Clinical Trial

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

Study acronym: ARCO2

Recruiting Phase 4

Record status

This record was last updated January 20, 2025 (before its estimated December 15, 2025 completion). Its status may not reflect the trial's current state.

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.

Trial Details

NCT Number	NCT06784986
Lead Sponsor	Brazilian Institute of Robotic Surgery Collaborators: Hospital Mater Dei Salvador
Conditions	Prostate Carcinoma, Prostate Neoplasm, Pain Intensity Assessment, Quality of Life (QOL)
Enrollment	200 participants
Start Date	2025-02
Primary Completion	2025-12-15 (estimated)
Study Completion	2026-02-15 (estimated)
Updated on ClinicalTrials.gov	2025-01-20