Impact of Using the Airseal System with Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: a Prospective, Comparative, Randomized Clinical Study.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients with prostate cancer who will undergo robotic prostatectomy;
Locations
Other Locations
Brazil
Hospital Mater Dei Salvador
RECRUITING
Salvador
Instituto Brasileiro de Cirurgia Robotica
RECRUITING
Salvador
Contact Information
Primary
NILO JORGE LEÃO COORDENADOR
ibcrpesquisa@gmail.com
+55 71 2626-3030
Time Frame
Start Date:2025-02
Estimated Completion Date:2026-02-15
Participants
Target number of participants:200
Treatments
Other: Conventional Insufflator and Trocar
Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using a conventional CO2 insufflation system. This system maintains standard intra-abdominal pressure (12-15 mmHg) and is widely used in clinical practice.
Experimental: AirSeal® System-Interventional
Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using the AirSeal® System. The device enables stable pneumoperitoneum at ultra-low pressures (6-8 mmHg), aiming to reduce complications and improve surgical outcomes.