Effect of Neck Flexion on Post-operative Esophagogastric Anastomotic Leakage After Minimally Invasive Esophagectomy: a Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of post-operative cervical esophagogastric anastomotic leakage
研究概览
简要总结
Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.
详细描述
After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
- •Surgical resectable (T1-4a, N0-3, M0).
- •Age≥18 and ≤75 years.
- •European Clinical Oncology Group (ECOG) performance status 0,1 or
- •Written informed consent obtain.
排除标准
- •Carcinoma of the cervical esophagus.
- •Carcinoma of the gastro-esophageal junction (GEJ).
- •Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -Dysfunction of cardiorespiratory system or other surgical contraindications.
研究组 & 干预措施
neck flexion group
Patients who fixed in neck flexion position after MIE
干预措施: neck flexion (Procedure)
control group
Patients without posture intervention after MIE
结局指标
主要结局
Incidence of post-operative cervical esophagogastric anastomotic leakage
时间窗: From the day of operation to hospital discharge (an expected average of 2 weeks)
The post-operative cervical esophagogastric anastomotic leakage is defined as a radiological defect at the anastomotic site, or leakage of swallowed fluid (saliva, gastric juice or food residue) out of the drain site or cervical wound.
次要结局
未报告次要终点
研究者
Kun Li, MD
Kun Li
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University