We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.
- Authors
Jiang-ming Chen; Wei Geng; Fu-bao Liu; Hong-chuan Zhao; Sheng-xue Xie; Hui Hou; Yi-jun Zhao; Guo-bin Wang; Xiao-ping Geng
- Abstract
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.
- Subjects
ABDOMEN; ANATOMY; VISCERA; LIVER; BILIARY tract; RANDOMIZED controlled trials
- Publication
Trials, 2015, Vol 16, Issue 1, p1
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/s13063-015-0722-1