Fritz Dieter K, Matthews T Wayne, Chandarana Shamir P, Nakoneshny Steven C, Dort Joseph C
Department of Surgery, Section of Otolaryngology - Head & Neck Surgery, Cumming School of Medicine, University of Calgary, HRIC 2A02, 3280 Hospital Dr. NW, Calgary, AB, T2N 4Z6, Canada.
Ohlson Research Initiative, Arnie Charbonneau Cancer Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
J Otolaryngol Head Neck Surg. 2016 Nov 8;45(1):58. doi: 10.1186/s40463-016-0173-z.
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).
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.
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).
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.
ClinicalTrials.gov, NCT02017834 .
手术时间长和失血量大是导致术后发病的原因。因此，应采用可靠的方法来测试减少这些因素的策略。本研究的目的是评估使用超声刀对晚期口腔癌（OSCC）患者手术时间和失血量的影响。
2012年7月至2014年9月，36例需要进行原发肿瘤切除并单侧或双侧选择性颈清扫的晚期OSCC成年头颈部癌患者被随机分为对照组（传统手术）和试验组（超声刀手术）。年龄大于18岁且能提供知情同意书的患者符合入选条件。主要观察指标为：手术切除部分的术中失血量（毫升）和手术时间（分钟）。
试验组平均失血量为260毫升，而对照组为403毫升（p = 0.08）。试验组平均手术时间为140分钟，对照组为159分钟（p = 0.2）。
在这项随机对照试验中，对于晚期OSCC手术患者而言，使用超声刀对术中失血量或手术时间并无影响。
ClinicalTrials.gov，NCT02017834 。
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