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临床试验/NCT01189955
NCT01189955已完成不适用

The Use of Harmonic Scalpel Versus Knot Tying for Total Thyroidectomy: A Prospective Randomized Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
operative time

研究概览

简要总结

Consecutive patients treated for thyroid enlargement at our institution were evaluated for inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1 week, 1 month, and 6 months, Study variables included operative time, length of incision, operative bleeding, postoperative drainage, hospital stay and complication.

one hundred and thirty patients with thyroid enlargement were randomized and completed the study.

详细描述

Patients and method: Consecutive patients treated for thyroid enlargement at our institution were evaluated for inclusion. Participants were randomly allocated to receive total thyroidectomy using harmonic scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were after 1 week, 1 month, and 6 months, Study variables included operative time, length of incision, operative bleeding, postoperative drainage, hospital stay and complication.Preoperative preparation was performed for patients with thyrotoxicosis by antithyroid drug, and they were all euthyroid at the time of surgery. The routine pre-operative workup included measurement of thyroid-stimulating hormone and thyroid hormones (T3 and T4), as well as plasma levels of total calcium. In addition, a pre-operative laryngoscopy was performed.

A prophylactic antibiotic in the form of a third-generation cephalosporin was administered 2 hours before the operation. The operation was performed with the patient in the supine position under general anesthesia with endotracheal intubation. A Kocher incision, was made at the lower neck crease two finger above suprasternal notch.

In the HS group, using the new harmonic scalpel device Focus (Ethicon Endo Surgery, Cincinnati, OH, USA) was used for cutting and coagulation . For closure of and division of superior and inferior arteries and veins we set the instrument at a power 2 i.e. more coagulation. And when smaller vessels like capsule veins we set it to the level 5 i.e. more cutting The superior artery and vein was divided close to the gland to avoid damage to superior laryngeal nerve. And control of any bleeding from the bed using the active blade of harmonic. Finally we insert drain.

In the conventional group, mono- and bipolar coagulation, as well as ligatures, were allowed.

In both groups, the Intra-operative bleeding was estimated by weighing the gauzes before and after use. Furthermore, blood from suction (when used) was also recorded. Operation time was recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive patients treated for thyroid enlargement

排除标准

  • patients with one lobe pathology who need hemithyroidectomy, malignant thyroid previous neck operation, or a history of neck irradiation.

结局指标

主要结局

operative time

时间窗: 3 hours

次要结局

  • operative bleeding(30 days postoperative)
  • costs(30 days)
  • complications(30 days)

研究者

申办方类型
Other

研究点 (2)

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