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

RecruitingPhase 4Ages 18 Years - 65 YearsMaleBrazilian Institute of Robotic Surgery
NCT06784986 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • The Conventional Insufflation System
  • AirSeal® System
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Where

2 sites
Instituto Brasileiro de Cirurgia Robotica
Salvador, Brazil
Hospital Mater Dei Salvador
Salvador, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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