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Randomized Controlled Trial
. 2016 Nov 8;45(1):58.
doi: 10.1186/s40463-016-0173-z.

Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial

Dieter K Fritz  1 , T Wayne Matthews  1   2 , Shamir P Chandarana  1   2 , Steven C Nakoneshny  2 , Joseph C Dort  3   4
Affiliations
Randomized Controlled Trial

Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial

Dieter K Fritz et al. J Otolaryngol Head Neck Surg. .

Abstract

Background: Long operating time and high blood loss contribute to post-surgical morbidity. Therefore, strategies to reduce these factors should to be tested using robust methods. The purpose of this study was to evaluate the impact of using the harmonic scalpel on operating time and blood loss in patients undergoing resection for advanced oral cancer (OSCC).

Methods: Thirty-six adult head and neck cancer patients with advanced OSCC requiring primary tumor resection with uni- or bi- lateral selective neck dissection from July 2012 to September 2014 were randomized to either the control group (traditional surgery) or the experimental group (harmonic surgery). Patients older than 18 years who were able to provide informed consent were eligible. Primary outcomes of interest were: intraoperative blood loss (mL) and operative time (minutes) for the ablative part of the surgery.

Results: Mean blood loss in the experimental group was 260 mL versus 403 mL in the control group (p = 0.08). Mean operative time was 140 min in the experimental group and 159 min in the control group (p = 0.2).

Conclusions: In this randomized controlled trial, use of the harmonic scalpel did not effect intraoperative blood loss or OR time in patients undergoing surgery for advanced OSCC.

Trial registration: ClinicalTrials.gov, NCT02017834 .

Keywords: Harmonic scalpel; Head and neck squamous cell carcinoma; Health technology assessment; Oral cancer; Randomized clinical trial.

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Figures

Fig. 1
Fig. 1
Study flow diagram. HN, head and neck; OR, operating room
Fig. 2
Fig. 2
Primary outcomes
See this image and copyright information in PMC

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