Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Full sternotomy, J-shaped mini-sternotomy.
- Кому может быть актуально
- Состояния в реестре: Ascending Aortic Aneurysm. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
Обзор
This study investigates outcomes after hemiarch repair in patients with chronic ascending aortic disease. The patients will be divided into two groups according to surgical approach: 100 patients will undergo hemiarch repair via full sternotomy (FS group) and 100 patients will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Early and late outcomes will be recorded.
Подробное описание
1. Relevance of the study Hemiarch repair is an effective treatment for patients with ascending aortic aneurysm (AAR). All aortic procedures are routinely performed from full mean sternotomy but nowadays this standard could be performed via minimally invasive approach as well. There are some data that mini-J sternotomy is associated with less blood loss and blood products transfusion, improved lung function and eliminates wound complications risks. The aim of this study was to assess the morbidity and mortality after hemiarch repair via full or J-shaped mini-sternotomy. 2. Patients and methods Patients who will undergo hemiarch repair procedure via full sternotomy (FS group) will be compared with patients who will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Baseline characteristics including preoperative clinical status, details on surgery, and postoperative outcomes will be compared between these groups. Follow-up data will be recorded.
Imaging All aortic measurements will be assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta will be performed within 2 weeks after surgery. Analysis will be performed using 64-slice scanner Discovery NM-CT 570c (GE Healthcare, Milwaukee, WI, USA) with spatial resolution of the angiographic phase ranging from 0.6 to 1.25 mm. All measurements will be taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) will be measured from the outer contours of the aortic wall. All images will be independently assessed by two experienced cardiologists.
Surgical technique The hemiarch repair is performed via a full sternotomy or J-shaped mini-sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion through the innominate artery with side graft. The distal aortic anastomosis is performed using an open anastomosis fashion and involved resection of the inferior portion of the aortic arch from the base of the innominate artery to the projection of the origin of the left subclavian artery. Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) is used for cerebral monitoring during the operation. When the target temperature is achieved, lower body circulatory arrest with antegrade cerebral perfusion is initiated. The distal aortic anastomosis is performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic reconstruction including Bentall procedure, David procedure, proximal aortic anastomosis, etc. are performed during the rewarming period. The patient is weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation are the same for all patients.
Follow-up Follow-up will be performed according to the institutional database supplemented by individual patient records. Data will be obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans will be performed upon discharge, at 12 months from the last procedure and at 60 months thereafter.
Вмешательства
- Процедура Full sternotomy
hemiarch repair via full sternotomy - Процедура J-shaped mini-sternotomy
hemiarch repair via J-shaped mini-sternotomy
Первичные конечные точки
- Early mortality [Срок оценки: during follow-up time - 60 months]
Вторичные конечные точки (11)
- Delirium (percent) [Срок оценки: Perioperative/Periprocedural]
- Transient ischemic attack (percent) [Срок оценки: Perioperative/Periprocedural]
- Stroke (percent) [Срок оценки: during follow-up time - 60 months]
- Respiratory failure (percent) [Срок оценки: Perioperative/Periprocedural]
- New arrythmia (percent) [Срок оценки: during follow-up time - 60 months]
- Pericardial effusion (percent) [Срок оценки: Perioperative/Periprocedural]
- Heart failure (percent) [Срок оценки: during follow-up time - 60 months]
- Myocardial infarction (percent) [Срок оценки: during follow-up time - 60 months]
- Systemic embolism (percent) [Срок оценки: during follow-up time - 60 months]
- Acute kidney injury requiring renal replacement therapy (percent) [Срок оценки: during follow-up time - 60 months]
- Re-exploration rate (percent) [Срок оценки: during follow-up time - 60 months]
Критерии участия
Критерии включения
- Signed informed consent.
- Ascending aorta greater than 5 cm without involving the aortic arch
Критерии исключения
- Acute aortic dissection or urgent/emergent cases.
- Redo aortic surgery.
- Aortic arch surgery.
- Concomitant CABG or left ventricle restoration
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Россия · 1 центр
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of — Tomsk
Идентификаторы
NCT: NCT07386028 · 260