Shen-Han Lee1,2, Thien Khanh Nguyen1,2, Whee-Sze Ong3, Benjamin Haaland4,5, Gerald Ci-An Tay2,6, Ngian Chye Tan1,6, Hiang Khoon Tan1,2,6, Jeremy Chung Fai Ng2,6, N Gopalakrishna Iyer7,8. 1. Division of Surgical Oncology, National Cancer Centre, Singapore, Singapore. 2. Department of General Surgery, Singapore General Hospital, Singapore, Singapore. 3. Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, Singapore, Singapore. 4. Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore. 5. Population Health Sciences, Division of Biostatistics, University of Utah, Salt Lake City, UT, USA. 6. SingHealth Duke-NUS Head and Neck Centre, Singapore General Hospital, Singapore, Singapore. 7. Division of Surgical Oncology, National Cancer Centre, Singapore, Singapore. gopaliyer@yahoo.com. 8. SingHealth Duke-NUS Head and Neck Centre, Singapore General Hospital, Singapore, Singapore. gopaliyer@yahoo.com.
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.
RCT Entities:
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.
Authors: Thomas von Ahnen; Josefine Schardey; Martin von Ahnen; Peter Busch; Emily Schardey; Mohsen Ali Ezzy; Stefan Schopf; Ulrich Wirth Journal: JAMA Otolaryngol Head Neck Surg Date: 2022-07-01 Impact factor: 8.961
Authors: Gian Luigi Canu; Fabio Medas; Federico Cappellacci; Francesco Casti; Raffaela Bura; Enrico Erdas; Pietro Giorgio Calò Journal: J Clin Med Date: 2022-05-29 Impact factor: 4.964