Comparison of Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence rate of anastomotic complications
研究概览
简要总结
Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.
详细描述
Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Although the treatment of lung cancer is increasingly diverse, surgical resection is still the mainstay.
Pneumonectomy, as a surgical approach for central primary lung cancer, is very harmful to patients. Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. Both absorbable and non-absorbable suture are used for it. But there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.
The investigator sets incidence rate of anastomotic complications as the primary endpoint. According to the calculation, a total of 40 patients will be enrolled (each group has 20 patients).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old.
- •The tumor is located in the opening of bronchus, or the edge of the tumor is less than 2 cm away from the opening of the bronchi, while the distance between the edge of the tumor and the carina is more than 1.5 cm.
- •Patients with pathological diagnosis of non-small cell lung cancer.
- •No distant metastasis in preoperative clinical evaluation.
- •Adequate cardiac function, pulmonary function, liver function and renal function for anesthesia and bronchial sleeve resection.
- •American Society of Anesthesiologists (ASA) score: Grade I-III.
- •Patients who can coordinate the treatment and research and sign the informed consent.
排除标准
- •Patients with a significant medical condition which is thought unlikely to tolerate the surgery or unsuitable for this study after the evaluation of the investigator.
- •Patients with psychiatric disease who are expected lack of compliance with the protocol.
结局指标
主要结局
Incidence rate of anastomotic complications
时间窗: 12 months after surgery
such as anastomotic stenosis, anastomotic fistula and so on
次要结局
- Time of bronchial anastomosis(During surgery)
- Number of stitches(During surgery)
- 5-year survival rate(5 years after surgery)
研究者
jiaowenjie
Professor
The Affiliated Hospital of Qingdao University