title: A randomized phase II study of the clinical effects of ultrasonically activated coagulating shears (Harmonic scalpel) in open gastrectomy for gastric cancer.
abstract: OBJECTIVE
  The Harmonic Ace ultrasonic scalpel has been popular in abdominal surgery; however, only a few clinical studies have evaluated the efficacy of this device in radical open gastrectomy for gastric cancer.
  
  
  METHODS
  The present study was designed as a multicenter, prospective, randomized, controlled trial. Patients with resectable gastric cancer were randomly assigned to gastrectomy using the Harmonic scalpel or conventional monopolar electrosurgery.
  
  
  RESULTS
  A total of 248 patients were enrolled, and 123 patients were included in the Harmonic group and 114 patients were included in the conventional group. The demographics of the patients were well balanced between the groups. There was no significant difference in the length of the operation from skin incision to resection of the gastric specimen (141 ± 36 min in the Harmonic group vs. 147 ± 13 min in the conventional group; p = 0.276) nor in the amount of blood lost (365 ± 293 vs. 336 ± 272 mL; p = 0.434). There was also no significant difference in the incidence of surgical complications or the post-surgical hospital stay between the groups.
  
  
  CONCLUSIONS
  The Harmonic scalpel procedure was not superior to the conventional monopolar electrosurgery with regard to reducing the length of the operation, blood loss, postoperative complications, or postoperative hospital stay in radical open gastrectomy.
authors.affiliation: Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.|Department of Surgery, Sakai City Hospital, Osaka, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Kawabata
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. stakiguchi@gesurg.med.osaka-u.ac.jp.
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.affiliation: Department of Surgery, Sakai City Hospital, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.affiliation: Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.affiliation: NTT West Osaka Hospital, Osaka, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Fujita
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
authors.affiliation: Department of Surgery, Osaka General Medical Center, Osaka, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fujitani
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Kishi
authors.affiliation: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Fujiwara
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004598:Electrosurgery / Q000295:instrumentation* / Q000379:methods; D023381:Endpoint Determination; D005260:Female; D005743:Gastrectomy / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000601:surgery*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000295:instrumentation* / Q000379:methods; D055815:Young Adult
keywords: Harmonic scalpel; Open gastrectomy; Randomized controlled trial