Harmonic Scalpel versus Conventional Haemostasis in Neck Dissection: A Prospective Randomized Study

Abstract

Purpose. The aim of this prospective randomized trial was to compare operative factors, postoperative outcomes, and surgical complications of neck dissection (ND) when using the harmonic scalpel (HS) versus conventional haemostasis (CH) (classic technique of tying and knots, resorbable ligature, and bipolar diathermy). Materials and methods. Sixty-one patients who underwent ND with primary head and neck cancer (HNSCC) resection were enrolled in this study and were randomized into two homogeneous groups: CH (conventional haemostasis with classic technique of tying and knots, resorbable ligature, and bipolar diathermy) and HS (haemostasis with harmonic scalpel). Outcomes of the study included operative time, intraoperative blood loss, drainage volume, postoperative pain, hospital stay, and incidence of intraoperative and postoperative complications. Results. The use of the HS reduced significantly the operating time, the intraoperative blood loss, the postoperative pain, and the volume of drainage. No significant difference was observed in mean hospital stay and perioperative, and postoperative complications. Conclusion. The HS is a reliable and safe tool for reducing intraoperative blood loss, operative time, volume of drainage and postoperative pain in patients undergoing ND for HNSCC. Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio.

The Harmonic Scalpel versus Conventional Hemostasis for Neck Dissection: A Meta-Analysis of the Randomized Controlled Trials

“…The studies by Dean [ 11 ] and Salami et al [ 16 ] were identified as being of a lower design quality because neither comprised blinded participants or an outcome assessment, and the use and reporting of random sequence generation and allocation concealment may have been inadequate. In addition, the quality of the studies by Ferri [ 8 ] and Walen et al [ 14 ] was moderate ( Fig 2 ). Overall, the agreement between the two assessors about the quality of the seven studies was moderate or high, although there was still some controversy.…”

“…When the six studies were quantitatively combined, the mean difference in the total drainage fluid volume for the neck dissection was 64.9 milliliters less using the harmonic scalpel compared with conventional hemostasis [mean difference: -64.86; 95% CI = (-110.40, -19.32); P = 0.005] ( Fig 7 ). However, the statistical heterogeneity was great and was driven by three studies (Ferri [ 8 ], Dean [ 11 ] and Miccoli et al [ 15 ]). When these three studies were excluded, the heterogeneity and the effect measure were not significant [I 2 = 0%; mean difference: 3.09; 95% CI = (-7.99, 14.17); P = 0.58] ( Fig 8 ).…”

“…New surgical devices and technologies that focus on reducing operative time, blood loss, and other complications have been investigated and the results have been favorable [ 8 ]. The harmonic scalpel (HS) was introduced in the early 1990s and has 4 functions during the surgery: cutting of the tissues, cavitation, coaptation of the tissues and coagulation.…”

Compilation About Adverse Events Recorded in FDA/ USA and ANVISA/Brazil Databases Through Models Available in the Literature Concerning Analysis and Prioritization of Actions for Medical Devices

“…28 Studies claim the benefits of this equipment, including allowing faster and safe surgical procedures. 29 However, the alerts show that no device is exempt from technical and human failures; for example, there might be improper cutting.…”

Risk factors for postoperative hemorrhage in patients with oral squamous cell carcinoma: A retrospective study

“…Postoperative hemorrhage includes hematoma formation, jugular vein rupture, and carotid blowout. Hematomas are reported to have an incidence of 2% in oral cancer surgery and account for most of the hemorrhage cases . Jugular vein ruptures may result from infections or iatrogenic vessel wall injuries .…”