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Open Access 01-07-2021 | Cholecystectomy

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

Authors: Rosalia Luketina, Theodore L. H. Luketina, Stavros A. Antoniou, Gernot Köhler, Sören Könneker, Lisa Manzenreiter, Helwig Wundsam, Oliver Owen Koch, Michael Knauer, Klaus Emmanuel

Published in: Surgical Endoscopy | Issue 7/2021

Abstract

Background

AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO₂ recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO₂ insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO₂ 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 CO₂ 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 CO₂ insufflator for short elective surgeries.

ClinicalTrials.gov (NCT01740011).

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Title: Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal®
Authors: Rosalia Luketina
Theodore L. H. Luketina
Stavros A. Antoniou
Gernot Köhler
Sören Könneker
Lisa Manzenreiter
Helwig Wundsam
Oliver Owen Koch
Michael Knauer
Klaus Emmanuel
Publication date: 01-07-2021
Publisher: Springer US
Keyword: Cholecystectomy
Published in: Surgical Endoscopy / Issue 7/2021
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-020-07846-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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