Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated With the Harmonic ACE® Scalpel and LigaSure Precise™ Instrument During Conventional Thyroidectomy: A Single-blind Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- operation time
研究概览
简要总结
The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.
Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)
详细描述
Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy
- •patients who are agree with the study enrollment
排除标准
- •an age under 20 or over 80 years
- •severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems)
- •a lack of consent to participate in the study
- •the inability to include a patient in clinical trials according to the regulations or laws in Korea
- •the inability to complete regular follow-up visits (e.g., immigration)
- •the use of modified radical neck dissection due to lateral neck node metastasis
- •prior thyroid surgery or cervical irradiation
- •active enrollment in another clinical trial
- •the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time)
- •the desire to undergo endoscopic or robot-assisted thyroidectomy
结局指标
主要结局
operation time
时间窗: from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery
from skin incision to skin closure
次要结局
- postoperative complications(at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery)
- postoperative drainage volume(estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery)
- admission time(documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery)
- Cost(documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery)
- Relapse-free survival (RFS)(from date of surgery until date of first documented recurrence or date of death from any cause, whichever came first, accessed up to 60 months)
- Overall Survival (OS)(from date of surgery until date of death from any cause, accessed up to 60 months)
研究者
Ja Seong Bae, MD, phD
Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine
Seoul St. Mary's Hospital