Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-65
SponsorBrazilian Institute of Robotic Surgery

About this trial

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 criteria

Qualifiers

Patients with prostate cancer who will undergo robotic prostatectomy;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • The Conventional Insufflation System
  • AirSeal® System

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Brazilian Institute of Robotic Surgery

Lead sponsor

Hospital Mater Dei Salvador

Collaborator