Efficacy and Safety of Lymphoblock in the Prevention of Postoperative Lymphorrhea After Surgical Treatment of the Thoracoabdominal Aorta: a Single-center, Randomized, Placebo-controlled, Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
研究概览
简要总结
Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.
详细描述
The study design will include patients with open surgical repair of the thoracoabdominal aorta who underwent thoracophrenolumbotomy with retroperitoneal exposure of the aorta. It is assumed the lymphoblock to reduce the incidence of postoperative lympho-/chylorrhea. Patients will be divided based on randomization into groups that will receive a lymphoblock or a placebo. It is planned to recruit 138 patients, 69 patients in each group. The drug will be used right before wound closure. The solution will be applied to the surface of the wound with further exposure and draining. Blood test and drainage discharge parameters (from the left pleural cavity and retroperitoneum) will be examined in postoperative period. The thoracic and abdominal CT and ultrasound will be performed to exclude presence of effusion and/or lymphocele.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access
排除标准
- •refusal to participate in the study
研究组 & 干预措施
Lymphoblock
Patients from this group received Lymphoblock.
干预措施: Lymphoblock (Device)
Placebo
Patients from this group received placebo.
干预措施: Placebo (Device)
结局指标
主要结局
Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
时间窗: within 10 days of starting a regular diet after surgery
This outcome will be determined by assessing the milky of the drainage discharge, and comparing the content of triglycerides, glucose, cholesterol and lactate dehydrogenase (LDH) in the drainage discharge with those in the blood plasma
Number of Participants with Lymphocele
时间窗: 10 days after the surgery in patient who starting a regular diet after drainage removal
retroperitoneal liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
次要结局
- The amount of drainage discharge 2(48 hours after the surgery)
- Concentration of protein in the drainage discharge(72 hours after the surgery)
- The amount of drainage discharge 3(72 hours after the surgery)
- Concentration of cholesterol in the drainage discharge(72 hours after the surgery)
- Concentration of lactate dehydrogenase in the drainage discharge(72 hours after the surgery)
- Number of Participants with Pleural effusion 3 months after the surgery(3 months after the surgery)
- Concentration of albumin in the drainage discharge(72 hours after the surgery)
- Concentration of glucose in the drainage discharge(72 hours after the surgery)
- Number of Participants with Pleural effusion within 10 days(10 days after the surgery in patient who starting a regular diet after drainage removal)
- The amount of drainage discharge 1(24 hours after the surgery)
- Concentration of triglycerides in blood plasma(72 hours after the surgery)
- Concentration of cholesterol in the blood plasma(72 hours after the surgery)
- Concentration of albumin in the blood plasma(72 hours after the surgery)
- Concentration of lactate dehydrogenase in the blood plasma(72 hours after the surgery)
- Number of Participants with Lymphocele 3 months after the surgery(3 months after the surgery)
- Concentration of triglycerides in the drainage discharge(72 hours after the surgery)
- Concentration of protein in the blood plasma(72 hours after the surgery)
- Concentration of glucose in the blood plasma(72 hours after the surgery)