Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Prostatic Neoplasms

Pneumoperitoneum

Peritoneal Diseases

Gastrointestinal Diseases

A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Pneumoperitoneum Pressure 6 mmHg

A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Pneumoperitoneum Pressure 15 mmHg

Ronney Abaza, MD

The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.

Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)

Ultralow Versus Standard Pneumoperitoneum Pressure

Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System

The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.

The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant

CONMED Corporation

OhioHealth

Pneumoperitoneum Pressure 6 mmHg

Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.

Pressure 6 mmHg

Pneumoperitoneum Pressure 15 mmHg

Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.

Pressure 15 mmHg

Pneumoperitoneum Pressure 6 mmHg

Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.

Pneumoperitoneum Pressure 15 mmHg

Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Dr. Ryan Hedgepeth

Postoperative Pain Medication Use

Post-operative pain scores were not recorded for one participant in the Pneumoperitoneum pressure 6 mmHg group

Post Operative Pain Scores

Operative Ventilation

The post-operative discharge day was not recorded for one participant in each group

Spots Global Cancer Trial Database for pneumoperitoneum pressure 6 mmhg