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.
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2023
CompletedFirst Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 15, 2024
March 1, 2024
2.9 years
February 22, 2024
March 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (18)
The amount of drainage discharge 1
24 hours after the surgery
The amount of drainage discharge 2
48 hours after the surgery
The amount of drainage discharge 3
72 hours after the surgery
Concentration of triglycerides in the drainage discharge
72 hours after the surgery
Concentration of triglycerides in blood plasma
72 hours after the surgery
- +13 more secondary outcomes
Study Arms (2)
Lymphoblock
EXPERIMENTALPatients from this group received Lymphoblock.
Placebo
PLACEBO COMPARATORPatients from this group received placebo.
Interventions
Eligibility Criteria
You may qualify if:
- patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access
You may not qualify if:
- refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Petrovsky NRCS
Moscow, 119991, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduard Charchyan, MD
Petrovsky NRCS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2024
First Posted
February 29, 2024
Study Start
February 22, 2023
Primary Completion
February 1, 2026
Study Completion
May 1, 2026
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share