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

Condition(s) studied

Investigational drug(s) / intervention(s)

The Conventional Insufflation System: The 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: The 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.

Study summary

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

Primary outcome measure(s)

• Variance in Intra-abdominal Pressure with the AirSeal System — Day 1 (Day of Procedure)
  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.

Trial sites (2)

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