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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
138
1 time per surgery with the exposition for 20 minutes.
1 time per surgery with the exposition for 20 minutes.
Petrovsky NRCS
Moscow, Russia
RECRUITINGNumber of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
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
Time frame: within 10 days of starting a regular diet after surgery
Number of Participants with Lymphocele
retroperitoneal liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
Time frame: 10 days after the surgery in patient who starting a regular diet after drainage removal
The amount of drainage discharge 1
volume of drainage discharge obtained in the first 24 hours after surgery, measured in milliliters (ml)
Time frame: 24 hours after the surgery
The amount of drainage discharge 2
volume of drainage discharge obtained in the first 48 hours after surgery, measured in milliliters (ml)
Time frame: 48 hours after the surgery
The amount of drainage discharge 3
volume of drainage discharge obtained in the first 72 hours after surgery, (ml)
Time frame: 72 hours after the surgery
Concentration of triglycerides in the drainage discharge
count of triglycerides in the drainage discharge, received from drainage tube, (mg/dL)
Time frame: 72 hours after the surgery
Concentration of triglycerides in blood plasma
count of triglycerides in the blood plasma, (mg/dL)
Time frame: 72 hours after the surgery
Concentration of cholesterol in the drainage discharge
count of cholesterol in the drainage discharge, received from drainage tube, (mg/dL)
Time frame: 72 hours after the surgery
Concentration of cholesterol in the blood plasma
count of cholesterol in the blood plasma, (mg/dL)
Time frame: 72 hours after the surgery
Concentration of protein in the drainage discharge
count of total protein in the drainage discharge, received from drainage tube, (g/dL)
Time frame: 72 hours after the surgery
Concentration of protein in the blood plasma
count of total protein in the blood plasma, (g/dL)
Time frame: 72 hours after the surgery
Concentration of albumin in the drainage discharge
count of albumin in the drainage discharge, received from drainage tube, (g/dL)
Time frame: 72 hours after the surgery
Concentration of albumin in the blood plasma
count of albumin in the blood plasma, (g/dL)
Time frame: 72 hours after the surgery
Concentration of lactate dehydrogenase in the drainage discharge
count of albumin in the drainage discharge, received from drainage tube (IU/L)
Time frame: 72 hours after the surgery
Concentration of lactate dehydrogenase in the blood plasma
count of lactate dehydrogenase in the blood plasma (IU/L)
Time frame: 72 hours after the surgery
Concentration of glucose in the drainage discharge
Content of glucose in the drainage discharge, received from drainage tube, (mg/dL)
Time frame: 72 hours after the surgery
Concentration of glucose in the blood plasma
Content of glucose in the blood plasma (mg/dL)
Time frame: 72 hours after the surgery
Number of Participants with Pleural effusion within 10 days
left pleural fluid accumulations (≥500 ml) after drainage removal drainage removal
Time frame: 10 days after the surgery in patient who starting a regular diet after drainage removal
Number of Participants with Lymphocele 3 months after the surgery
liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
Time frame: 3 months after the surgery
Number of Participants with Pleural effusion 3 months after the surgery
left pleural fluid accumulations (≥500 ml) after drainage removal
Time frame: 3 months after the surgery
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