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Comparing the Utility and Surgical Outcomes of Harmonic Focus Ultrasonic Scalpel with Ligasure Small Jaw Bipolar Device in Thyroidectomies: A Prospective Randomized Controlled Trial

  • Shen-Han Lee
  • Thien Khanh Nguyen
  • Whee-Sze Ong
  • Benjamin Haaland
  • Gerald Ci-An Tay
  • Ngian Chye Tan
  • Hiang Khoon Tan
  • Jeremy Chung Fai Ng
  • N. Gopalakrishna IyerEmail author
Endocrine Tumors

Abstract

Background

Ultrasonic or bipolar radiofrequency energy devices are routinely used for dissection and hemostasis during thyroidectomy. We report a single-center, prospective, randomized controlled trial comparing the utility and outcomes of Harmonic Focus, an ultrasonic coagulating shear device (UCSD), versus Ligasure Small Jaw, an electrothermal bipolar vessel sealer (EBVS) in thyroidectomy (NCT01765686).

Methods

Between December 2012 to January 2016, eligible patients were randomized to undergo hemithyroidectomy using either a UCSD or an EBVS. The primary outcome was duration of surgery. Secondary outcomes included blood loss, postoperative complications, ease of device use, ease of device set-up, vocal cord function, postoperative wound drainage, pain score, and adverse events.

Results

Of 110 patients assessed for eligibility, 100 were randomly allocated (UCSD: 49 patients; EBVS: 51 patients) and analyzed by intention-to-treat. There were no differences in specimen delivery time, total duration of surgery, wound drainage, and adverse events between the two groups. The UCSD group had a greater proportion of patients with higher postoperative pain scores in the first 72 h (8.1% vs. 2.0%, p = 0.043). Surgeons reported greater ease of use for the UCSD (49% vs. 27%; p = 0.005), while operating room staff favored the EBVS (60% vs. 33%, p = 0.005).

Conclusions

Energy devices are equally effective in reducing thyroidectomy operative times, with no differences in the duration of surgery, drainage, or adverse events. Use of the UCSD was associated with higher postoperative pain scores, but was favored by the surgeons, likely due to the ability to perform fine dissection with the device itself.

Notes

Acknowledgment

The authors would like to thank all patients who participated in this study, as well as the Clinical Trials and Epidemiology Unit, National Cancer Center Singapore, for supporting the study. This was an investigator-initiated trial funded in part by an NCCS Research Fund. NGI is supported by a National Medical Research Council Clinician–Scientist Award.

Supplementary material

10434_2019_7806_MOESM1_ESM.docx (51 kb)
Supplementary material 1 (DOCX 51 kb)

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Copyright information

© Society of Surgical Oncology 2019

Authors and Affiliations

  1. 1.Division of Surgical OncologyNational Cancer CentreSingaporeSingapore
  2. 2.Department of General SurgerySingapore General HospitalSingaporeSingapore
  3. 3.Division of Clinical Trials and Epidemiological SciencesNational Cancer Centre SingaporeSingaporeSingapore
  4. 4.Centre for Quantitative MedicineDuke–NUS Medical SchoolSingaporeSingapore
  5. 5.Population Health Sciences, Division of BiostatisticsUniversity of UtahSalt Lake CityUSA
  6. 6.SingHealth Duke–NUS Head and Neck CentreSingapore General HospitalSingaporeSingapore

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