Comparison of a standard CO2 pressure pneumoperitoneum insufflator versus AirSeal™: study protocol of a randomized controlled trial

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.

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

“…Results are presented according to the CONSORT statement (Supplemental Digital Content 1, https://links.lww.com/SLA/B352 ) [ 13 ]. The study protocol has been published previously [ 14 ].…”

“…Statistical analysis was performed using the open-source R statistical software package, version 3.0.1. The detailed sample size estimation and hypothesis have been published previously in our study protocol [14].…”

Ligation-free technique for dorsal vascular complex control during laparoscopic radical prostatectomy: a single-center experience from China

“…To avoid carbon dioxide intoxication, we normally did not raise the pneumoperitoneum pressure. We believe that will burden a relative risk of cardiopulmonary function on patients, which could also influence the postoperative recovery [5,6]. Finally, a running vesicourethral anastomosis is achieved by using a 2 X T4 taper, 14 cm × 14 cm, double-armed barbed suture (Quill™ SRS, Angiotech, Reading, PA) and the Van Velthoven technique [7].…”

Endosocopic Device for Surgeries in Experimnetal Animals

“…Створено новий клас обладнання для ін-суфляції, яке зменшує обсяги використання газу, що вводиться і відразу реагує на незнач-ні зміни внутрішньочеревного тиску [6]. Ці апарати спрямовані на підтримку стабільного карбоксиперитонеуму і забезпечують безпе-рервне вилучення диму навіть у складних хірургічних умовах, створюючи при цьому достатню видимість.…”