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

NCT ID: NCT06286540

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Aorta Abdominalis; Aneurysm Aorta Thoracic; Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lymphoblock

Patients from this group received Lymphoblock.

Group Type EXPERIMENTAL

Lymphoblock

Intervention Type DEVICE

1 time per surgery with the exposition for 20 minutes.

Placebo

Patients from this group received placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

1 time per surgery with the exposition for 20 minutes.

Interventions

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Lymphoblock

1 time per surgery with the exposition for 20 minutes.

Intervention Type DEVICE

Placebo

1 time per surgery with the exposition for 20 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduard Charchyan, MD

Role: PRINCIPAL_INVESTIGATOR

Petrovsky NRCS

Locations

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Petrovsky NRCS

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Eduard Charchyan, MD

Role: CONTACT

+79262174114

Denis Breshenkov, Phd

Role: CONTACT

+79773439041

Facility Contacts

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Denis Breshenkov, Phd

Role: primary

+79773439041

Boris Tivelev

Role: backup

+79044244886

Other Identifiers

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26031993

Identifier Type: -

Identifier Source: org_study_id

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