparoscopic cholecystectomy, colorectal surgery, or hernia repair. The study’s primary aims were to investigate the operative time of different surgeries and the postoperative shoulder tip pain associated with laparoscopy. The secondary objectives were determining Clavien-Dindo grade complications, side effects, and postoperative hospital time. Results Group A contained 101 patients (n = 101), and Group S included 97 patients (n = 97). Data from the different surgical procedures were analyzed on an intention-to-treat basis. After analyzing the data, no significant difference was observed in the average surgery time (median Interquartile Range [IQR]; 71 min [56–94] in Group A vs. 69 min [52–93] in Group S; p = 0.434). The analysis of visual analog scale (VAS) data revealed that shoulder tip pain was reported more frequently in patients operated on using the AirSeal® system than in those operated on using the standard CO2 insufflator (VAS 0 [0–3] in Group S vs. 2 [0–4] in Group A; p = 0.001). No complications or other side effects were reported in either group's laparoscopic surgeries. There was no difference in mean hospital time for both groups. Conclusion Examining the data from this randomized trial revealed that the AirSeal® Insufflation system does not prolong surgery time. It was also found that AirSeal® resulted in more postoperative shoulder tip pain than standard insufflation, particularly for shorter surgeries. ClinicalTrials.gov (NCT01740011).

Datum der Bewilligung	2026
Originalsprache	Englisch
Gradverleihende Hochschule	Medizinische Universität Graz
Betreuer/-in	Igor Knez (Betreuer*in)