Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.

Petrovsky National Research Centre of Surgery

Status: Enrolling

Conditions: Aorta Abdominalis; Aneurysm; Aorta Thoracic; Aneurysm

Treatments: Device: Placebo; Device: Lymphoblock

Study type: Interventional

Funder types: Other

Identifiers

NCT06286540

26031993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access

Exclusion criteria

• refusal to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

Lymphoblock

Experimental group

Description:

Patients from this group received Lymphoblock.

Treatment:

Device: Lymphoblock

Placebo

Placebo Comparator group

Description:

Patients from this group received placebo.

Treatment:

Device: Placebo