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

Last updated: March 12, 2024
Sponsor: Petrovsky National Research Centre of Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Placebo

Lymphoblock

Clinical Study ID

NCT06286540
26031993
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aorticaccess

Exclusion

Exclusion Criteria:

  • refusal to participate in the study

Study Design

Total Participants: 138
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
February 22, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Petrovsky NRCS

    Moscow, 119991
    Russian Federation

    Active - Recruiting

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