Comparative Analysis Between A Bipolar Vessel Sealing and Cutting Device and the Tie and Suture Technique in Thyroidectomy: A Two Institution Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Operative time and surgical safety
研究概览
简要总结
Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments that use electrical powered diathermic energy to seal and transect tissue. These devices have shown high efficiency in a wide variety of open and laparoscopic general and gynecological surgical procedures.
The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic cutting devices in several studies. However, the efficacy of this instrument and in particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in thyroid surgery.
Our primary aim is to verify whether the EnSeal® performance is superior to the standard surgical technique for thyroidectomy in a randomized clinical trial on 2 different institutions.
详细描述
Background Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments that use electrical powered diathermic energy to seal and transect tissue. These devices have shown high efficiency in a wide variety of open and laparoscopic general and gynecological surgical procedures.
The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic cutting devices in several studies. However, the efficacy of this instrument and in particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in thyroid surgery.
Primary Aim To verify whether the EnSeal® performance is superior to the standard surgical technique for thyroidectomy in a randomized clinical trial on 2 different institutions
Patients and Methods A total of 160 patients will be included in the study. They will be divided into two groups of 80 subjects. Patients will undergo thyroidectomy in each of the two institutions: The National Institute of Medical Sciences and Nutrition in Mexico City and the Clinical Hospital in Sao Paolo Brazil. Surgical indication for thyroidectomy will comprise benign or malign diseases.
Design A balanced randomized clinical trial design for assessing superiority in 2 institutions. Patients with benign or malign thyroid disease will be balanced a priori within the 2 groups of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with thyroid diseases amenable of surgical resection
- •Benign or malign thyroid disease
- •Thyroid nodules ≤ 4cm
- •Patients with any gender or ethnical origin
- •Adults patients with 18-65 years-old
- •Postoperative follow-up of at least 2 weeks
- •Patients competent to understand and sign the informed consent
排除标准
- •Patients with clinical or biochemical hyperthyroidism
- •Preoperative indication for lateral lymph node dissection (radical modified)
- •Presence of gross tracheal or laryngeal invasion with thyroid cancer
- •Preoperative vocal cord paralysis or laryngeal disease
- •Patients with bleeding disorders or using anticoagulants
- •Patients with advanced or undifferentiated thyroid cancer
- •Patients with secondary hyperparathyroidism or parathyroid disease
- •Patients who do not want to accept to participate in the study
- •Elimination Criteria:
- •Intraoperative indication of lateral lymph node dissection (radical modified)
- •Intraoperative requirement of any tracheal or laryngeal resection
- •Malfunction of the devices (EnSeal or neuro-monitoring)
- •Any intraoperative conditions of the patient that require to stop or modified the surgery
- •Incomplete records, laboratories or clinical follow-up
- •Patients from vulnerable populations or non-competent to understand or sign the informed consent
结局指标
主要结局
Operative time and surgical safety
时间窗: One year
The primary outcomes will be operative time (minutes), blood loss (milliliters), transient and permanent hypoparathyroidism (calcium and PTH levels), loss of signal in laryngeal nerve monitoring, number of ligatures and pain intensity (EVA score).
次要结局
- Surgical complications(one year)