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

PHASE4RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

December 15, 2025

Study Completion Date

February 15, 2026

Conditions
Prostate CarcinomaProstate NeoplasmPain Intensity AssessmentQuality of Life (QOL)
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (2)

43017030

RECRUITING

Instituto Brasileiro de Cirurgia Robotica, Salvador

Unknown

RECRUITING

Hospital Mater Dei Salvador, Salvador

All Listed Sponsors
collaborator

Hospital Mater Dei Salvador

UNKNOWN

lead

Brazilian Institute of Robotic Surgery

OTHER