NCT06286540

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Petrovsky National Research Centre of Surgery · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aorta Abdominalis; Aneurysm
• Aorta Thoracic; Aneurysm

Interventions

Type	Name	Description
DEVICE	Lymphoblock	1 time per surgery with the exposition for 20 minutes.
DEVICE	Placebo	1 time per surgery with the exposition for 20 minutes.

Timeline

• Start date: 2023-02-22
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2024-02-29
• Last updated: 2024-03-15

Locations

1 site across 1 country: Russia