title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
authors.affiliation: Department of General, Abdominal and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. tobias.gehrig@med.uni-heidelberg.de
authors.forename: Tobias
authors.initials: T
authors.lastname: Gehrig
authors.forename: Phillip
authors.initials: P
authors.lastname: Knebel
authors.forename: Verena
authors.initials: V
authors.lastname: Scheel
authors.forename: Ulf
authors.initials: U
authors.lastname: Hinz
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
authors.forename: Beat P
authors.initials: BP
authors.lastname: Müller-Stich
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Carsten N
authors.initials: CN
authors.lastname: Gutt
mesh_terms: D004210:Dissection / Q000009:adverse effects / Q000295:instrumentation; D004867:Equipment Design; D005858:Germany; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D008026:Ligation; D010190:Pancreatic Neoplasms / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D012107:Research Design; D016037:Single-Blind Method; D013523:Surgical Equipment; D013997:Time Factors; D016896:Treatment Outcome