Department Hand, Plastic, Reconstructive and Burn Surgery, BG Trauma Center Tuebingen, Eberhard Karls University Tuebingen, Schnarrenbergstr. 95, 72076, Tuebingen, Germany.
Department of Anaesthesia & Intensive Care Medicine, Cantonal Hospital of Muensterlingen, Muensterlingen, Switzerland.
Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO insufflators in patients undergoing the most frequently performed laparoscopic procedures.
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 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.
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.
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 insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).
AirSeal® 是一种无阀式注气系统，可在腹腔镜手术中实现稳定的气腹，同时持续排烟和 CO 再循环。关于 AirSeal® 和标准 CO 注气器在腹腔镜普通外科手术中的应用比较证据很少。本研究旨在比较 AirSeal® 和标准 CO 注气器在接受最常进行的腹腔镜手术的患者中的手术结果。
198 例择期行腹腔镜胆囊切除术、结直肠手术和疝修补术的患者被随机分为 AirSeal® 组（A 组）或标准压力 CO 注气器组（S 组）。主要终点是手术时间和术后肩痛程度（视觉模拟评分）。次要结果包括 Clavien-Dindo 分级并发症、手术副作用和住院时间。
患者被随机分为 A 组（n=101）或 S 组（n=97），并按意向治疗进行分析。两组的平均手术时间无显著差异（中位数[IQR]；A 组 71 分钟[56-94] vs. S 组 69 分钟[52-93]；p=0.434）。S 组的肩痛程度明显较低（S 组 VAS 0[0-3] vs. A 组 2[0-4]；p=0.001）。两组并发症、手术副作用（无皮下气肿）和住院时间无显著差异。
这项随机对照试验表明，与标准 CO 注气器相比，使用 AirSeal® 系统不会缩短手术时间，并且与术后肩部疼痛较高相关，用于短期择期手术。ClinicalTrials.gov（NCT01740011）。
