protocolSection identificationModule nctId: NCT06286540, orgStudyIdInfo id: 26031993, briefTitle: Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-22, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Petrovsky National Research Centre of Surgery, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Aorta Abdominalis; Aneurysm, conditions: Aorta Thoracic; Aneurysm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Lymphoblock, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea), primaryOutcomes measure: Number of Participants with Lymphocele, secondaryOutcomes measure: The amount of drainage discharge 1, secondaryOutcomes measure: The amount of drainage discharge 2, secondaryOutcomes measure: The amount of drainage discharge 3, secondaryOutcomes measure: Concentration of triglycerides in the drainage discharge, secondaryOutcomes measure: Concentration of triglycerides in blood plasma, secondaryOutcomes measure: Concentration of cholesterol in the drainage discharge, secondaryOutcomes measure: Concentration of cholesterol in the blood plasma, secondaryOutcomes measure: Concentration of protein in the drainage discharge, secondaryOutcomes measure: Concentration of protein in the blood plasma, secondaryOutcomes measure: Concentration of albumin in the drainage discharge, secondaryOutcomes measure: Concentration of albumin in the blood plasma, secondaryOutcomes measure: Concentration of lactate dehydrogenase in the drainage discharge, secondaryOutcomes measure: Concentration of lactate dehydrogenase in the blood plasma, secondaryOutcomes measure: Concentration of glucose in the drainage discharge, secondaryOutcomes measure: Concentration of glucose in the blood plasma, secondaryOutcomes measure: Number of Participants with Pleural effusion within 10 days, secondaryOutcomes measure: Number of Participants with Lymphocele 3 months after the surgery, secondaryOutcomes measure: Number of Participants with Pleural effusion 3 months after the surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Petrovsky NRCS, status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Denis Breshenkov, Phd, role: CONTACT, phone: +79773439041, email: denisbreshenkov@gmail.com, contacts name: Boris Tivelev, role: CONTACT, phone: +79044244886, email: boristivelev@gmail.com, contacts name: Omar Mutaev, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False