文章基本信息

标题：BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial
本地全文：下载
作者：Jiang-ming Chen ; Wei Geng ; Fu-bao Liu 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2015
卷号：16
期号：1
页码：1
DOI：10.1186/s13063-015-0722-1
语种：English
出版社：BioMed Central
摘要：Background Blood loss and the requirement of blood transfusions during liver transection have been shown to correlate well with higher morbidity and mortality rates and a worse prognosis. Various devices for liver parenchymal transection have been developed to reduce intraoperative blood loss. The goal of this study is to evaluate the safety and effectiveness of BiClamp® forcep transection compared to a clamp crushing technique in patients undergoing liver resection. Methods/Design This study will include patients 18 years and older scheduled for hepatectomy with hepatic vascular exclusion who give informed consent. A sample size of 48 patients in each randomization arm will be calculated to detect a difference in the reduction of blood loss of approximately 200 ml (90% power and α = 0.05 (two-tailed)). The primary efficacy endpoint of the trial will be the total intraoperative blood loss based on the randomized dissection technique. The statistical analysis is based on the intention-to-treat population. Patients will be followed up on for three months for complications and adverse events. Discussion This prospective, single-center, randomized controlled, single-blinded, two-group parallel trial is designed to assess the efficacy and safety of BiClamp forcep hepatectomy versus clamp crushing for parenchymal transection during elective hepatic resection. Trial registration This trial was registered with Clinicaltrials.gov (identifier: NCT02197481 ) on 15 July 2014.
关键词：Clamp crushing ; BiClamp® forcep transection ; Blood loss ; Randomized controlled trial