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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Aorta Abdominalis; Aneurysm; Aorta Thoracic; Aneurysm
• Intervention / Treatment: Device: Lymphoblock; Device: Placebo

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduard Charchyan, MD; Phone Number: +79262174114; Email: charchmed@yahoo.com
• Study Contact Backup: Name: Denis Breshenkov, Phd; Phone Number: +79773439041; Email: denisbreshenkov@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Petrovsky NRCS
    • Contact: Denis Breshenkov, Phd; Phone Number: +79773439041; Email: denisbreshenkov@gmail.com
    • Contact: Boris Tivelev; Phone Number: +79044244886; Email: boristivelev@gmail.com
    • Sub-Investigator: Omar Mutaev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lymphoblock; Patients from this group received Lymphoblock.	Device: Lymphoblock; 1 time per surgery with the exposition for 20 minutes.
Placebo Comparator: Placebo; Patients from this group received placebo.	Device: Placebo; 1 time per surgery with the exposition for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Eduard Charchyan, MD, Petrovsky NRCS

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm; Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: 26031993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No