Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
Recruiting · NCT06784986 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Patients with prostate cancer who will undergo robotic prostatectomy;
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Instituto Brasileiro de Cirurgia Robotica - Salvador, Estado de Bahia, Brazil
- Hospital Mater Dei Salvador - Salvador, Estado de Bahia, Brazil