Impact of the AirSeal System With Ultra-low Pneumoperitoneum Compared to Conventional Insufflation in Robot-assisted Radical Prostatectomy for Prostate Cancer: A Prospective, Randomized Clinical Study

What this Trial Is About

Researchers are investigating the use of the AirSeal system with ultra-low pneumoperitoneum pressure in patients with prostate cancer undergoing robot-assisted radical prostatectomy. This prospective, randomized clinical study aims to compare the AirSeal system to the conventional insufflation system, assessing potential benefits such as shorter surgical times, reduced hospital stays, fewer complications, and cost-effectiveness. The study focuses on patients with prostate cancer, a group often presenting with comorbidities where lower intra-abdominal pressure during surgery is important. The study involves two groups: one undergoing surgery with the standard CO2 insufflation system and the other using the AirSeal system, which provides a stable pneumoperitoneum without a mechanical seal and reduces CO2 usage. Both groups will receive robot-assisted prostatectomy with either the conventional insufflation or the AirSeal system. The study will last about one year and will be conducted in a private institution. Patients will be randomized equally to either group using sealed envelopes to ensure unbiased allocation. Participants will be monitored through various assessments including console time, blood loss, intra-abdominal pressure, and surgical complications during the procedure. Postoperative evaluations include pain assessment using verbal numeric scales every 6 hours for 48 hours, weekly pain questionnaires, opioid use tracking, and quality of life questionnaires one week after surgery. Pain management will follow a standardized protocol. Safety and postoperative outcomes like hospital stay length, ileus presence, and ambulation will also be recorded. The primary outcome measured is the variance in intra-abdominal pressure on the day of surgery.

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