Abstract
PurposeNew energy-based sutureless vessel ligation devices, such as the Thunderbeat (Olympus Medical Systems Corp., Tokyo, Japan), could reduce operative time and limit blood loss in head and neck surgery; however, efficacy and safety in major head and neck surgery have not been investigated in a prospective, randomized study.MethodsThis prospective, double-arm, randomized controlled trial consisted of two parts: total laryngectomy (TL) and neck dissection (ND). Thirty patients planned for TL were randomized in two groups. For the ND part, forty-two operative sides were likewise randomized. In both parts, Thunderbeat was used in addition to the standard instrumentation in the intervention groups, while only standard instrumentation was used in the control groups. Primary outcome values were blood loss, operative time and complication rate.ResultsFor the TL part there was no difference in mean blood loss (p = 0.062), operative time (p = 0.512) and complications (p = 0.662) between both hemostatic techniques. For the neck dissection part, there was a reduction in blood loss (mean 210 mL versus 431 mL, p = 0.046) and in operative time (median 101 (IQR 85–130) minutes versus 150 (IQR 130–199) minutes, p = 0.014) when Thunderbeat was used. There was no difference in complication rate between both hemostatic systems (p = 0.261).ConclusionThe Thunderbeat hemostatic device significantly reduces operative blood loss and operative time for neck dissections, without increase in complications. In TL, blood loss using Thunderbeat was comparable with the standard technique, but the operative time tended to be shorter.Trial registrationUMCG Research Register, Reg. no. 201700041, date of registration: 18/1/2017
Highlights
A total laryngectomy (TL) with additional neck dissection (ND) is considered as major head and neck surgery
The study was checked by the Institutional Review Board of the University Medical Center Groningen (UMCG) and judged as according to the Dutch Medical Research Law, there is no need for Institutional Review Board approval; a waiver was released
This study has indicated that the TB is at least as safe as the standard electrocautery devices (SED) during TL and ND, as the statistically insignificant difference was found in favor of the TB group
Summary
A total laryngectomy (TL) with additional neck dissection (ND) is considered as major head and neck surgery. During head and neck surgery, precise hemostasis ensures a Surgery, Radboud University Medical Center, Nijmegen, The Netherlands 4 Department of Otorhinolaryngology, Head and Neck Surgery, Haaglanden Medical Center, The Hague, The Netherlands clear view on the surgical field. Minimalizing blood loss and operative time are beneficial both for the patient and cost-effectiveness [1]. Traditional instruments for dissecting and controlling hemostasis during head and neck surgery are bipolar forceps and monopolar scalpel, with the additional ligation or clipping for larger vessels. Some operative time is lost due to switching between operative instruments. Reduced operative time can be expected if the same device is used for both dissection and hemostasis
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