title: Prospective randomized comparison of conventional instruments and the Harmonic Focus(®) device in breast-conserving therapy for primary breast cancer.
abstract: BACKGROUND
  In recent years, surgeons have utilized Harmonic instruments to perform breast cancer resection. Retrospective and prospective studies have demonstrated that the use of this surgical device for mastectomy and axillary dissection can reduce perioperative blood loss, seroma formation, and duration and total amount of drainage. No study has analyzed the feasibility of Harmonic instruments in breast-conserving surgery. We conducted a prospective, randomized clinical trial comparing Harmonic instrument and conventional surgery in the performance of breast-conserving surgery and axillary procedures to determine differences in surgical procedures, postoperative outcome, and complications.
  
  
  METHODS
  One hundred and six patients with operable breast cancer who underwent breast-conserving surgery at a single institution between December 2009 and January 2011 were included in the analysis. Surgery was performed in 52 patients with the Harmonic Focus(®) device and in 54 with scissors and electrocautery. This study focused on operative time, drainage volume, and postoperative outcome measures like blood loss, surgery related complications and patient-reported postoperative pain.
  
  
  RESULTS
  We found a multivariable independent influence in axillary seroma formation and volume of breast drainage with HS. Evident difference in volume and duration of axillary and breast drainage, subjective and objective postoperative pain, reduction in serum hemoglobin, size and weight of resected breast tissue and length of hospital stay in favor of the Harmonic instrument could also be shown.
  
  
  CONCLUSIONS
  The Harmonic instrument provides key benefits in surgical technique, postoperative outcome, and complication rates in breast cancer surgery.
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany. daniel.boehm@unimedizin-mainz.de
authors.forename: D
authors.initials: D
authors.lastname: Böhm
authors.forename: A
authors.initials: A
authors.lastname: Kubitza
authors.forename: A
authors.initials: A
authors.lastname: Lebrecht
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
authors.forename: A
authors.initials: A
authors.lastname: Gerhold-Ay
authors.forename: M
authors.initials: M
authors.lastname: Battista
authors.forename: K
authors.initials: K
authors.lastname: Stewen
authors.forename: C
authors.initials: C
authors.lastname: Solbach
authors.forename: H
authors.initials: H
authors.lastname: Kölbl
mesh_terms: D000046:Academic Medical Centers; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016009:Chi-Square Distribution; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D016015:Logistic Models; D015412:Mastectomy, Segmental / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000473:pathology* / Q000628:therapy; D009367:Neoplasm Staging; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications / Q000503:physiopathology; D011446:Prospective Studies; D018570:Risk Assessment; D049291:Seroma / Q000209:etiology / Q000628:therapy; D018709:Statistics, Nonparametric; D013525:Surgical Instruments; D016019:Survival Analysis; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000295:instrumentation* / Q000379:methods