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临床试验/NCT07386028
NCT07386028招募中不适用

Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology

Tomsk Cardiology Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Early mortality

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent.
  • Ascending aorta greater than 5 cm without involving the aortic arch

排除标准

  • Acute aortic dissection or urgent/emergent cases.
  • Redo aortic surgery.
  • Aortic arch surgery.
  • Concomitant CABG or left ventricle restoration

研究组 & 干预措施

Full Sternotomy

Active Comparator

100 patients who will undergo hemiarch repair via full sternotomy

干预措施: Full sternotomy (Procedure)

Mini J-Sternotomy

Active Comparator

100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy

干预措施: J-shaped mini-sternotomy (Procedure)

结局指标

主要结局

Early mortality

时间窗: during follow-up time - 60 months

The difference in the incidence of early mortality between groups (p-value).

次要结局

  • Delirium (percent)(Perioperative/Periprocedural)
  • Transient ischemic attack (percent)(Perioperative/Periprocedural)
  • Stroke (percent)(during follow-up time - 60 months)
  • Respiratory failure (percent)(Perioperative/Periprocedural)
  • New arrythmia (percent)(during follow-up time - 60 months)
  • Pericardial effusion (percent)(Perioperative/Periprocedural)
  • Heart failure (percent)(during follow-up time - 60 months)
  • Myocardial infarction (percent)(during follow-up time - 60 months)
  • Systemic embolism (percent)(during follow-up time - 60 months)
  • Acute kidney injury requiring renal replacement therapy (percent)(during follow-up time - 60 months)
  • Re-exploration rate (percent)(during follow-up time - 60 months)

研究者

发起方
Tomsk Cardiology Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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