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BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial
- Source :
-
Trials . 2015, Vol. 16 Issue 1, p201-206. 6p. 1 Color Photograph, 1 Diagram, 2 Charts. - Publication Year :
- 2015
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 16
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 108585045
- Full Text :
- https://doi.org/10.1186/s13063-015-0722-1