Abstract
BackgroundAirSeal™ is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO2) recirculation during laparoscopic surgery. Comparison data to standard CO2 pressure pneumoperitoneum insufflators is scarce. The aim of this study is to evaluate the potential advantages of AirSeal™ compared to a standard CO2 insufflator.Methods/DesignThis is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair with AirSeal™ (group A) versus a standard CO2 pressure insufflator (group S). Patients are randomized using a web-based central randomization and registration system. Primary outcome measures will be operative time and level of postoperative shoulder pain by using the visual analog score (VAS). Secondary outcomes include the evaluation of immunological values through blood tests, anesthesiological parameters, surgical side effects and length of hospital stay. Taking into account an expected dropout rate of 5%, the total number of patients is 182 (n = 91 per group). All tests will be two-sided with a confidence level of 95% (P <0.05).DiscussionThe duration of an operation is an important factor in reducing the patient’s exposure to CO2 pneumoperitoneum and its adverse consequences. This trial will help to evaluate if the announced advantages of AirSeal™, such as clear sight of the operative site and an exceptionally stable working environment, will facilitate the course of selected procedures and influence operation time and patients clinical outcome.Trial registrationClinicalTrials.gov NCT01740011, registered 23 November 2012.
Highlights
AirSealTM is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO2) recirculation during laparoscopic surgery
The duration of an operation is an important factor in reducing the patient’s exposure to Carbon dioxide (CO2) pneumoperitoneum and its adverse consequences. This trial will help to evaluate if the announced advantages of AirSealTM, such as clear sight of the operative site and an exceptionally stable working environment, will facilitate the course of selected procedures and influence operation time and patients clinical outcome
The absorption of CO2 during pneumoperitoneum can lead to an increase in Arterial carbon dioxide partial pressure (PaCO2) level, hypercapnia is commonly avoided by appropriate ventilatory changes
Summary
AirSealTM is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO2) recirculation during laparoscopic surgery. Laparoscopic surgery is currently actively used in a variety of surgical conditions and is performed through the creation of a workspace between the abdominal wall and the internal organs, most commonly by the insufflation of carbon dioxide (CO2) to the level of positive intraabdominal pressure tolerated by the patient. Many physiological changes of laparoscopic surgery have recently been reported in research articles [6,7,8]. To examine changes in the concentrations of certain cytokines and angiogenic factors serum levels in the early postoperative period after laparoscopic surgery further studies are needed. The absorption of CO2 during pneumoperitoneum can lead to an increase in PaCO2 level, hypercapnia is commonly avoided by appropriate ventilatory changes. The increased intra-abdominal pressure during pneumoperitoneum can reduce femoral venous flow, intraoperative urine output, portal venous flow, respiratory compliance and cardiac output [3]
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