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

Not Applicable

Recruiting

• Conditions: Aorta Abdominalis; Aneurysm; Aorta Thoracic; Aneurysm
• Interventions: Device: Placebo; Device: Lymphoblock

• Registration Number: NCT06286540
• Lead Sponsor: Petrovsky National Research Centre of Surgery

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.

Study Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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

Exclusion Criteria

• refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients from this group received placebo.
Lymphoblock	Lymphoblock	Patients from this group received Lymphoblock.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
The amount of drainage discharge 3	72 hours after the surgery	volume of drainage discharge obtained in the first 72 hours after surgery, (ml)
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)
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 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 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 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 albumin in the drainage discharge	72 hours after the surgery	count of albumin in the drainage discharge, received from drainage tube, (g/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
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 triglycerides in blood plasma	72 hours after the surgery	count of triglycerides in the blood plasma, (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 albumin in the blood plasma	72 hours after the surgery	count of albumin in the blood plasma, (g/dL)
Concentration of lactate dehydrogenase in the blood plasma	72 hours after the surgery	count of lactate dehydrogenase in the blood plasma (IU/L)
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
Concentration of protein in the blood plasma	72 hours after the surgery	count of total protein in the blood plasma, (g/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 3 months after the surgery	3 months after the surgery	left pleural fluid accumulations (≥500 ml) after drainage removal

Trial Locations

Locations (1)

Petrovsky NRCS; 🇷🇺 Moscow, Russian Federation