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.
Patients with prostate cancer who will undergo robotic prostatectomy;
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.
Parallel
The Conventional Insufflation System
DeviceThe Conventional Insufflation System employs standard CO2 insufflation techniques for maintaining intra-abdominal pressure during laparoscopic and robotic surgeries. It serves as the base for comparison with the AirSeal® System.
AirSeal® System
DeviceThe AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple-lumen filtered tube set, and a valve-free trocar (AirSeal® Access Port). This innovative system allows peritoneal access and pneumoperitoneum maintenance without a mechanical seal, reducing CO2 usage and associated complications.
Variance in Intra-abdominal Pressure with the AirSeal System
The primary aim of this study is to compare the variance in intra-abdominal pressure (IAP) during robotic-assisted radical prostatectomy between patients using the AirSeal System and those using a conventional CO2 insufflation system. The AirSeal System is expected to provide a more stable IAP at ultra-low pressures (6-8 mmHg) compared to the standard pressures (12-15 mmHg) maintained by the conventional insufflator.
Reduction in Blood Loss with the AirSeal System
This study will measure the total blood loss during the surgical procedure in patients using the AirSeal System versus those using the conventional insufflation system. Lower blood loss is hypothesized with the AirSeal System due to better surgical visibility and lower pressure variability.
Length of Hospital Stay
The length of hospital stay will be recorded for all participants. Patients using the AirSeal System are expected to have a shorter hospital stay due to reduced complications and better recovery.
Incidence of Postoperative Complications
Postoperative complications, including paralytic ileus, respiratory issues, and other adverse events, will be compared between the two groups. The AirSeal System is hypothesized to lower the incidence of these complications.
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Brazilian Institute of Robotic Surgery
Lead sponsor
Hospital Mater Dei Salvador
Collaborator
