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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphoblock | Experimental | Patients from this group received Lymphoblock. |
|
| Placebo | Placebo Comparator | Patients from this group received placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphoblock | Device | 1 time per surgery with the exposition for 20 minutes. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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 | 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 | 10 days after the surgery in patient who starting a regular diet after drainage removal |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of drainage discharge 1 | volume of drainage discharge obtained in the first 24 hours after surgery, measured in milliliters (ml) | 24 hours after the surgery |
| The amount of drainage discharge 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduard Charchyan, MD | Contact | +79262174114 | charchmed@yahoo.com | |
| Denis Breshenkov, Phd | Contact | +79773439041 | denisbreshenkov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eduard Charchyan, MD | Petrovsky NRCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky NRCS | Recruiting | Moscow | 119991 | Russia |
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| Placebo |
| Device |
1 time per surgery with the exposition for 20 minutes. |
|
volume of drainage discharge obtained in the first 48 hours after surgery, measured in milliliters (ml)
| 48 hours after the surgery |
| The amount of drainage discharge 3 | volume of drainage discharge obtained in the first 72 hours after surgery, (ml) | 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) | 72 hours after the surgery |
| Concentration of triglycerides in blood plasma | count of triglycerides in the blood plasma, (mg/dL) | 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) | 72 hours after the surgery |
| Concentration of cholesterol in the blood plasma | count of cholesterol in the blood plasma, (mg/dL) | 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) | 72 hours after the surgery |
| Concentration of protein in the blood plasma | count of total protein in the blood plasma, (g/dL) | 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) | 72 hours after the surgery |
| Concentration of albumin in the blood plasma | count of albumin in the blood plasma, (g/dL) | 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) | 72 hours after the surgery |
| Concentration of lactate dehydrogenase in the blood plasma | count of lactate dehydrogenase in the blood plasma (IU/L) | 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) | 72 hours after the surgery |
| Concentration of glucose in the blood plasma | Content of glucose in the blood plasma (mg/dL) | 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 | 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 | 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 | 3 months after the surgery |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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