Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial

Abstract

BACKGROUND: Robot-assisted laparoscopic radical prostatectomy and robot-assisted radical cystectomy have gradually become the preferred choices for urologists as they allow surgeons to perform complex procedures more precisely and effectively. The pneumoperitoneum, which is normally applied in these surgeries to provide visual clarity and space to perform the procedure, may cause hemodynamic disturbance, potentially myocardial injury. Thus surgeons have recently considered opting for the low-pressure pneumoperitoneum to lower this negative impact. Herein we describe a protocol for a clinical trial to compare the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery. METHODS/DESIGN: This study is designed to be a bicenter clinical trial. In total 280 patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy or robot-assisted radical cystectomy will be enrolled and randomized into two groups, with standard- (12-16 mmHg) and low-pressure (7-10 mmHg) pneumoperitoneum, respectively. Troponin T will be measured as the primary endpoint to assess the extent of myocardial injury. Nt-proBNP and hemodynamic indexes will also be recorded for further analysis. DISCUSSION: The significance of this study is emphasized by the fact that there are few studies that have focused on the impact of prolonged pneumoperitoneum on myocardial injury, which is relevant to postoperative mortality. We hope that the conclusions drawn from this study could provide reference and basis to the future of the pneumoperitoneum in clinical practice. TRIAL REGISTRATION: Registered at https://www.clinicaltrials.gov with the Identifier NCT02600481 on November 5, 2015.