Comparison of a standard CO(2) pressure pneumoperitoneum insufflator versus AirSeal™: study protocol of a randomized controlled trial

BACKGROUND: AirSeal™ is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO(2)) recirculation during laparoscopic surgery. Comparison data to standard CO(2) pressure pneumoperitoneum insufflators is scarce. The aim of this study is to evaluate the potential advantages of AirSeal™ compared to a standard CO(2) insufflator. METHODS/DESIGN: This is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair with AirSeal™ (group A) versus a standard CO(2) 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). DISCUSSION: The duration of an operation is an important factor in reducing the patient’s exposure to CO(2) 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 REGISTRATION: ClinicalTrials.gov NCT01740011, registered 23 November 2012.