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临床试验/NCT06869980
NCT06869980已完成不适用

Efficacy of Limited Right Anterior Thoracotomy Versus Median Sternotomy for Mitral Valve Replacement

Zagazig University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年5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
已完成
入组人数
41
试验地点
1
主要终点
post operative pain threshold (Visual analog scale (VAS):0 to 10 assess pain from no pain-mild -moderate- sever-worst pain possible

研究概览

简要总结

this study compare between two diffrent methods for approach mitral valve in mitral valve replacement throgh opening of the middle of the sternum by saw or through opening between 4th and 5th rib on the right side of the chest without saw

详细描述

study the efficacy of mitral valve replacement by median sterntomy versus limited right thoractomy

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with acquired isolated mitral valve disease requiring mitral valve replacement > 18 years

排除标准

  • •patients with Previous cardiac surgery, • Patients less than 18 years, • Patients with other valvular heart lesions (aortic valve or tricuspid valve) , IHD Patients , Obese patients (BMI>35), COPD patients

研究组 & 干预措施

Limited Right Anterior Thoracotomy

Experimental

mitral valve replacement through minimal invasive approach

干预措施: mitral valve replacement through limited right anterior thoractomy (Procedure)

median sternotomy

Active Comparator

mitral valve replacement through traditional median sterntomy approach

干预措施: mitral valve replacement through median sterntomy (Procedure)

结局指标

主要结局

post operative pain threshold (Visual analog scale (VAS):0 to 10 assess pain from no pain-mild -moderate- sever-worst pain possible

时间窗: 5 days after surgery

measured by universal pain assessment tool

length of skin incision (cosmotic scar)

时间窗: 1 week after surgery

measured by centimetre by ruler

wound satisfaction scale (quality of life questionnaire)

时间窗: 2 weeks after surgery

modified Likert scale for wond satisfaction:(very dissatisfied,dissatisfied,neutral, satisfied,very satisfied)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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