Evaluating a device to prevent lymph fluid leakage after aorta surgery
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.
This study is testing a new device called Lymphoblock to see if it can help prevent fluid leaks after surgery on the aorta for patients undergoing this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Petrovsky National Research Centre of Surgery Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06286540 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of the surgical device 'Lymphoblock' in preventing postoperative lymphorrhea in patients undergoing open surgical repair of the thoracoabdominal aorta. A total of 138 patients will be recruited and randomly assigned to receive either Lymphoblock or a placebo just before wound closure. The study will evaluate outcomes based on clinical and laboratory data, including blood tests and imaging studies to monitor for complications. The goal is to determine if Lymphoblock can effectively reduce the incidence of lymphatic fluid leakage following surgery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for open surgical repair of the thoracoabdominal aorta with retroperitoneal access.
Not a fit: Patients who refuse to participate in the study will not benefit from the intervention.
Why it matters
Potential benefit: If successful, this device could significantly reduce postoperative complications related to lymphorrhea, improving recovery outcomes for patients undergoing aorta repair.
How similar studies have performed: While similar approaches have been explored, this specific use of Lymphoblock for this indication is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access Exclusion Criteria: * refusal to participate in the study
Where this trial is running
Moscow
- Petrovsky NRCS — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Eduard Charchyan, MD — Petrovsky NRCS
- Study coordinator: Eduard Charchyan, MD
- Email: charchmed@yahoo.com
- Phone: +79262174114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.