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 trialReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 17:488

First Online: 10 October 2016Received: 06 December 2015Accepted: 17 September 2016DOI: 10.1186-s13063-016-1609-5

Cite this article as: Zhang, X., Wei, J., Song, X. et al. Trials 2016 17: 488. doi:10.1186-s13063-016-1609-5

Abstract

BackgroundRobot-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-designThis 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.

DiscussionThe 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 registrationRegistered at https:-www.clinicaltrials.gov with the Identifier NCT02600481 on November 5, 2015

KeywordsLow-pressure pneumoperitoneum Standard-pressure pneumoperitoneum Myocardial injury Troponin T Trendelenburg position Robot-assisted urological surgery AbbreviationsIAPIntra-abdominal pressure

LPPLow-pressure pneumoperitoneum

QTcdCorrected QT dispersion

RALRPRobot-assisted laparoscopic radical prostatectomy

RARCRobot-assisted radical cystectomy

SPPStandard-pressure pneumoperitoneum

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1609-5 contains supplementary material, which is available to authorized users.





Autor: Xixue Zhang - Jionglin Wei - Xiaoxing Song - Yuhao Zhang - Weiqing Qian - Lu Sheng - Zhoujun Shen - Lvjun Yang - Rong Don

Fuente: https://link.springer.com/







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