Actively Recruiting
Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
Led by Brazilian Institute of Robotic Surgery · Updated on 2025-01-20
200
Participants Needed
2
Research Sites
54 weeks
Total Duration
On this page
Sponsors
B
Brazilian Institute of Robotic Surgery
Lead Sponsor
H
Hospital Mater Dei Salvador
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with prostate cancer who will undergo robotic prostatectomy
You will not qualify if you...
- Patients over 65 and under 18 years of age
- Patients allergic to NSAIDs and/or Morphine and/or Tramadol
- Patients with chronic renal failure
- Patients with recurrence, metastasis and other existing neoplasms
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Instituto Brasileiro de Cirurgia Robotica
Salvador, Estado de Bahia, Brazil, 43017030
Actively Recruiting
2
Hospital Mater Dei Salvador
Salvador, Estado de Bahia, Brazil
Actively Recruiting
Research Team
N
NILO JORGE LEÃO COORDENADOR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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