文章基本信息

标题：LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial
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作者：Tobias Gehrig ; Phillip Knebel ; Verena Scheel 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2011
卷号：12
期号：1
页码：162
DOI：10.1186/1745-6215-12-162
语种：English
出版社：BioMed Central
摘要：The pp-Whipple procedure requires extensive preparation. The conventional preparation technique is done with scissors for dissection and ligatures, and with clips and sutures for hemostasis. This procedure is very time-consuming and requires numerous changes of instruments. The LigaSure™ device allows dissection and hemostasis for preparation with one instrument. Up to now there has been no comparison of the two techniques with regard to operating time and the patients' outcome. It is still unclear which technique has the optimal benefit/risk ratio for the patient. A single-center, randomized, single-blinded, controlled superiority trial to compare two different techniques for dissection in a pp-Whipple procedure. 102 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective pp-Whipple procedure who signed the informed consent will be included. The primary endpoint is the operating time of the randomized technique. Control Intervention: Conventional dissection technique; experimental intervention: LigaSureTM dissection technique. Duration of study: Approximately 15 months; follow up time: 3 years. The trial is registered at German ClinicalTrials Register (DRKS00000166).
关键词：Dissection Technique ; Bipolar Vessel ; Electrothermal Bipolar Vessel Sealant ; Bipolar Vessel Sealant ; Case Report File