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临床试验/NCT05527756
NCT05527756已完成不适用

Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.

研究概览

简要总结

Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. Therefore, this study aims to investigate the cosmesis after TECS.

详细描述

Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. One previous study compared median sternotomy cardiac surgery and TECS in terms of the long-term cosmetic appearance of postoperative scars. They concluded that scars were considered more satisfactory, less painful, and itchy in the TECS group in the Chinese population. To our knowledge, this is the only study published regarding cosmetic consequences after TECS. Therefore, this study aims to investigate the cosmesis after TECS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Patients older than 18 years old
  • •Patients who can give their informed consent
  • •Patients who speak Dutch or French

排除标准

  • •Patients that previously underwent cardiac surgery
  • •Patients that will undergo a combination of cardiac surgeries

结局指标

主要结局

Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.

时间窗: Postoperative day 30

The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.

Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 14.

时间窗: Postoperative day 14

The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.

Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day one.

时间窗: Postoperative day one

The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.

次要结局

  • Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day one.(Postoperative day one)
  • Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 14.(Postoperative day 14)
  • Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 30.(Postoperative day 30)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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