跳至主要内容
临床试验/NCT04726488
NCT04726488Unknown不适用

Periareolar Approach in Minimally Invasive Cardiac Surgery; New Trend.

Assiut University0 个研究点目标入组 102 人开始时间: 2021年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
主要终点
Duration of surgery

研究概览

简要总结

Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).

  • Objective1: Test the hypothesis that, the periareolar approach is more feasible and safer than the inframammary approach.
  • Objective2: Identify risk factors that are predictive of the need for periareolar approach.
  • Objective3: Assess outcomes and postoperative results of both periareolar and inframammary approach.

详细描述

The first successful cardiac operation was performed in 1896, in Germany by Rehn (1), followed by the first successful cardiac valve operation in 1912 by Tuffier (2) and the first successful mitral valve operation in 1923 (3).

In 1956, Lillehei repaired multiple valvular lesions through a right thoracotomy using cardiopulmonary bypass (4).

In the 1990s, the success of laparoscopic operations in general surgery renewed an interest in minimally invasive approaches for cardiac surgery. Navia and Cosgrove (5) and Cohn et al. (6) performed the first minimally invasive valve operations via the right parasternal and transsternal approaches. Remarkably, excellent exposure was achieved through smaller incisions, thereby making complex valve repair possible and safe.

In 1996, Carpentier et al. (7) performed the first video-assisted mitral valve repair through a minithoracotomy using ventricular fibrillation. With more experience, video-assisted, 2-dimensional endoscopes and robotics were introduced by Carpentier (7) and Chitwood (8,9).

In 2009 Poffo et al (10,11) describe a new technique of minimally invasive cardiac surgery. He and his colleagues adopting periareolar access for mitral valve surgery since 2006 and published this technique in 2009.

研究设计

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

盲法说明

All investigators will be blinded (i.e., closed envelop open in the OR to choose which approach will be performed either periareolar Vs infra-mammary approach in minimally invasive cardiac surgery)

入排标准

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

入选标准

  • Patients undergoes mitral or tricuspid valve surgery.
  • lesion of right side of the heart.

排除标准

  • patients undergoing aortic valve or CABG surgery.
  • surgery of left side of the heart.

结局指标

主要结局

Duration of surgery

时间窗: 2 hours

start from skin incision to cardiopulmonary bypass initiation

次要结局

  • rate of surgical site complications(three month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed El Adel Sayed Hassanein Sayed

principal investigator

Assiut University

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