Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
研究概览
简要总结
Surgical treatment of lung cancer consists of two elements: anatomical lung resection (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node dissection (MLND). Since over last 15 years the growing rate of resection is performed by minimal invasive approach - video-assisted thoracoscopic surgery (VATS). The study is focused on the clinical and technical aspects of MLND during VATS lobectomy. The extension of lymph nodes resection is strictly specified. The main benefit of MLND for the patient is precise histopathological staging, which allows choosing the best therapeutic option of adjuvant therapy. MLND is related with potential minor and major complications (bleeding, increased volume of chest tube drainage, prolonged chest tube duration and hospital stay, chylothorax, left recurrent laryngeal nerve injury, injury of the bronchus, injury of the esophagus). The majority of complications are caused by thermal injury resulting from the use of heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection. In addition, thermal energy generation in case of monopolar electrocautery may lead to systemic inflammatory response and increased surgical injury. High-energy sealing devices like LigaSure™ allow for dissection, coagulation and cutting with the single instrument. Compared to mechanical ligation techniques (vessel loops, clips) or monopolar electrocautery, LigaSure™ technology has been shown to reduce: intraoperative blood loss (in colorectal, gynecologic and urologic surgery), surgery time (in colorectal, gynecologic and urologic surgery), length of hospital stay (in gynecologic and urologic surgery). Investigators hypothesize that application of LigaSure™ in VATS anatomical resection may lead to diminished complications rate, lower systemic inflammatory response and shorter length of stay compared to monopolar electrocautery.
详细描述
Summary
Surgical treatment of lung cancer consists of two elements: anatomical lung resection (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node sampling (MLNS) or mediastinal lymph node dissection (MLND). Since over last 15 years the growing rate of resection is performed by minimal invasive approach - video-assisted thoracoscopic surgery (VATS). This technique is used in at least 60% of patients with lung cancer operated on in the leading centers. The study project is focused on the clinical and technical aspects of MLNS/MLND during VATS lobectomy. Lymphadenectomy has to be performed obligatory in case of lung cancer resection. The extension of lymph nodes resection or sampling is strictly specified and should be the same independently from the surgical approach (thoracotomy or VATS). The main benefit of MLNS/MLND for the patient is precise histopathological staging, which allows choosing the best therapeutic option of adjuvant therapy. It was proved that MLND is superior to MLNS in its accuracy however the improvement of local control of the disease is not proved.
Mediastinal lymphadenectomy is related with potential minor and major complications. The risk of complications is low but in case of their occurrence hospital stay is usually significantly prolonged, quality of life decreases and additional surgery may be needed. In very small group of patients complications may lead to severe disability or death.
The most frequent complications related with MLND are:
- Bleeding, sometimes requiring redo surgery;
- Increased volume of chest tube drainage with prolonged chest tube duration and hospital stay;
- Chylothorax;
- Left recurrent laryngeal nerve injury;
- Injury of the bronchus (especially of posterior part of right main bronchus during dissection of subcarinal lymph nodes);
- Injury of the esophagus (dissection of subcarinal and paraesophageal lymph nodes).
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery performed by Video-Assisted Thoracic Surgery technique (VATS).
- •Mediastinal Lymph Node Dissection performed due to the European Society of Thoracic Surgeons
- •Patients must be informed and must sign and give written informed consent.
排除标准
- •Preoperative radiotherapy.
- •Preoperative chemotherapy.
- •Mediastinoscopy or other surgical procedures of mediastinum prior to the present surgery.
- •Chest surgery on the side to be operated.
- •Conversion from VATS to thoracotomy
研究组 & 干预措施
LigaSure
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
干预措施: LigaSure™ (Device)
Monopolar electrocautery
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
干预措施: Monopolar electrocautery (Device)
结局指标
主要结局
Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
时间窗: Total postoperative chest drainage volume
Measurement of the postoperative volume of fluid drained in milliliters, measured up to chest drain removal, average 3 days.
次要结局
- Acute Phase Proteins Levels.(72 hours after surgery)
- Local Temperature.(During mediastinal lymph nodes dissection (during surgery))