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Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
Sponsor: Brazilian Institute of Robotic Surgery
Summary
The AirSeal platform has been evaluated in urological surgeries, mainly in cases of malignant diseases 5,6. However, there is still a lack of data demonstrating the possible benefits of its use, which justifies the conduct of this research in order to aggregate such knowledge. Therefore, the objective of this prospective pilot study is to compare and evaluate the role of low-pressure pneumoperitoneum with the AirSeal system in patients with prostate cancer undergoing robot-assisted prostatectomy with those undergoing the procedure with the conventional insufflation system. We seek to provide more data on the use of AirSeal, which is associated with shorter operative times, shorter hospital stays and a lower probability of complications. In addition, we aim to ratify the effectiveness and cost-benefit of using the AirSeal system.
Key Details
Gender
MALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-02
Completion Date
2026-02-15
Last Updated
2025-01-20
Healthy Volunteers
No
Interventions
The Conventional Insufflation System
The Conventional Insufflation System employs standard CO2 insufflation techniques for maintaining intra-abdominal pressure during laparoscopic and robotic surgeries. It serves as the base for comparison with the AirSeal® System.
AirSeal® System
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple-lumen filtered tube set, and a valve-free trocar (AirSeal® Access Port). This innovative system allows peritoneal access and pneumoperitoneum maintenance without a mechanical seal, reducing CO2 usage and associated complications.
Locations (2)
Instituto Brasileiro de Cirurgia Robotica
Salvador, Estado de Bahia, Brazil
Hospital Mater Dei Salvador
Salvador, Estado de Bahia, Brazil