title: Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device.
abstract: OBJECTIVE
  The Harmonic ACE+7 Shears with Advanced Hemostasis Mode (Ethicon, Somerville, NJ, USA) is an ultrasonic device designed to transect and seal vessels up to 7 mm in diameter. The device applies an algorithm that optimizes ultrasonic energy delivery combined with a longer sealing cycle. The purpose of this study was to assess the initial clinical experience with the Harmonic device by evaluating large-vessel sealing during laparoscopic colectomy in consecutive cases.
  
  
  METHODS
  This prospective, multicenter, observational series involved 40 adult patients who were to undergo elective laparoscopic colectomy where dissection and transection of the inferior mesenteric artery was indicated. The primary study endpoint was first-pass hemostasis, defined as a single activation of the Advanced Hemostasis Mode to transect and seal the inferior mesenteric artery. The use of any additional energy device or hemostatic product to establish or maintain hemostasis was noted. Patients were observed after surgery for ∼4 weeks for adverse events that were considered to be related to the study procedure or study device. Descriptive statistical analyses were performed for study endpoints.
  
  
  RESULTS
  Forty patients underwent the laparoscopic colectomy procedure. First-pass hemostasis of the inferior mesenteric artery was achieved and maintained in all 40 patients, with no required additional hemostatic measures. Exposure of the vessel was reported as skeletonized in 22 of 40 (55%) patients. Mean transection time was 21.9 ± 7.4 s. One adverse event (postoperative anemia) was considered possibly related to the study device.
  
  
  CONCLUSIONS
  In this initial clinical consecutive series, the device demonstrated successful transection and sealing of the large mesenteric vessels during laparoscopic colorectal surgery.
authors.affiliation: Department of Surgery, Jackson Health System, Miami, Florida, USA.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Plasencia
authors.affiliation: Department of Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.
authors.forename: Kurt
authors.initials: K
authors.lastname: Van der Speeten
authors.affiliation: Medical Affairs, Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Piet
authors.initials: P
authors.lastname: Hinoul
authors.affiliation: Clinical Development, Ethicon Endo-Surgery, Cincinnati, OH, USA.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Kelch
authors.affiliation: Clinical Development, Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Batiller
authors.affiliation: Clinical Development, Ethicon Endo-Surgery, Cincinnati, OH, USA.
authors.forename: Kimberley S
authors.initials: KS
authors.lastname: Severin
authors.affiliation: Clinical Development, Ethicon Endo-Surgery, Cincinnati, OH, USA.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Schwiers
authors.affiliation: Department of Surgery, The Royal Surrey County Hospital, Surrey, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Rockall
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003082:Colectomy / Q000295:instrumentation* / Q000379:methods; D005260:Female; D016558:Hemostasis, Endoscopic / Q000295:instrumentation*; D006801:Humans; D010535:Laparoscopy / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D025321:Surgery, Computer-Assisted / Q000295:instrumentation*; D059708:Ultrasonic Surgical Procedures / Q000295:instrumentation*
keywords: Colectomy; Colorectal surgery; Hemostasis; Inferior mesenteric artery