eprintid: 25136
rev_number: 12
eprint_status: archive
userid: 1589
dir: disk0/00/02/51/36
datestamp: 2018-07-23 09:50:43
lastmod: 2024-05-24 23:19:02
status_changed: 2018-07-23 09:50:43
type: article
metadata_visibility: show
creators_name: Houben, Philipp
creators_name: Khajeh, Elias
creators_name: Hinz, Ulf
creators_name: Knebel, Phillip
creators_name: Diener, Markus K.
creators_name: Mehrabi, Arianeb
title: Sealive: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial
subjects: ddc-610
divisions: i-850300
divisions: i-910100
abstract: Background: The surgical technique used in liver transplantation has undergone constant evolution in an effort to develop a safe, highly standardized procedure. Despite this, the initial step of recipient hepatectomy has not been the focus of clinical research thus far. Due to advanced coagulopathy in liver transplant recipients, this part of the operation still carries the risk of severe hemorrhage. This trial is designed to compare an electrothermal bipolar vessel sealing device (LigaSure™) and an ultrasound dissector (HARMONIC ACE®+7) with standard surgical techniques during the recipients’ hepatectomy in liver transplantation.

Methods/design: In a single-center, prospective, randomized, controlled, parallel, three-armed, confirmatory, open trial, LigaSure™ and HARMONIC ACE®+7 will be compared with standard surgical techniques that use titanium clips and conventional knot-tying ligations during recipient hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, and blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites, and by weighing used swabs. At 80% power and an alpha of 0.025 for both of the experimental groups, 23 subjects will be analyzed per protocol in each study arm in order to detect clinically relevant reduction of intraoperative blood loss. The intention-to-treat analysis will include 69 patients. The follow-up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first 10 postoperative days.

Discussion: To our knowledge, this is the first prospective, randomized trial comparing two innovative technical methods of vessel sealing and dissection with standard techniques for recipient hepatectomy. This will be done to detect relevant reduction of intraoperative blood loss during liver transplant. The results of the trial are expected to improve patient outcome and safety after liver transplant and to increase the general safety of this procedure.

Trial registration: ClinicalTrials.gov, NCT 03323242  . Registered on October 26, 2017.
date: 2018
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1655797956
own_urn: urn:nbn:de:bsz:16-heidok-251363
language: eng
bibsort: HOUBENPHILSEALIVETHE2018
full_text_status: public
publication: Trials
volume: 19
number: 380
place_of_pub: London
pagerange: 1-10
issn: 1468-6694
citation:   Houben, Philipp ; Khajeh, Elias ; Hinz, Ulf ; Knebel, Phillip ; Diener, Markus K. ; Mehrabi, Arianeb  (2018) Sealive: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial.  Trials, 19 (380).  pp. 1-10.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/25136/1/13063_2018_Article_2778.pdf