Looking for volunteers
Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
NCT06784986 · Brazilian Institute of Robotic Surgery · Updated 20 Jan 2025
- What is being tested
- The Conventional Insufflation System; AirSeal® System
- For
- Prostate Carcinoma; Prostate Neoplasm; Pain Intensity Assessment; Quality of Life (QOL)
- Kind of study
- Tests a treatment or device on volunteers. Phase 4.
- Who can join
- Ages 18 years to 65 years. About 200 people. The full rules are on the registry page.
- Where
- Brazil (2 sites)
- When
- Starts or started Feb 2025, ends 15 Feb 2026. Registered 20 Jan 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Instituto Brasileiro de Cirurgia RoboticaSalvador, Estado de Bahia, Brazil
- Hospital Mater Dei SalvadorSalvador, Estado de Bahia, Brazil