Aorta Abdominalis; Aneurysm, Aorta Thoracic; Aneurysm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELymphoblock
1 time per surgery with the exposition for 20 minutes.
DEVICEPlacebo
1 time per surgery with the exposition for 20 minutes.
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access
Exclusion criteria
* refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea) | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of drainage discharge 3 | 72 hours after the surgery | volume of drainage discharge obtained in the first 72 hours after surgery, (ml) |
| Concentration of triglycerides in the drainage discharge | 72 hours after the surgery | count of triglycerides in the drainage discharge, received from drainage tube, (mg/dL) |
| Concentration of triglycerides in blood plasma | 72 hours after the surgery | count of triglycerides in the blood plasma, (mg/dL) |
| Concentration of cholesterol in the drainage discharge | 72 hours after the surgery | count of cholesterol in the drainage discharge, received from drainage tube, (mg/dL) |
| Concentration of cholesterol in the blood plasma | 72 hours after the surgery | count of cholesterol in the blood plasma, (mg/dL) |
| Concentration of protein in the drainage discharge | 72 hours after the surgery | count of total protein in the drainage discharge, received from drainage tube, (g/dL) |
| Concentration of protein in the blood plasma | 72 hours after the surgery | count of total protein in the blood plasma, (g/dL) |
| Concentration of albumin in the drainage discharge | 72 hours after the surgery | count of albumin in the drainage discharge, received from drainage tube, (g/dL) |
| The amount of drainage discharge 1 | 24 hours after the surgery | volume of drainage discharge obtained in the first 24 hours after surgery, measured in milliliters (ml) |
| Concentration of lactate dehydrogenase in the drainage discharge | 72 hours after the surgery | count of albumin in the drainage discharge, received from drainage tube (IU/L) |
| Concentration of lactate dehydrogenase in the blood plasma | 72 hours after the surgery | count of lactate dehydrogenase in the blood plasma (IU/L) |
| Concentration of glucose in the drainage discharge | 72 hours after the surgery | Content of glucose in the drainage discharge, received from drainage tube, (mg/dL) |
| Concentration of glucose in the blood plasma | 72 hours after the surgery | Content of glucose in the blood plasma (mg/dL) |
| Number of Participants with Pleural effusion within 10 days | 10 days after the surgery in patient who starting a regular diet after drainage removal | left pleural fluid accumulations (≥500 ml) after drainage removal drainage removal |
| Number of Participants with Lymphocele 3 months after the surgery | 3 months after the surgery | liquid formation ≥5 cm in diameter according to ultrasound after drainage removal |
| Number of Participants with Pleural effusion 3 months after the surgery | 3 months after the surgery | left pleural fluid accumulations (≥500 ml) after drainage removal |
| Concentration of albumin in the blood plasma | 72 hours after the surgery | count of albumin in the blood plasma, (g/dL) |
| The amount of drainage discharge 2 | 48 hours after the surgery | volume of drainage discharge obtained in the first 48 hours after surgery, measured in milliliters (ml) |
Countries
Russia
Contacts
Primary ContactEduard Charchyan, MD
Backup ContactDenis Breshenkov, Phd
Outcome results
None listed