Clinical trial NCT06286540: Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aorta Abdominalis; Aneurysm
Aorta Thoracic; Aneurysm
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
timeFrame: within 10 days of starting a regular diet after surgery
measure: Number of Participants with Lymphocele
timeFrame: 10 days after the surgery in patient who starting a regular diet after drainage removal
Secondary outcomes:
measure: The amount of drainage discharge 1
timeFrame: 24 hours after the surgery
measure: The amount of drainage discharge 2
timeFrame: 48 hours after the surgery
measure: The amount of drainage discharge 3
timeFrame: 72 hours after the surgery
measure: Concentration of triglycerides in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of triglycerides in blood plasma
timeFrame: 72 hours after the surgery
measure: Concentration of cholesterol in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of cholesterol in the blood plasma
timeFrame: 72 hours after the surgery
measure: Concentration of protein in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of protein in the blood plasma
timeFrame: 72 hours after the surgery
measure: Concentration of albumin in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of albumin in the blood plasma
timeFrame: 72 hours after the surgery
measure: Concentration of lactate dehydrogenase in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of lactate dehydrogenase in the blood plasma
timeFrame: 72 hours after the surgery
measure: Concentration of glucose in the drainage discharge
timeFrame: 72 hours after the surgery
measure: Concentration of glucose in the blood plasma
timeFrame: 72 hours after the surgery
measure: Number of Participants with Pleural effusion within 10 days
timeFrame: 10 days after the surgery in patient who starting a regular diet after drainage removal
measure: Number of Participants with Lymphocele 3 months after the surgery
timeFrame: 3 months after the surgery
measure: Number of Participants with Pleural effusion 3 months after the surgery
timeFrame: 3 months after the surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky NRCS
Study officials:
affiliation: Petrovsky NRCS
name: Eduard Charchyan, MD
role: PRINCIPAL_INVESTIGATOR
References: