RecruitingPhase 4NCT06784986

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

Sponsor

Brazilian Institute of Robotic Surgery

Enrollment

200 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Quality of Life (QOL)Prostate Carcinoma Prostate Neoplasm Pain Intensity Assessment

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

Sex: MALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for men undergoing robotic surgery to remove the prostate for cancer. One group will use a special gas management system (AirSeal) with very low abdominal pressure, and the other will use a standard approach. Researchers want to see if the lower pressure system reduces pain and improves recovery. **You may be eligible if...** - You have prostate cancer and are scheduled for robotic prostatectomy (surgical removal of the prostate) - You are between 18 and 65 years old **You may NOT be eligible if...** - You are over 65 or under 18 years old - You are allergic to NSAIDs (like ibuprofen), morphine, or tramadol - You have chronic kidney failure - Your cancer has spread (metastases) or you have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe 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.

DEVICEAirSeal® 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.

Locations(2)

Instituto Brasileiro de Cirurgia Robotica

Salvador, Estado de Bahia, Brazil

Hospital Mater Dei Salvador

Salvador, Estado de Bahia, Brazil

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