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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Xixue Zhang, Jionglin Wei, Xiaoxing Song, Yuhao Zhang, Weiqing Qian, Lu Sheng, Zhoujun Shen, Lvjun Yang, Rong Dong, Weidong Gu

Published in: Trials | Issue 1/2016

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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
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Xixue Zhang
Jionglin Wei
Xiaoxing Song
Yuhao Zhang
Weiqing Qian
Lu Sheng
Zhoujun Shen
Lvjun Yang
Rong Dong
Weidong Gu
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1609-5

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